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

NCT ID: NCT01500564

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-02
• Study Completion Date: 2015-07-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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).

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

Group Type: EXPERIMENTAL

anodal tDCS (device) Eldith DC-Stimulator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

Eldith DC-Stimulator (CE certified)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie JACQUIN-COURTOIS, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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

Lay-Saint-Christophe, , France

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

Saint-Genis-Laval, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33175411 (View on PubMed)

Other Identifiers

2010.635

Identifier Type: -

Identifier Source: org_study_id