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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Sham tDCS; Device: anodal tDCS (device) Eldith DC-Stimulator

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lay Saint Christophe, France, 54690
    • Centre de Lay-Saint-Christophe-Institut Régional de Médecine Physique et de Réadaptation
  • Saint Genis Laval, France, 69235
    • Hospices Civils de Lyon- Hôpital Henry Gabrielle-Service de Médecine Physique et Réadaptation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Eldith DC-Stimulator (CE certified)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke	Main primary outcome is change in score between the baseline session score and day 32.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional independence scale (MIF)	We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.	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.
Motor Activity Log (MAL)	We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.	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.
Jebsen Taylor Hand function test (JTT)	We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.	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.
Box and block test (BBT)	We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.	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.
Modified Ashworth Scale	We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.	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.
Testing motor MRC	We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.	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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sophie JACQUIN-COURTOIS, MD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2012
• Primary Completion (Actual): July 31, 2015
• Study Completion (Actual): July 31, 2015

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 27, 2011
• First Posted (Estimate): December 28, 2011

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Stroke; transcranial direct current stimulation (tDCS); motor function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2010.635