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	<title>news &#8211; Neuromod+</title>
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	<description>Co-creation for next-generation neuromodulation therapeutics</description>
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	<title>news &#8211; Neuromod+</title>
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		<title>Advancing UK Neurotechnology: Reflections on Our Joint Symposium</title>
		<link>https://neuromodplus.org/2026/01/19/advancing-uk-neurotechnology-reflections-on-our-joint-symposium/</link>
					<comments>https://neuromodplus.org/2026/01/19/advancing-uk-neurotechnology-reflections-on-our-joint-symposium/#respond</comments>
		
		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Mon, 19 Jan 2026 11:27:08 +0000</pubDate>
				<category><![CDATA[events]]></category>
		<category><![CDATA[news]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=7966</guid>

					<description><![CDATA[The closeNIT and Neuromod+ networks have been working closely to foster collaboration across the neuroscience and neurotechnology communities, including co-hosting the second UK Symposium on Neuromodulation and Neurotechnology on 25–26 [&#8230;]]]></description>
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									<p>The closeNIT and Neuromod+ networks have been working closely to foster collaboration across the neuroscience and neurotechnology communities, including co-hosting the second UK Symposium on Neuromodulation and Neurotechnology on 25–26 November in Newcastle upon Tyne. The two-day meeting brought together researchers from diverse disciplines for stimulating discussion and networking, with sessions covering neuromodulation for cognition and mental health, the implementation of neurotechnology in neurology and psychiatry, recent advances in the field and the commercialisation and regulation of emerging technologies.</p><p>As both projects near their end, we are committed to maintaining the strong collaboration and momentum built through these networks. Representatives from both networks are planning an annual meeting – the next to be hosted in Oxford towards the end of 2026 – to continue to develop activity in the space, and carry forward the legacy of a cohesive neurotechnology community in the UK.</p>								</div>
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		<title>Making Brain Research More Inclusive</title>
		<link>https://neuromodplus.org/2025/10/22/making-brain-research-more-inclusive/</link>
					<comments>https://neuromodplus.org/2025/10/22/making-brain-research-more-inclusive/#respond</comments>
		
		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Wed, 22 Oct 2025 13:50:28 +0000</pubDate>
				<category><![CDATA[news]]></category>
		<category><![CDATA[EDI]]></category>
		<category><![CDATA[inclusivity]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=7926</guid>

					<description><![CDATA[A new video, from Neuromod+ awardee Mahnaz Arvaneh and team, highlights the importance of diversity in in brain research. The collaborative  team were awarded funding from Neuromod+ for their projects: [&#8230;]]]></description>
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									<p>A <a href="https://www.youtube.com/watch?v=Mp6FU8QgzK0" target="_blank" rel="noopener">new video</a>, from Neuromod+ awardee Mahnaz Arvaneh and team, highlights the importance of diversity in in brain research. The collaborative  team were awarded funding from Neuromod+ for their projects: &#8220;Fostering Acceptance and Inclusivity of Non-Invasive Neurotechnology in African Ethnic Minority Communities&#8221; and the follow-up &#8220;Bridging the Gap: Promoting Acceptance and Inclusivity of Non-Invasive Neurotechnology in Ethnic Minority Communities&#8221;.</p><p>Mahnaz writes &#8220;Brain research and neurotechnologies are transforming healthcare, from understanding how the brain works to developing new treatments for conditions like stroke and epilepsy. But these technologies don’t always work equally well for everyone. Biological and phenotypic factors—such as hair type, skin tone, head size, skull thickness, and hormonal differences—can all influence how well neurotechnologies capture brain signals. This means that if research excludes people from diverse backgrounds, the results may not be reliable or beneficial for all communities. Despite this, participants from minority populations remain critically underrepresented in UK neurotechnology studies. A University of Sheffield-led project, funded by the UKRI Neuromod+ Network, set out to change this.</p><p>In collaboration with the Israac Community Centre in Sheffield, researchers co-designed interactive workshops to explore how communities engage with brain research. Shaped around cultural needs, these sessions built trust, improved understanding, and revealed practical barriers and solutions—leading to recommendations for more inclusive study designs and even a prototype EEG electrode.</p><p>The project was a joint effort between the University of Sheffield (led by Dr Mahnaz Arvaneh and Dr Dan Blackburn) and the NIHR Devices for Dignity MedTech Co-operative (led by Lise Sproson). It highlights the value of working directly with communities to build trust, raise awareness, and adapt research tools that make participation easier and more representative.</p><p>To share the outcomes, the team created a short video, designed to raise awareness among both researchers and communities about the importance of diversity in brain research.</p><p>This work provides a model for inclusive, community-led neurotechnology research that can be replicated across the UK and beyond.&#8221;</p><p><strong>View and share the video here: <a href="https://www.youtube.com/watch?v=Mp6FU8QgzK0" target="_blank" rel="noopener">Equality &amp; Diversity in Neuroscience</a></strong></p><p>This work has also been reported in the EPSRC Healthcare Technologies Newsletter Oct 25.</p>								</div>
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		<title>Have your say on neuromodulation!</title>
		<link>https://neuromodplus.org/2025/06/25/have-your-say-on-neuromodulation/</link>
					<comments>https://neuromodplus.org/2025/06/25/have-your-say-on-neuromodulation/#respond</comments>
		
		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Wed, 25 Jun 2025 13:41:42 +0000</pubDate>
				<category><![CDATA[news]]></category>
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		<category><![CDATA[study]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=7828</guid>

					<description><![CDATA[Researchers at the Nottingham Institute of Mental Health have launched a survey to understand what people think about &#8220;neuromodulation&#8221; (non-invasive brain stimulation) treatments for mental health conditions. This survey was [&#8230;]]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">Researchers at the Nottingham Institute of Mental Health have launched a survey to understand what people think about &#8220;neuromodulation&#8221; (non-invasive brain stimulation) treatments for mental health conditions. This survey was partly developed with funding from a Neuromod+ flexible funding award.</p>



<p class="wp-block-paragraph">The survey will help researchers and clinicians developing neuromodulation treatments to design clinical trials and information resources that better meet patient needs.</p>



<p class="wp-block-paragraph">All entrants will have the opportunity of winning an Amazon voucher, and can choose to be notified about follow-up focus groups/interviews or future neuromodulation research studies.</p>



<p class="wp-block-paragraph">The team are particularly interested in the views of people with lived experience of mental health difficulties (whether diagnosed or self-identified), as well as carers for people with mental health difficulties.</p>



<p class="wp-block-paragraph">Participants do not need to have any previous knowledge or experience of neuromodulation. The survey includes short videos and infographics demonstrating the treatments.</p>



<p class="wp-block-paragraph">If you&#8217;re interested in finding out more or taking part, scan the QR-code in the poster or visit: <a href="https://bit.ly/nm-survey">https://bit.ly/nm-survey</a></p>
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		<title>Five new feasibility studies funded in third and final Neuromod+ funding call</title>
		<link>https://neuromodplus.org/2024/10/23/five-new-feasibility-studies-funded-in-third-and-final-neuromod-funding-call/</link>
					<comments>https://neuromodplus.org/2024/10/23/five-new-feasibility-studies-funded-in-third-and-final-neuromod-funding-call/#respond</comments>
		
		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Wed, 23 Oct 2024 20:05:22 +0000</pubDate>
				<category><![CDATA[funding]]></category>
		<category><![CDATA[news]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=7344</guid>

					<description><![CDATA[Five original projects have been funded by Neuromod+ in our final call for feasibility studies.  Mahnaz Arvaneh, Daniel Blackburn, Lise Sproson &#38; Ismail Yussuf&#8217;s Bridging the Gap: Promoting Acceptance and [&#8230;]]]></description>
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									<p>Five original projects have been funded by Neuromod+ in our final call for feasibility studies. </p><p><strong>Mahnaz Arvaneh, Daniel Blackburn, Lise Sproson &amp; Ismail Yussuf&#8217;s </strong><em>Bridging the Gap: Promoting Acceptance and Inclusivity of Non-Invasive Neurotechnology in Ethnic Minority Communities </em>builds on their previous Neuromod+ award, <em>Fostering Acceptance and Inclusivity of Non-Invasive Neurotechnology in African Ethnic Minority Communities, </em>to co-create video interviews with end users and clinicians, to address the unique needs and concerns of these communities, and demonstrate the positive impact of neurotechnology on health and well-being, promoting its acceptance and inclusivity.</p><p><strong>Elsa Fouragnan &amp; Samuel Hughes&#8217;s </strong><em>Leveraging Multisite Transcranial Ultrasound Stimulation of the Dorsal Anterior Cingulate Cortex for Endogenous Pain Modulation </em>aims to pave the way for groundbreaking clinical applications in pain management by capitalising on the response of brain cells to transcranial ultrasound stimulation (TUS) to precisely target multiple subsections of the dorsal anterior cingulate cortex.</p><p><strong>Richard Morriss &amp; Paul Briley&#8217;s </strong><em>Personalised dual-site dual-device neuromodulation for anxiety </em>will investigate the mechanisms of action of simultaneous transcranial magnetic stimulation (TMS) and transcranial alternating current stimulation (tACS), and its potential for treating anxiety symptoms.</p><p><strong>Kat Dyke, Domenica Veniero, Lugi tame and Nicholas Holmes&#8217;s </strong><em>Reliability and optimization of somatosensory afferent inhibition (SAI) as a clinical biomarker in healthy ageing </em>will combine non-invasive brain stimulation and a brain imaging approach called ‘electroencephalography’ (EEG) to improve understanding of how the healthy brain ages.</p><p><strong>Charlotte Stagg, Polytimi Frangou, Saad Jbabdi, William Clarke, Elly Martin &amp; Angelika Zarkali&#8217;s </strong><em>Using neurophysiology and multimodal MRI to characterise cholinergic potentiation by Focused Ultrasound Neuromodulation of deep- and mid-brain structures</em><em> </em>will use focused ultrasound neuromodulation and spectroscopic imaging tools to investigate the role of Acetylcholine (ACh) in the human brain. ACh is one of the most important neurochemicals in the brain and its deficit is linked to neurodegenerative disorders including Alzheimer’s and Parkinson’s. The study will set foundations for developing ACh-enhancing therapeutic interventions against cholinergic deficits.</p><div>We congratulate all our awardees and look forward to seeing how their projects progress.</div>								</div>
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		<title>Seven innovative projects awarded in second Neuromod+ funding call</title>
		<link>https://neuromodplus.org/2024/02/20/seven-innovative-projects-awarded-in-second-neuromod-funding-call/</link>
					<comments>https://neuromodplus.org/2024/02/20/seven-innovative-projects-awarded-in-second-neuromod-funding-call/#respond</comments>
		
		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Tue, 20 Feb 2024 14:49:32 +0000</pubDate>
				<category><![CDATA[funding]]></category>
		<category><![CDATA[news]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=6593</guid>

					<description><![CDATA[We are delighted to have been able to award seven new projects in the latest Neuromod+ funding call. Projects cover varied topics, from acceptance of neurotechnology among ethnic minority communities, [&#8230;]]]></description>
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									<p>We are delighted to have been able to award seven new projects in the latest Neuromod+ funding call. Projects cover varied topics, from acceptance of neurotechnology among ethnic minority communities, to investigating how focussed ultrasound works in neuromodulation and looking at new approaches for enhancing memory performance. The wide range of disorders addressed in the funded projects (including motor neurone disease, memory disorders, mental health conditions and other neurological and neurodegenerative conditions), highlight the potential of minimally invasive neuromodulation to be applied to a huge variety of conditions and disorders.</p>
<p>A list of the projects awarded is below. Find out more on the <a href="https://neuromodplus.org/funding/funded_projects/">funding page</a> of our website.</p>
<ul>
<li><strong>Mahnaz Arvaneh</strong>: <em>Fostering Acceptance and Inclusivity of Non-Invasive Neurotechnology in African Ethnic Minority Communities</em></li>
<li><strong>Rob Dineen</strong>: <em>Clinical Trial Readiness for Non-Invasive Therapeutic Neuromodulation in Ataxia Telangiectasia</em></li>
<li><strong>Tracy Farr</strong>: <em>Understanding the mechanisms by which low intensity focussed ultrasound is able to modulate neural activity</em></li>
<li><strong>Marcus Kaiser</strong>: <em>Closed-loop focused ultrasound neuromodulation: Testing different strategies in healthy human participants</em></li>
<li><strong>Alekhya Mandali</strong>: <em>Optimising transcranial electrical stimulation for motor neurone disease</em></li>
<li><strong>Jacinta O’Shea</strong>: <em>Remediating depressive cognition using a novel brain stimulation device</em></li>
<li><strong>Simon Schultz</strong>: <em>Sharp-wave ripple triggered neuromodulation for memory enhancement</em></li>
</ul>
<div>Congratulations to our awardees and thank you to all the teams who submitted a proposal.<br>Our third call for funding for feasibility studies will open in late in 2024.</div>								</div>
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		<title>Neuromodulation survey suggests that patients and public prefer safe and noninvasive neuromodulation for mental health</title>
		<link>https://neuromodplus.org/2024/01/17/neuromodulation-survey-suggests-that-patients-and-public-prefer-safe-and-noninvasive-neuromodulation-for-mental-health/</link>
					<comments>https://neuromodplus.org/2024/01/17/neuromodulation-survey-suggests-that-patients-and-public-prefer-safe-and-noninvasive-neuromodulation-for-mental-health/#respond</comments>
		
		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Wed, 17 Jan 2024 15:49:49 +0000</pubDate>
				<category><![CDATA[news]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=6394</guid>

					<description><![CDATA[A large-scale online survey of patients and the general public, led by researchers at Nottingham University, has captured views on using neuromodulation for brain and mental health interventions. The survey [&#8230;]]]></description>
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<p class="wp-block-paragraph">A large-scale online survey of patients and the general public, led by researchers at Nottingham University, has captured views on using neuromodulation for brain and mental health interventions. The survey results suggest that noninvasive methods are preferred, and considered safe for mental health interventions.</p>



<p class="wp-block-paragraph">Find out more about the survey and see the results here: <a href="https://www.medrxiv.org/content/10.1101/2024.01.10.24301043v2">A large-scale online survey of patients and the general public: Preferring safe and noninvasive neuromodulation for mental health | medRxiv</a>  </p>



<p class="wp-block-paragraph"></p>
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		<title>Novel MRI technique could help patients with severe depression</title>
		<link>https://neuromodplus.org/2024/01/17/novel-mri-technique-could-help-patients-with-severe-depression/</link>
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		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Wed, 17 Jan 2024 15:31:43 +0000</pubDate>
				<category><![CDATA[news]]></category>
		<category><![CDATA[BRIGhTMIND study]]></category>
		<category><![CDATA[depression]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[TMS]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=6385</guid>

					<description><![CDATA[The BRIGhTMIND trial, led by Neuromod+ member Richard Morriss at Nottingham University, has reported that the use of TMS in conjunction with MRI scans could ease symptoms of depression for [&#8230;]]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">The BRIGhTMIND trial, led by Neuromod+ member Richard Morriss at Nottingham University,  has reported that the use of TMS in conjunction with MRI scans could ease symptoms of depression for up to six months.  See details of the study &#8220;Connectivity-guided intermittent theta burst versus repetitive transcranial magnetic stimulation for treatment-resistant depression: a randomized controlled trial&#8221; reported in <a href="https://www.nature.com/articles/s41591-023-02764-z">Nature Medicine</a>, and reports in the media, including by <a href="https://www.ukri.org/news/novel-mri-technique-could-help-patients-with-severe-depression/">UKRI</a> and <a href="https://www.independent.co.uk/news/health/mri-scan-depression-tms-study-b2479300.html">The Independent</a>.  </p>
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		<title>Article on Connection between Alzheimer’s disease and gut microbiota</title>
		<link>https://neuromodplus.org/2023/03/21/article-on-connection-between-alzheimers-disease-and-gut-microbiota/</link>
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		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Tue, 21 Mar 2023 18:58:49 +0000</pubDate>
				<category><![CDATA[news]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=1641</guid>

					<description><![CDATA[Further to some interesting discussions at the Neuromod+ co-creation event about the link between gut health and the brain, members may be interested to read the following article from the [&#8230;]]]></description>
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<p class="wp-block-paragraph">Further to some interesting discussions at the Neuromod+ co-creation event about the link between gut health and the brain, members may be interested to read the following article from the Brain Health Network: <a href="https://brain.health/blog/news/2020/12/link-between-alzheimers-disease-and-gut-microbiota-confirmed/?_kx=gDdH22N8_tjoK43_SUSK5qGP1K1DJD4epWadJUyRGVSjA2fDc-H886o_--ZfWHFd.SjwCQJ">Connection between Alzheimer’s disease and gut microbiota (brain.health)</a></p>
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		<title>Critical conversations: How could neurotechnology reshape our lives?</title>
		<link>https://neuromodplus.org/2023/01/31/critical-conversations-how-could-neurotechnology-reshape-our-lives/</link>
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		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Tue, 31 Jan 2023 12:05:24 +0000</pubDate>
				<category><![CDATA[news]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=1383</guid>

					<description><![CDATA[Watch a recording of the Royal Academy of Engineering&#8217;s &#8220;Critical Conversation&#8221; on how neurotechnology could reshape our lives, featuring Chairs in Emerging Technologies Professor Timothy Denison and Professor Keith Mathieson [&#8230;]]]></description>
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<p class="wp-block-paragraph">Watch a recording of the Royal Academy of Engineering&#8217;s &#8220;Critical Conversation&#8221; on how neurotechnology could reshape our lives, featuring Chairs in Emerging Technologies Professor Timothy Denison and Professor Keith Mathieson in discussion with Academy CEO, Dr Hayaatun Sillem CBE.</p>



<p class="wp-block-paragraph"><a href="https://raeng.org.uk/events/2023/january/critical-conversations-how-could-neurotechnology-reshape-our-lives" data-type="URL" data-id="https://raeng.org.uk/events/2023/january/critical-conversations-how-could-neurotechnology-reshape-our-lives" target="_blank" rel="noreferrer noopener">https://raeng.org.uk/events/2023/january/critical-conversations-how-could-neurotechnology-reshape-our-lives</a></p>
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		<title>Opposition to EU Reclassification of TMS and tDCS equipment to Class III devices</title>
		<link>https://neuromodplus.org/2023/01/10/manifesto-opposition-to-eu-reclassification-of-tms-and-tdcs-equipment-to-class-iii-devices-based-on-flawed-evidence/</link>
					<comments>https://neuromodplus.org/2023/01/10/manifesto-opposition-to-eu-reclassification-of-tms-and-tdcs-equipment-to-class-iii-devices-based-on-flawed-evidence/#respond</comments>
		
		<dc:creator><![CDATA[Kate Hobson]]></dc:creator>
		<pubDate>Tue, 10 Jan 2023 18:10:19 +0000</pubDate>
				<category><![CDATA[news]]></category>
		<category><![CDATA[regulatory]]></category>
		<guid isPermaLink="false">https://neuromodplus.org/?p=1324</guid>

					<description><![CDATA[Dear all,please see below an email from the European Society for Brain Stimulation which relates to recent EU reclassification of NIBS devices that has become law since December and is [&#8230;]]]></description>
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<p class="wp-block-paragraph">Dear all,<br>please see below an email from the European Society for Brain Stimulation which relates to recent EU reclassification of NIBS devices that has become law since December and is based on a flawed consultation process, inaccurate safety claims and equating the NIBS safety risk profile to that of invasive DBS.  The ESBS is strongly opposed and believes it is likely to adversely affect the NIBS research community.  Individuals are encouraged to email the relevant EU body to register their protest (template below), in an effort to overturn this decision.<br>[sent on behalf of Network member Dr Jacinta O&#8217;Shea, Oxford Centre for Human Brain Activity (OHBA), Wellcome Centre for Integrative Neuroimaging, Department of Psychiatry, University of Oxford]</p>



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<p class="wp-block-paragraph"><strong>Manifesto</strong></p>



<p class="wp-block-paragraph">The European Society for Brain Stimulation (ESBS) is an independent and professional association of medical doctors, psychologists, neuroscientists, and others practising and interested in Non-Invasive Brain Stimulation (NIBS) techniques such as repetitive transcranial magnetic stimulation (rTMS) and direct current stimulation (tDCS). Our mission is to promote public and accessible health care, research, and training in the field of brain stimulation and to foster the dissemination of knowledge about brain stimulation to clinicians, researchers, patients and governmental bodies such as the Notified Bodies of EU countries. Our aim is to provide independent and factual up-to-date information about the field of non-invasive brain stimulation. In all of our research and clinical applications, the safety of our patients and research participants has the highest priority. Therefore, we give guidance to stakeholders (policy-makers, manufacturers, researchers, health care providers) on how to improve patient safety and advise them to use only certified medical products.&nbsp;</p>



<p class="wp-block-paragraph">It has recently come to our attention that the EU has reclassified the NIBS equipments including rTMS and tDCS, as <strong>Class III devices</strong>, <strong>the category of highest risk</strong>, similar to invasive treatments, such as deep-brain stimulation implants. This reclassification has a major impact on our field, not only for manufacturers, but also for researchers, clinicians and patients and we judge this reclassification a mistake. First, the evidential basis for this change is a flawed assessment of the safety literature. Second, the consultation process has occurred without input from specialists or stakeholders professionally active in the field of NIBS. Neither the ESBS nor National Societies of Brain Stimulation nor individual experts within the European NIBS community were consulted on this change. Third, this decision will ultimately make NIBS treatment less accessible to patients and will hamper research and development for neuroscience and for new clinical indications. We explain this in detail below. This manifesto is also a call to action. You (whether a researcher, clinician, manufacturer or concerned citizen) can still act, by sending a letter of concern to EU representatives.</p>



<p class="wp-block-paragraph">As a community, we have by now almost 30 years of experience using NIBS technologies for research and clinical applications. Data acquired over this period has been collected to carefully assess the behavioral, neurocognitive, physiological, and biophysical effects on the central nervous system. These studies have not only informed us about the clinical efficacy of NIBS and resulted in new evidence-based non-pharmacological treatments for neurological and psychiatric disorders that are used in a growing number of countries worldwide, but have also informed us about the risks, adverse and side effects that can occur when applying NIBS to the human brain. Based on this vast amount of safety data collected over the past 30 years, several publications, meta-analyses, reviews, guidelines and consensus papers have provided peer-reviewed evidence-based assessments of the safety of TMS (see e.g., Rossi et al., 2020) as well as low output transcranial electric stimulation, TES (see e.g.&nbsp; Antal et al., 2017, 2022;&nbsp; Bikson et al., 2017; Caulfield et al, 2022; Zewdie et al., 2020). <em><strong>Based on these data, the current scientific and clinical evidence suggests both rTMS and low intensity TES are safe treatment and research interventions with few and mild adverse effects.&nbsp;</strong></em></p>



<p class="wp-block-paragraph">Although this new reclassification currently refers only to “<strong>products without an intended medical purpose</strong>”, the evidence adduced about the risks and adverse effects of rTMS and TES, &#8211; which serves as the justification for this reclassification-, is gravely flawed. The EU has apparently assessed that NIBS poses a greater risk to patients&#8217; safety than previously thought. <em><strong>This assessment is based on incorrect statements about rTMS and low intensity TES that are contradictory to the available scientific evidence, and many of the stated claims and assumptions are false </strong></em>(e.g. it is claimed that TMS/TES can induce “atypical brain development” or “abnormal patterns of brain activity”). Likewise, the prominent mentioning of rTMS/TES-related seizure risks contradicts the most recent consensus statement in the field based on actual clinical data which demonstrated that observed seizure rates are so much lower than previous guidelines advised, that the prior caution about seizure risk is no longer supported by scientific evidence (Rossi et al., 2020). To put this into perspective, the likelihood of a seizure from rTMS (0.003%) is lower than that associated with the use of antidepressants and antipsychotics (0.1-1,5%), which are one of the most frequently prescribed treatments for depression. Moreover, when such seizures occur they do so mostly outside the clinician’s office, by contrast with rTMS (Perera et al., 2016, Pisanie et al., 2002).&nbsp; For low intensity tDCS, tACS, tRNS seizure risk is completely absent.&nbsp;</p>



<p class="wp-block-paragraph">As an organisation and representatives of NIBS clinicians and professionals from across Europe, we, the ESBS, therefore disagree with this EU decision and in particular with the factually incorrect justifications of that decision to reclassify TMS and TES as invasive technologies that require medical class-III classification. The impact of this reclassification will result in higher costs, lower accessibility for patients to treatment and substantial delays in NIBS development for new clinical and research indications. We agree that all transcranial brain stimulation devices must be certified medical devices, class IIa, to be used clinically only under supervision of a clinician and trained personnel, and used in basic research after approval of a local ethical committee. However, to reclassify NIBS devices as having the same level of risk as invasive brain stimulation devices that are implanted inside the brain, is inappropriate, contradicts 30 years of safety data, and has been decided without consultation of relevant professionals.&nbsp;&nbsp;</p>



<p class="wp-block-paragraph">Therefore, if you are in agreement with the concerns stated above, we kindly ask you to protest this decision by sending an email to <a href="mailto:sante-med-dev@ec.europa.eu"><strong>sante-med-dev@ec.europa.eu</strong></a>. <a href="https://docs.google.com/document/d/1fBEKHJswztrqfRt6VQsen8Xk1OERwD0aF583WXuDBOM/edit?usp=sharing">Here</a> you can find suggested text for your email. Please feel free to modify it.&nbsp; Note: it is our understanding that the greater the number of individual emails that are sent in protest, the greater the likely impact. So please send an email on your own behalf and disseminate widely across your network of NIBS colleagues in order to maximize impact.&nbsp;</p>



<p class="wp-block-paragraph">On behalf of the European Society of Brain Stimulation (ESBS)</p>



<p class="wp-block-paragraph"><a href="https://www.brain-stimulation.eu/">https://www.brain-stimulation.eu/</a></p>



<p class="wp-block-paragraph">Chris Baeken, President Andrea Antal, Vice-President</p>
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