Minimally Conscious State Clinical Trial
Official title:
Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness: a Randomized Double-blind Controlled Trial
NCT number | NCT04065386 |
Other study ID # | 2019/91 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 9, 2022 |
Est. completion date | December 2024 |
Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders of consciousness. Notably, a case reported improvement of level of consciousness using transcutaneous auricular vagal nerve stimulation in a patient in unresponsive wakefulness syndrome. Here we aim to assess the effects of transcutaneous auricular vagal nerve stimulation on post-coma patients with disorders of consciousness in a first randomized controlled trial. To measure these effects, behavioral (Coma recovery scale revised - CRS-R -primary outcome) and neuro-electrophysiological (electroencephalography - EEG - secondary outcome) data will be recorded in severely brain-injured patients with DOC.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Age = 18 years old - State of consciousness: unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) as defined by CRS-R performed during the screening period. - Cerebral damage of known etiology - Time since injury between 7 and 90 days - Intact skin at the ears - Consent given by the substitute decision maker Exclusion Criteria: - Anyone who is deemed medically unsuitable for this study as determined by a physician involved with the study (e.g. severe rythmic heart condition) - Previous history of neurological disorders - Documented pregnancy - Active implant (i.e. pacemaker) - Profound sedation such as one caused by general anaesthetics (e.g., propofol) or a combination of central acting sedatives (e.g., benzodiazepines, opioids) |
Country | Name | City | State |
---|---|---|---|
Belgium | Centre Hospitalier Universitaire de Liège | Liège | |
Belgium | Centre Neurologique William Lennox | Ottignies-Louvain-la-Neuve | Brabant Wallon |
Lead Sponsor | Collaborator |
---|---|
University of Liege |
Belgium,
Yakunina N, Kim SS, Nam EC. Optimization of Transcutaneous Vagus Nerve Stimulation Using Functional MRI. Neuromodulation. 2017 Apr;20(3):290-300. doi: 10.1111/ner.12541. Epub 2016 Nov 29. — View Citation
Yu YT, Yang Y, Wang LB, Fang JL, Chen YY, He JH, Rong PJ. Transcutaneous auricular vagus nerve stimulation in disorders of consciousness monitored by fMRI: The first case report. Brain Stimul. 2017 Mar - Apr;10(2):328-330. doi: 10.1016/j.brs.2016.12.004. Epub 2016 Dec 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in CRS-R total score and index score | Behavioral improvement measured by standardized scale. This scale is ranging from 0 to 23, highest score represents more signs of consciousness. The index score is ranging from 0 to 100. | Before the installation of the EEG equipment in the pre-stimulation period and 5 minutes after the post-stimulation resting state EEG (immediately after removing the equipment). | |
Secondary | Change in EEG | Improvement in cerebral activity (i.e. power spectrum in the alpha and theta band and connectivity) as measured by EEG | 15 min before the stimulation period and 15 min after the stimulation period. |
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