Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design
Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and...
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| Autor*in: |
White M [verfasserIn] Mackay M [verfasserIn] Whittaker RG [verfasserIn] |
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E-Artikel |
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Englisch |
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2020 |
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In: Open Access Journal of Clinical Trials - Dove Medical Press, 2010, (2020), Seite 33-41 |
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year:2020 ; pages:33-41 |
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| 520 | |a Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience | ||
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(DE-627)DOAJ065377583 (DE-599)DOAJfb759f5eaf564279b9f1420def6a3ba9 DE-627 ger DE-627 rakwb eng White M verfasserin aut Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience gene therapy implantable device opsins first-in-human neuroscience Medicine R Mackay M verfasserin aut Whittaker RG verfasserin aut In Open Access Journal of Clinical Trials Dove Medical Press, 2010 (2020), Seite 33-41 (DE-627)611725908 (DE-600)2520705-2 11791519 nnns year:2020 pages:33-41 https://doaj.org/article/fb759f5eaf564279b9f1420def6a3ba9 kostenfrei https://www.dovepress.com/taking-optogenetics-into-the-human-brain-opportunities-and-challenges--peer-reviewed-article-OAJCT kostenfrei https://doaj.org/toc/1179-1519 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 33-41 |
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(DE-627)DOAJ065377583 (DE-599)DOAJfb759f5eaf564279b9f1420def6a3ba9 DE-627 ger DE-627 rakwb eng White M verfasserin aut Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience gene therapy implantable device opsins first-in-human neuroscience Medicine R Mackay M verfasserin aut Whittaker RG verfasserin aut In Open Access Journal of Clinical Trials Dove Medical Press, 2010 (2020), Seite 33-41 (DE-627)611725908 (DE-600)2520705-2 11791519 nnns year:2020 pages:33-41 https://doaj.org/article/fb759f5eaf564279b9f1420def6a3ba9 kostenfrei https://www.dovepress.com/taking-optogenetics-into-the-human-brain-opportunities-and-challenges--peer-reviewed-article-OAJCT kostenfrei https://doaj.org/toc/1179-1519 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 33-41 |
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(DE-627)DOAJ065377583 (DE-599)DOAJfb759f5eaf564279b9f1420def6a3ba9 DE-627 ger DE-627 rakwb eng White M verfasserin aut Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience gene therapy implantable device opsins first-in-human neuroscience Medicine R Mackay M verfasserin aut Whittaker RG verfasserin aut In Open Access Journal of Clinical Trials Dove Medical Press, 2010 (2020), Seite 33-41 (DE-627)611725908 (DE-600)2520705-2 11791519 nnns year:2020 pages:33-41 https://doaj.org/article/fb759f5eaf564279b9f1420def6a3ba9 kostenfrei https://www.dovepress.com/taking-optogenetics-into-the-human-brain-opportunities-and-challenges--peer-reviewed-article-OAJCT kostenfrei https://doaj.org/toc/1179-1519 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 33-41 |
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(DE-627)DOAJ065377583 (DE-599)DOAJfb759f5eaf564279b9f1420def6a3ba9 DE-627 ger DE-627 rakwb eng White M verfasserin aut Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience gene therapy implantable device opsins first-in-human neuroscience Medicine R Mackay M verfasserin aut Whittaker RG verfasserin aut In Open Access Journal of Clinical Trials Dove Medical Press, 2010 (2020), Seite 33-41 (DE-627)611725908 (DE-600)2520705-2 11791519 nnns year:2020 pages:33-41 https://doaj.org/article/fb759f5eaf564279b9f1420def6a3ba9 kostenfrei https://www.dovepress.com/taking-optogenetics-into-the-human-brain-opportunities-and-challenges--peer-reviewed-article-OAJCT kostenfrei https://doaj.org/toc/1179-1519 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 33-41 |
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(DE-627)DOAJ065377583 (DE-599)DOAJfb759f5eaf564279b9f1420def6a3ba9 DE-627 ger DE-627 rakwb eng White M verfasserin aut Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience gene therapy implantable device opsins first-in-human neuroscience Medicine R Mackay M verfasserin aut Whittaker RG verfasserin aut In Open Access Journal of Clinical Trials Dove Medical Press, 2010 (2020), Seite 33-41 (DE-627)611725908 (DE-600)2520705-2 11791519 nnns year:2020 pages:33-41 https://doaj.org/article/fb759f5eaf564279b9f1420def6a3ba9 kostenfrei https://www.dovepress.com/taking-optogenetics-into-the-human-brain-opportunities-and-challenges--peer-reviewed-article-OAJCT kostenfrei https://doaj.org/toc/1179-1519 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 33-41 |
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Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience |
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Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience |
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Michael White,1 Michael Mackay,1 Roger G Whittaker1,2 1Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK; 2Department of Clinical Neurophysiology, Royal Victoria Hospital, Newcastle Upon Tyne NE1 4LP, UKCorrespondence: Michael WhiteTranslational and Clinical Research Institute, Newcastle University, Framlington Place, Newcastle Upon Tyne NE2 4HH, UKTel +44 (0) 191 208 3281Email Michael.white2ncl.ac.ukAbstract: Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.Keywords: gene therapy, implantable device, opsins, first-in-human, neuroscience |
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