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tDCS on Precuneus in MCS: Repeated Stimulations

Primary Purpose

Patients in Minimally Conscious State After a Severe Brain Injury

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Hangzhou Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients in Minimally Conscious State After a Severe Brain Injury focused on measuring disorders of consciousness, minimally conscious state, traumatic brain injury, stroke, transcranial direct current stimulation

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    anodal stimulation

    sham stimulation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 2, 2016
    Last Updated
    March 7, 2016
    Sponsor
    Hangzhou Normal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02702362
    Brief Title
    tDCS on Precuneus in MCS: Repeated Stimulations
    Official Title
    Repeated Stimulation of the Precuneus in Chronic Patients in Minimally Conscious State: a Placebo-controlled Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hangzhou Normal University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patients in Minimally Conscious State After a Severe Brain Injury
    Keywords
    disorders of consciousness, minimally conscious state, traumatic brain injury, stroke, transcranial direct current stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    anodal stimulation
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    sham stimulation
    Arm Type
    Sham Comparator
    Arm Description
    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 Type
    Device
    Intervention Name(s)
    transcranial direct current stimulation
    Intervention Description
    anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.
    Primary Outcome Measure Information:
    Title
    Change in the CRS-R total score
    Description
    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
    Time Frame
    After each stimulation and 5 days later for anodal and sham sessions (total: 1 month)
    Secondary Outcome Measure Information:
    Title
    Influence of the time since insult
    Description
    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.
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

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    tDCS on Precuneus in MCS: Repeated Stimulations

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