Back to results

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

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

anodal tDCS (device) Eldith DC-Stimulator

Sham tDCS

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, transcranial direct current stimulation (tDCS), motor function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre de Lay-Saint-Christophe-Institut Régional de Médecine Physique et de Réadaptation
Hospices Civils de Lyon- Hôpital Henry Gabrielle-Service de Médecine Physique et Réadaptation

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham tDCS and motor training: sham comparator

Anodal tDCS and motor training: experimental

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Modified Ashworth Scale

We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

Testing motor MRC

We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

Full Information

NCT ID

NCT01500564

First Posted

December 22, 2011

Last Updated

January 30, 2018

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT01500564

Brief Title

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

Acronym

ReSTIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 2, 2012 (Actual)

Primary Completion Date

July 31, 2015 (Actual)

Study Completion Date

July 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, transcranial direct current stimulation (tDCS), motor function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sham tDCS and motor training: sham comparator

Arm Type

Sham Comparator

Arm Description

Arm Title

Anodal tDCS and motor training: experimental

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

anodal tDCS (device) Eldith DC-Stimulator

Other Intervention Name(s)

Eldith DC-Stimulator (CE certified)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Intervention Description

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).

Primary Outcome Measure Information:

Title

Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke

Description

Main primary outcome is change in score between the baseline session score and day 32.

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.

Secondary Outcome Measure Information:

Title

Functional independence scale (MIF)

Description

We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

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.

Title

Motor Activity Log (MAL)

Description

We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

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.

Title

Jebsen Taylor Hand function test (JTT)

Description

We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

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.

Title

Box and block test (BBT)

Description

We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

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.

Title

Modified Ashworth Scale

Description

We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

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.

Title

Testing motor MRC

Description

We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sophie JACQUIN-COURTOIS, MD

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de Lay-Saint-Christophe-Institut Régional de Médecine Physique et de Réadaptation

City

Lay Saint Christophe

ZIP/Postal Code

54690

Country

France

Facility Name

Hospices Civils de Lyon- Hôpital Henry Gabrielle-Service de Médecine Physique et Réadaptation

City

Saint Genis Laval

ZIP/Postal Code

69235

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

33175411

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs