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
  Purpose

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.


Condition Intervention
Stroke
Device: anodal tDCS (device) Eldith DC-Stimulator
Device: Sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
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
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500564

Contacts
Contact: Sophie JACQUIN-COURTOIS, MD + 33 4 78 86 52 68 sophie.courtois@chu-lyon.fr

Locations
France
Centre de Lay-Saint-Christophe-Institut Régional de Médecine Physique et de Réadaptation Recruiting
Lay Saint Christophe, France, 54690
Contact: Matthieu KANDEL, MD    + 33 3 83 22 22 31    matthieukandel@yahoo.fr   
Principal Investigator: Matthieu KANDEL, MD         
Hospices Civils de Lyon- Hôpital Henry Gabrielle-Service de Médecine Physique et Réadaptation Recruiting
Saint Genis Laval, France, 69235
Contact: Sophie JACQUIN-COURTOIS, MD    + 33 4 78 86 52 68    sophie.courtois@chu-lyon.fr   
Principal Investigator: Sophie JACQUIN-COURTOIS, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sophie JACQUIN-COURTOIS, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01500564     History of Changes
Other Study ID Numbers: 2010.635
Study First Received: December 22, 2011
Last Updated: November 28, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Stroke
transcranial direct current stimulation (tDCS)
motor function

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014