Repetitive Nerve Stimulation to Improve Recovery After Stroke
- Conditions
- Stroke
- Interventions
- Device: Sham Repetitive peripheral nerve stimulationDevice: Repetitive peripheral nerve stimulation
- Registration Number
- NCT03956407
- Lead Sponsor
- Hospital Israelita Albert Einstein
- Brief Summary
Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) 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 RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham, chronic stroke Sham Repetitive peripheral nerve stimulation Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training Active, subacute stroke Repetitive peripheral nerve stimulation 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. Active, chronic stroke Repetitive peripheral nerve stimulation 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. Sham, subacute stroke Sham Repetitive peripheral nerve stimulation Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training
- Primary Outcome Measures
Name Time Method Change in Jebsen-Taylor Test Immediately after one session of intervention Test of upper limb dexterity
- Secondary Outcome Measures
Name Time Method Change in lateral pinch strength Immediately after one session of intervention Pinch strength measured with dynamometer
Change in gamma-aminobutyric acid levels in primary motor cortex Immediately after one session of intervention Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy
Change in brain perfusion Immediately after one session of intervention Brain perfusion measured with magnetic resonance imaging - arterial spin labeling
Change in grasp strength Immediately after one session of intervention Grasp strength measured with dynamometer
Trial Locations
- Locations (1)
Hospital São Rafael
🇧🇷Salvador, BA, Brazil