Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol): ReSTIM

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01500564
First received: December 22, 2011
Last updated: November 28, 2013
Last verified: November 2013

December 22, 2011
November 28, 2013
December 2011
January 2015   (final data collection date for primary outcome measure)
Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke [ Time Frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later. ] [ Designated as safety issue: No ]
Main primary outcome is change in score between the baseline session score and day 32.
Same as current
Complete list of historical versions of study NCT01500564 on ClinicalTrials.gov Archive Site
  • Functional independence scale (MIF) [ Time Frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later. ] [ Designated as safety issue: No ]
    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
  • Motor Activity Log (MAL) [ Time Frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later. ] [ Designated as safety issue: No ]
    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
  • Jebsen Taylor Hand function test (JTT) [ Time Frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later. ] [ Designated as safety issue: No ]
    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
  • Box and block test (BBT) [ Time Frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later. ] [ Designated as safety issue: No ]
    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
  • Modified Ashworth Scale [ Time Frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later. ] [ Designated as safety issue: No ]
    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
  • Testing motor MRC [ Time Frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later. ] [ Designated as safety issue: No ]
    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
Same as current
Not Provided
Not Provided
 
Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol): ReSTIM
Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).

Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.

This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Device: anodal tDCS (device) Eldith DC-Stimulator
    tDCS applied to the motor cortex every day of two consecutive weeks (10 sessions) at 1 mA during 20 minutes. Conductive rubber covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 100 seconds.
    Other Name: Eldith DC-Stimulator (CE certified)
  • Device: Sham tDCS
    Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).
  • Sham Comparator: Sham tDCS and motor training: sham comparator

    Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).

    Intervention: placebo tDCS Other: Motor Training

    Intervention: Device: Sham tDCS
  • Experimental: Anodal tDCS and motor training: experimental

    Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).

    Interventions:

    • Device: anodal tDCS
    • Other: motor Training during physiotherapy
    Intervention: Device: anodal tDCS (device) Eldith DC-Stimulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All subjects must be between the ages of 18-90 and must not be pregnant.
  • Patients volunteer to participate in the study, with a written informed consent signed
  • Affiliation to a national health insurance program
  • First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report
  • Contralesional motor deficit
  • Lesion sparing primary motor cortex
  • Stroke onset >1 month and <6 months prior to study enrollment

Exclusion Criteria:

  • Coexistent major neurological or psychiatric disease as to decrease number of confounders
  • History of epilepsy before stroke (or episodes of seizures within the last six months)
  • Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
  • Subjects with global aphasia and deficits of comprehension
  • Excessive pain in any joint of the paretic extremity (VAS>4)
  • Contraindications to Tdcs : metal in the head, implanted brain medical devices
  • Coexistent major neurological or psychiatric disease as to decrease number of confounders
  • A history of significant alcohol or drug abuse in the prior 6 months
  • Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours
  • Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke
  • Pregnancy
Both
18 Years to 80 Years
No
Contact: Sophie JACQUIN-COURTOIS, MD + 33 4 78 86 52 68 sophie.courtois@chu-lyon.fr
France
 
NCT01500564
2010.635
Yes
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Sophie JACQUIN-COURTOIS, MD Hospices Civils de Lyon
Hospices Civils de Lyon
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP