tDCS on Precuneus in MCS: Repeated Stimulations

Patients in Minimally Conscious State After a Severe Brain Injury Clinical Trial

Official title:

Repeated Stimulation of the Precuneus in Chronic Patients in Minimally Conscious State: a Placebo-controlled Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702362
• Other study ID #: 2016/302/A
• Status: Completed
• Phase: Phase 2
• First received: March 2, 2016
• Last updated: March 7, 2016
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Patients in Minimally Conscious State After a Severe Brain Injury
• Persistent Vegetative State

Intervention

Device:
• transcranial direct current stimulation
anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Influence of the time since insult	Influence of the time since insult of the results. Researchers expected that the longer a patient is in MCS, the lower is his/her improvement after the tDCS session.	one month	Yes