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Completed

NCT Number: NCT03956407

Repetitive Nerve Stimulation to Improve Recovery After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suprathreshold repetitive peripheral sensory stimulation

Device

Suprathreshold repetitive peripheral sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For suprathreshold stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.

Subthreshold repetitive sensory stimulation

Device

Subthreshold repetitive sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For subthreshold stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required.

Primary outcomes

  1. Change in Jebsen-Taylor Test

    Time frame: Immediately after one session of intervention

    Test of upper limb dexterity

Secondary outcomes

  1. Change in lateral pinch strength

    Time frame: Immediately after one session of intervention

    Pinch strength measured with dynamometer

  2. Change in gamma-aminobutyric acid levels in primary motor cortex

    Time frame: Immediately after one session of intervention

    Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy

  3. Change in brain perfusion

    Time frame: Immediately after one session of intervention

    Brain perfusion measured with magnetic resonance imaging - arterial spin labeling

  4. Change in grasp strength

    Time frame: Immediately after one session of intervention

    Grasp strength measured with dynamometer

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Comparison Between Mechanisms Underlying Effects of Repetitive Peripheral Nerve Stimulation on Upper Limb Motor Performance in the Subacute and Chronic Phases After Stroke

Acronym: RESTORES

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 20, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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