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

NCT01500564 | Completed DMC

• 1 other identifier: 2010.635
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Functional independence scale (MIF)

  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)

  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)

  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)

  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

  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.

Study Arms (2)

Sham tDCS and motor training: sham comparator

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

Anodal tDCS and motor training: experimental

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

Interventions

anodal tDCS (device) Eldith DC-Stimulator 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.

Also known as: Eldith DC-Stimulator (CE certified)

Anodal tDCS and motor training: experimental

Sham tDCS 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).

Sham tDCS and motor training: sham comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

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

Lay-Saint-Christophe, 54690, France

Location

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

Saint-Genis-Laval, 69235, France

Location

Related Publications (1)

• 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.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sophie JACQUIN-COURTOIS, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: January 2, 2012
• Primary Completion: July 31, 2015
• Study Completion: July 31, 2015
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

FR (2)