Using brain stimulation to improve awareness in patients with minimally conscious state
Closed-loop Application of tDCS to Promote Responsiveness of Patients in MCS
NA · University of Liege · NCT03810079
This study is testing if a special brain stimulation technique can help improve awareness in patients who are minimally conscious by timing the treatment during moments when they are more alert.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 16 Years to 75 Years |
| Sex | All |
| Sponsor | University of Liege (other) |
| Locations | 1 site (Liege) |
| Trial ID | NCT03810079 on ClinicalTrials.gov |
What this trial studies
This research tests a closed-loop system that utilizes EEG-arousal measures to determine the optimal timing for applying transcranial direct current stimulation (tDCS) in patients diagnosed with minimally conscious state (MCS). The study aims to evaluate whether tDCS is more effective during periods of high vigilance compared to low vigilance states. It also investigates differences in EEG patterns following active versus sham tDCS and profiles of responders versus non-responders based on various clinical and neuroimaging factors. The goal is to enhance conscious awareness in patients who are minimally conscious through targeted neuromodulation techniques.
Who should consider this trial
Good fit: Ideal candidates include adults aged 16 to 75 who have a stable diagnosis of minimally conscious state and are more than 28 days post-injury.
Not a fit: Patients with severe medical conditions affecting EEG activity or those with certain implants or recent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the level of conscious awareness in patients with minimally conscious state.
How similar studies have performed: Previous studies have shown some success with tDCS in patients with disorders of consciousness, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CNS medication stable for at least a week, * Stable diagnosis of MCS (no diagnosis change based on 2 CRS-R performed within 1 week). * Adult (16 years old - 75 years old) * \> 28 days post injury Exclusion Criteria: * open craniotomies, * VPS under the stimulated area (prefrontal cortex), * pacemaker, * metallic cerebral implant, according to safety criteria for transcranial electric stimulation, * severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).
Where this trial is running
Liege
- University Hospital of Liege — Liege, Belgium (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Minimally Conscious State, transcranial direct current stimulation, minimally conscious state, disorders of consciousness, non invasive brain stimulation, neuromodulation