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

D'Or Institute for Research and Education

Status and phase: Unknown; Phase 2

Conditions: Stroke

Treatments: Device: Sham tDCS + upper limb rehabilitation; Device: tDCS + upper limb rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04195412

PRJ1913

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

tDCS

Experimental group

Description:

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.

Treatment:

Device: tDCS + upper limb rehabilitation

Control

Sham Comparator group

Description:

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.

Treatment:

Device: Sham tDCS + upper limb rehabilitation