Repetitive Nerve Stimulation to Improve Recovery After Stroke (RESTORES)

Hospital Israelita Albert Einstein

Status: Unknown

Conditions: Stroke

Treatments: Device: Sham Repetitive peripheral nerve stimulation; Device: Repetitive peripheral nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03956407

3019629

Details and patient eligibility

About

Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral electrical stimulation (RPES) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPES on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic or hemorrhagic stroke confirmed by computed tomography or magnetic resonance imaging, between 7 days - 3 months before enrollment (subacute phase), and at least 6 months (chronic phase).
• Ability to perform at least 4 of 7 tasks performed in daily life that is part of the Jebsen-Taylor Test

Exclusion criteria

• Anesthesia of the paretic hand.
• Lesions affecting the motor cortex (hand area).
• Lesions affecting cerebellum, or cerebellar pathways in the brainstem.
• Severe spasticity at the paretic elbow, fist or fingers, defined with a score larger than 3 on the Modified Ashworth Scale.
• Neurological diseases such as Parkinson disease or chronic uncontrolled chronic disease such as cancer or cardiac insufficiency.
• Elbow pain or join deformity in the paretic limb.
• Pregnancy.
• Uncontrolled psychiatric disease.
• Aphasia or severe cognitive deficit.
• Inability to provide consent.
• Inability to attend the experimental sessions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 4 patient groups

Active, subacute stroke

Active Comparator group

Description:

Repetitive peripheral electrical stimulation (RPES) + Motor Training. Active RPES will be administered for 2 hours. After active session of RPES, the patient will receive motor training.

Treatment:

Device: Repetitive peripheral nerve stimulation

Sham, subacute stroke

Sham Comparator group

Description:

Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training

Treatment:

Device: Sham Repetitive peripheral nerve stimulation

Active, chronic stroke

Active Comparator group

Description:

Repetitive peripheral electrical stimulation (RPES) + Motor Training. Active RPES will be administered for 2 hours. After active session of RPES, the patient will receive motor training.

Treatment:

Device: Repetitive peripheral nerve stimulation

Sham, chronic stroke

Sham Comparator group

Description:

Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training

Treatment:

Device: Sham Repetitive peripheral nerve stimulation