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

Stroke Clinical Trial

— ReSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500564
• Other study ID #: 2010.635
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: January 30, 2018
• Start date: January 2, 2012
• Est. completion date: July 31, 2015

Study information

• Verified date: January 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 31, 2015
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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).

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.