Clinical trial NCT01500564: Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol): ReSTIM
Official title: Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
transcranial direct current stimulation (tDCS)
motor function
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-12-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke
timeFrame: 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:
measure: Functional independence scale (MIF)
timeFrame: 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.
measure: Motor Activity Log (MAL)
timeFrame: 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.
measure: Jebsen Taylor Hand function test (JTT)
timeFrame: 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.
measure: Box and block test (BBT)
timeFrame: 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.
measure: Modified Ashworth Scale
timeFrame: 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.
measure: Testing motor MRC
timeFrame: 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.
Other outcomes:
Locations:
city: Lay Saint Christophe
country: France
facility: Centre de Lay-Saint-Christophe-Institut Régional de Médecine Physique et de Réadaptation
city: Saint Genis Laval
country: France
facility: Hospices Civils de Lyon- Hôpital Henry Gabrielle-Service de Médecine Physique et Réadaptation
Study officials:
affiliation: Hospices Civils de Lyon
name: Sophie JACQUIN-COURTOIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.