Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up study
Introduction Deep brain stimulation (DBS) of bilateral anteromedial subthalamic nucleus (amSTN) has been found to be helpful in a subset of patients with severe, chronic and treatment-refractory obsessive–compulsive disorder (OCD). Biomarkers may aid in patient selection and optimisation of this inv...
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doaj-d3f1532edb5d4fad89893136dd4381242021-08-07T17:02:32ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111610.1136/bmjopen-2020-047492Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up studyLuc Mallet0Shyam Sundar Arumugham1Dwarakanath Srinivas2Janardhanan C Narayanaswamy3TS Jaisoorya4Himani Kashyap5Philippe Domenech6Stéphane Palfi7Ganesan Venkatasubramanian8YC Janardhan Reddy97 Institut du Cerveau, ICM, Inserm U 1127, CNRS UMR 7225, Sorbonne Université, F-75013, Paris, France Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, IndiaDepartment of Neurosurgery, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, IndiaDepartment of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, IndiaDepartment of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, IndiaDepartment of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, IndiaUniv Paris-Est Créteil, DMU CARE - Département Médical-Universitaire de Chirurgie et Anesthésie réanimation, DMU IMPACT, Département Médical-Universitaire de Psychiatrie et d’Addictologie, Hôpitaux Universitaires Henri Mondor, Creteil, FranceUniv Paris-Est Créteil, DMU CARE - Département Médical-Universitaire de Chirurgie et Anesthésie réanimation, DMU IMPACT, Département Médical-Universitaire de Psychiatrie et d’Addictologie, Hôpitaux Universitaires Henri Mondor, Creteil, FranceDepartment of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, IndiaDepartment of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, IndiaIntroduction Deep brain stimulation (DBS) of bilateral anteromedial subthalamic nucleus (amSTN) has been found to be helpful in a subset of patients with severe, chronic and treatment-refractory obsessive–compulsive disorder (OCD). Biomarkers may aid in patient selection and optimisation of this invasive treatment. In this trial, we intend to evaluate neurocognitive function related to STN and related biosignatures as potential biomarkers for STN DBS in OCD.Methods and analysis Twenty-four subjects with treatment-refractory OCD will undergo open-label STN DBS. Structural/functional imaging, electrophysiological recording and neurocognitive assessment would be performed at baseline. The subjects would undergo a structured clinical assessment for 12 months postsurgery. A group of 24 healthy volunteers and 24 subjects with treatment-refractory OCD who receive treatment as usual would be recruited for comparison of biomarkers and treatment response, respectively. Baseline biomarkers would be evaluated as predictors of clinical response. Neuroadaptive changes would be studied through a reassessment of neurocognitive functioning, imaging and electrophysiological activity post DBS.Ethics and dissemination The protocol has been approved by the National Institute of Mental Health and Neurosciences Ethics Committee. The study findings will be disseminated through peer-reviewed scientific journals and scientific meetings.https://bmjopen.bmj.com/content/11/6/e047492.full |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Luc Mallet Shyam Sundar Arumugham Dwarakanath Srinivas Janardhanan C Narayanaswamy TS Jaisoorya Himani Kashyap Philippe Domenech Stéphane Palfi Ganesan Venkatasubramanian YC Janardhan Reddy |
spellingShingle |
Luc Mallet Shyam Sundar Arumugham Dwarakanath Srinivas Janardhanan C Narayanaswamy TS Jaisoorya Himani Kashyap Philippe Domenech Stéphane Palfi Ganesan Venkatasubramanian YC Janardhan Reddy Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up study BMJ Open |
author_facet |
Luc Mallet Shyam Sundar Arumugham Dwarakanath Srinivas Janardhanan C Narayanaswamy TS Jaisoorya Himani Kashyap Philippe Domenech Stéphane Palfi Ganesan Venkatasubramanian YC Janardhan Reddy |
author_sort |
Luc Mallet |
title |
Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up study |
title_short |
Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up study |
title_full |
Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up study |
title_fullStr |
Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up study |
title_full_unstemmed |
Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up study |
title_sort |
identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive–compulsive disorder: protocol for an open-label follow-up study |
publisher |
BMJ Publishing Group |
series |
BMJ Open |
issn |
2044-6055 |
publishDate |
2021-06-01 |
description |
Introduction Deep brain stimulation (DBS) of bilateral anteromedial subthalamic nucleus (amSTN) has been found to be helpful in a subset of patients with severe, chronic and treatment-refractory obsessive–compulsive disorder (OCD). Biomarkers may aid in patient selection and optimisation of this invasive treatment. In this trial, we intend to evaluate neurocognitive function related to STN and related biosignatures as potential biomarkers for STN DBS in OCD.Methods and analysis Twenty-four subjects with treatment-refractory OCD will undergo open-label STN DBS. Structural/functional imaging, electrophysiological recording and neurocognitive assessment would be performed at baseline. The subjects would undergo a structured clinical assessment for 12 months postsurgery. A group of 24 healthy volunteers and 24 subjects with treatment-refractory OCD who receive treatment as usual would be recruited for comparison of biomarkers and treatment response, respectively. Baseline biomarkers would be evaluated as predictors of clinical response. Neuroadaptive changes would be studied through a reassessment of neurocognitive functioning, imaging and electrophysiological activity post DBS.Ethics and dissemination The protocol has been approved by the National Institute of Mental Health and Neurosciences Ethics Committee. The study findings will be disseminated through peer-reviewed scientific journals and scientific meetings. |
url |
https://bmjopen.bmj.com/content/11/6/e047492.full |
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