Repeated Stimulation of the Precuneus in Chronic Patients in Minimally Conscious State: a Placebo-controlled Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Primary Endpoint
- Change in the CRS-R total score
Study Overview
Brief Summary
In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).
Detailed Description
Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the precuneus cortex for 5 consecutive days in chronic patients in MCS.
2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 5 days after the end of the sessions to assess the long term effect of the tDCS.
Researchers expected to see an improvement of the CRS-R total score at the end of the anodal session and that this improvement persists for 5 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •post comatose patients
- •patients in minimally conscious state
- •patients with stable condition
- •patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)
Exclusion Criteria
- •premorbid neurology antecedent
- •patients in coma or vegetative state
- •patients < 1 months after the acute brain injury
- •patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)
Arms & Interventions
anodal stimulation
Patients received anodal tDCS (on the precuneus ) every day for 5 days (tDCS of 2mA during 20minutes). A CRS-R is performed at baseline (before the first stimulation) and after each tDCS.
A final CRS-R is performed 5 days after the end of the session to assess the potential long term effects of the tDCS.
Intervention: transcranial direct current stimulation (Device)
sham stimulation
Patients received sham tDCS (5 secondes of stimulation) every day for 5 days. A CRS-R is performed at baseline (before the first stimulation) and after each tDCS. A final CRS-R is performed 5 days after the end of the session.
Intervention: transcranial direct current stimulation (Device)
Outcomes
Primary Outcomes
Change in the CRS-R total score
Time Frame: After each stimulation and 5 days later for anodal and sham sessions (total: 1 month)
Improvement of the CRS-R total score after the end of the anodal session and 5 days later but no change for the sham session
Secondary Outcomes
- Influence of the time since insult(one month)
Investigators
Wangshan Huang
graduate student
Hangzhou Normal University