tDCS on Precuneus in MCS: Repeated Stimulations
Repeated Stimulation of the Precuneus in Chronic Patients in Minimally Conscious State: a Placebo-controlled Randomized Clinical Trial
1 other identifier
interventional
33
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 2, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedMarch 8, 2016
March 1, 2016
8 months
March 2, 2016
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the CRS-R total score
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
After each stimulation and 5 days later for anodal and sham sessions (total: 1 month)
Secondary Outcomes (1)
Influence of the time since insult
one month
Study Arms (2)
anodal stimulation
ACTIVE COMPARATORPatients 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.
sham stimulation
SHAM COMPARATORPatients 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.
Interventions
anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- graduate student
Study Record Dates
First Submitted
March 2, 2016
First Posted
March 8, 2016
Study Start
December 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
March 8, 2016
Record last verified: 2016-03