Trials / Unknown
UnknownNCT03007784
Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown. This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.
Detailed description
This study will use a cross-over double-blind design with each patient receiving both current intensities in a randomized order during 4 weeks (2 weeks for each tDCS intensity, totalizing a number of 10X2 stimulation sessions of 20 minutes each).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | transcranial direct current stimulation (tDCS) / Comparison of current intensities |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2021-01-01
- First posted
- 2017-01-02
- Last updated
- 2017-01-18
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03007784. Inclusion in this directory is not an endorsement.