Neuroplasticity Following Bihemispheric Transcranial Direct Current Stimulation and Motor Training in Chronic Stroke Patients.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- D'Or Institute for Research and Education
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Treatment-related changes in functional magnetic resonance imaging
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Treatment-related changes in functional magnetic resonance imaging
Time Frame: pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)
Brain functional changes from baseline to post-treatment
Treatment-related changes in white matter
Time Frame: pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)
Brain structural (white matter) changes from baseline to post-treatment
Secondary Outcomes
- Changes in Jebsen-Taylor Hand Function Test scores(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(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 Fugl-Meyer assessment of paretic upper limb motor function(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))