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Repetitive Nerve Stimulation to Improve Recovery After Stroke (RESTORES)

H

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

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

Trial contacts and locations

2

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Central trial contact

Larissa Servinsckins; Adriana Conforto

Data sourced from clinicaltrials.gov

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