Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol
Introduction Therapeutic interventions for disorders of consciousness lack consistency; evidence supports non-invasive brain stimulation, but few studies assess neuromodulation in acute-to-subacute brain-injured patients. This study aims to validate the feasibility and assess the effect of a multi-s...
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BMJ Publishing Group
2024-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/7/e078281.full |
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| author | David Williamson Francis Bernard Stefanie Blain-Moraes Caroline Arbour Virginie Williams Louis de Beaumont Catherine Duclos Béatrice P De Koninck Daphnee Brazeau Amelie A Deshaies Marie-Michele Briand Charlotte Maschke |
| author_facet | David Williamson Francis Bernard Stefanie Blain-Moraes Caroline Arbour Virginie Williams Louis de Beaumont Catherine Duclos Béatrice P De Koninck Daphnee Brazeau Amelie A Deshaies Marie-Michele Briand Charlotte Maschke |
| author_sort | David Williamson |
| collection | DOAJ |
| description | Introduction Therapeutic interventions for disorders of consciousness lack consistency; evidence supports non-invasive brain stimulation, but few studies assess neuromodulation in acute-to-subacute brain-injured patients. This study aims to validate the feasibility and assess the effect of a multi-session transcranial alternating current stimulation (tACS) intervention in subacute brain-injured patients on recovery of consciousness, related brain oscillations and brain network dynamics.Methods and analyses The study is comprised of two phases: a validation phase (n=12) and a randomised controlled trial (n=138). Both phases will be conducted in medically stable brain-injured adult patients (traumatic brain injury and hypoxic-ischaemic encephalopathy), with a Glasgow Coma Scale score ≤12 after continuous sedation withdrawal. Recruitment will occur at the intensive care unit of a Level 1 Trauma Centre in Montreal, Quebec, Canada. The intervention includes a 20 min 10 Hz tACS at 1 mA intensity or a sham session over parieto-occipital cortical sites, repeated over five consecutive days. The current’s frequency targets alpha brain oscillations (8–13 Hz), known to be associated with consciousness. Resting-state electroencephalogram (EEG) will be recorded four times daily for five consecutive days: pre and post-intervention, at 60 and 120 min post-tACS. Two additional recordings will be included: 24 hours and 1-week post-protocol. Multimodal measures (blood samples, pupillometry, behavioural consciousness assessments (Coma Recovery Scale-revised), actigraphy measures) will be acquired from baseline up to 1 week after the stimulation. EEG signal analysis will focus on the alpha bandwidth (8–13 Hz) using spectral and functional network analyses. Phone assessments at 3, 6 and 12 months post-tACS, will measure long-term functional recovery, quality of life and caregivers’ burden.Ethics and dissemination Ethical approval for this study has been granted by the Research Ethics Board of the CIUSSS du Nord-de-l’Île-de-Montréal (Project ID 2021–2279). The findings of this two-phase study will be submitted for publication in a peer-reviewed academic journal and submitted for presentation at conferences. The trial’s results will be published on a public trial registry database (ClinicalTrials.gov).Trial registration number NCT05833568. |
| format | Article |
| id | doaj-art-3d35036793e74ca18f3f7f5013d69b60 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-3d35036793e74ca18f3f7f5013d69b602025-02-01T23:15:15ZengBMJ Publishing GroupBMJ Open2044-60552024-07-0114710.1136/bmjopen-2023-078281Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocolDavid Williamson0Francis Bernard1Stefanie Blain-Moraes2Caroline Arbour3Virginie Williams4Louis de Beaumont5Catherine Duclos6Béatrice P De Koninck7Daphnee Brazeau8Amelie A Deshaies9Marie-Michele Briand10Charlotte Maschke11Research Centre, Centre Intégré Universitaire de Santé et de Services Sociaux du Nord-de-l’île-de-Montréal, Montréal, Québec, CanadaDepartment of Medicine, Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada6 Montreal General Hospital, Montreal, Quebec, Canada2 Research Center, Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada2 Research Center, Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada2 Research Center, Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada2 Research Center, Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada1 Psychology, University of Montreal, Montreal, Quebec, Canada1 Psychology, University of Montreal, Montreal, Quebec, Canada3 CIUSSS du Nord-de-l`Ile-de-Montreal, Montreal, Quebec, Canada3 CIUSSS du Nord-de-l`Ile-de-Montreal, Montreal, Quebec, Canada5 McGill University, Montreal, Quebec, CanadaIntroduction Therapeutic interventions for disorders of consciousness lack consistency; evidence supports non-invasive brain stimulation, but few studies assess neuromodulation in acute-to-subacute brain-injured patients. This study aims to validate the feasibility and assess the effect of a multi-session transcranial alternating current stimulation (tACS) intervention in subacute brain-injured patients on recovery of consciousness, related brain oscillations and brain network dynamics.Methods and analyses The study is comprised of two phases: a validation phase (n=12) and a randomised controlled trial (n=138). Both phases will be conducted in medically stable brain-injured adult patients (traumatic brain injury and hypoxic-ischaemic encephalopathy), with a Glasgow Coma Scale score ≤12 after continuous sedation withdrawal. Recruitment will occur at the intensive care unit of a Level 1 Trauma Centre in Montreal, Quebec, Canada. The intervention includes a 20 min 10 Hz tACS at 1 mA intensity or a sham session over parieto-occipital cortical sites, repeated over five consecutive days. The current’s frequency targets alpha brain oscillations (8–13 Hz), known to be associated with consciousness. Resting-state electroencephalogram (EEG) will be recorded four times daily for five consecutive days: pre and post-intervention, at 60 and 120 min post-tACS. Two additional recordings will be included: 24 hours and 1-week post-protocol. Multimodal measures (blood samples, pupillometry, behavioural consciousness assessments (Coma Recovery Scale-revised), actigraphy measures) will be acquired from baseline up to 1 week after the stimulation. EEG signal analysis will focus on the alpha bandwidth (8–13 Hz) using spectral and functional network analyses. Phone assessments at 3, 6 and 12 months post-tACS, will measure long-term functional recovery, quality of life and caregivers’ burden.Ethics and dissemination Ethical approval for this study has been granted by the Research Ethics Board of the CIUSSS du Nord-de-l’Île-de-Montréal (Project ID 2021–2279). The findings of this two-phase study will be submitted for publication in a peer-reviewed academic journal and submitted for presentation at conferences. The trial’s results will be published on a public trial registry database (ClinicalTrials.gov).Trial registration number NCT05833568.https://bmjopen.bmj.com/content/14/7/e078281.full |
| spellingShingle | David Williamson Francis Bernard Stefanie Blain-Moraes Caroline Arbour Virginie Williams Louis de Beaumont Catherine Duclos Béatrice P De Koninck Daphnee Brazeau Amelie A Deshaies Marie-Michele Briand Charlotte Maschke Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol BMJ Open |
| title | Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol |
| title_full | Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol |
| title_fullStr | Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol |
| title_full_unstemmed | Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol |
| title_short | Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol |
| title_sort | modulation of brain activity in brain injured patients with a disorder of consciousness in intensive care with repeated 10 hz transcranial alternating current stimulation tacs a randomised controlled trial protocol |
| url | https://bmjopen.bmj.com/content/14/7/e078281.full |
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