Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.

Study Overview
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Brief Summary
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Functional and structural magnetic resonance imaging (MRI) will be used to investigate neural correlates of bihemispheric transcranial direct current stimulation (tDCS) associated with upper limb rehabilitation in chronic stroke patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individualized rehabilitation. Neuroimage will be employed before and after the intervention to investigate neural correlates of expected changes in motor function.

Official Title
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Neuroplasticity Following Bihemispheric Transcranial Direct Current Stimulation and Motor Training in Chronic Stroke Patients.

Conditions
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Stroke

Intervention / Treatment
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* Device: tDCS + upper limb rehabilitation
* Device: Sham tDCS + upper limb rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic Stroke (> 12 months) Upper limb sensorimotor sequelae due to stroke affecting only one cerebral hemisphere The structural integrity of the corpus callosum sensorimotor Showing ability to perform some movement with the paretic upper limb: at least minimal active mobility of the wrist and two fingers of the paretic hand. Score ≥ 18 at Folstein Mini-Mental State Examination Exclusion Criteria: Score ≥ 4 at Ashworth Scale MRI or tDCS contraindications (cardiac pacemakers; implanted medication pumps; cochlear, or eye implants; craniotomy, skin lesions at the site of stimulation; surgical clips in or near the brain; claustrophobia, history of seizures, permanent makeup or tattoos with metallic dyes…) Prior neurological diseases Hemodynamic instability Pregnancy Traumatic or orthopedic lesion limiting the range of upper limb motion Severe comprehension deficits, apraxia or neglect that would interfere with performing the study tasks Score > 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS<br>Bihemispheric tDCS will be applied. The anode will be placed on the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. After stimulation, individual and intensive upper limb rehabilitation will be performed. | Device: tDCS + upper limb rehabilitation<br>* Stimulation will be applied for 20 minutes by a DC stimulator (NeuroConn, Germany). During each stimulation section, a pair of saline-soaked sponge electrodes (surface 24 cm²) will be placed over C3 and C4, according to the International 10-20 EEG system. Stimulation intensity will be 2 mA with current ramping up and down of 10 seconds each. The stimulation will be followed by 40 minutes of upper limb rehabilitation. Experimental sessions will be repeated five times per week to complete 10 sessions.<br>|
| Sham Comparator: Control<br>Bihemispheric sham tDCS will be applied. The anode will be placed on the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. After sham stimulation, individual and intensive upper limb rehabilitation will be performed. | Device: Sham tDCS + upper limb rehabilitation<br>* Sham stimulation will be applied for 20 minutes by a DC stimulator (NeuroConn, Germany). During each sham stimulation section, a pair of saline-soaked sponge electrodes (surface 24 cm²) will be placed over C3 and C4, according to the International 10-20 EEG system. The anode will be placed to the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. Sham tDCS will be performed by ramping current flow for the first 10 seconds of stimulation, but switching the stimulator off automatically after 30 seconds. The sham stimulation will be followed by 40 minutes of upper limb rehabilitation. Experimental sessions will be repeated five times per week to complete 10 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related changes in functional magnetic resonance imaging | Brain functional changes from baseline to post-treatment | pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment) | 
| Treatment-related changes in white matter | Brain structural (white matter) changes from baseline to post-treatment | pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fugl-Meyer assessment of paretic upper limb motor function | Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment, 30 and 90 days later (follow up). | pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment); 30 days follow up (30 days after completing treatment) and 90 days follow up (90 days after completing treatment) | 
| Changes in Jebsen-Taylor Hand Function Test scores | Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment and in subsequent follow-up | pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days | 
| Changes in Stroke Impact Scale scores | Stroke Impact Scale scores changes from baseline to post-treatment and in subsequent follow-up | pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke Rehabilitation, Transcranial Direct Current Stimulation, Neuroimaging, Neuronal Plasticity