Repetitive Nerve Stimulation to Improve Recovery After Stroke

NCT03956407 | Completed DMC

• 1 other identifier: 3019629
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Rehabilitation; Neuromodulation; Peripheral stimulation; Motor function

Outcome Measures

Primary Outcomes (1)

• Change in Jebsen-Taylor Test

  Test of upper limb dexterity

  Immediately after one session of intervention

Secondary Outcomes (4)

• Change in lateral pinch strength

  Immediately after one session of intervention

• Change in gamma-aminobutyric acid levels in primary motor cortex

  Immediately after one session of intervention

• Change in brain perfusion

  Immediately after one session of intervention

• Change in grasp strength

  Immediately after one session of intervention

Study Arms (4)

Suprathreshold, subacute stroke

EXPERIMENTAL

Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPES, the patient will receive motor training.

Device: Suprathreshold repetitive peripheral sensory stimulation

Subthreshold, subacute stroke

OTHER

Other: Subthreshold RPSS + Motor Training. Subthreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training

Device: Subthreshold repetitive sensory stimulation

Suprathreshold, chronic stroke

EXPERIMENTAL

Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training.

Device: Suprathreshold repetitive peripheral sensory stimulation

Subthreshold, chronic stroke

OTHER

Other: Subthreshold RPSS + Motor Training. RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training

Device: Subthreshold repetitive sensory stimulation

Interventions

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.

Suprathreshold, chronic stroke; Suprathreshold, subacute stroke

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.

Subthreshold, chronic stroke; Subthreshold, subacute stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Related Publications (1)

• Kroth JB, Handfas B, Rodrigues G, Zepeda F, Oliveira MA, Wang DJJ, de Azevedo Neto RM, Silva GS, Amaro E Jr, Sorinola IO, Conforto AB. Effects of Repetitive Peripheral Sensory Stimulation in the Subacute and Chronic Phases After Stroke: Study Protocol for a Pilot Randomized Trial. Front Neurol. 2022 Feb 16;13:779128. doi: 10.3389/fneur.2022.779128. eCollection 2022.

  PMID: 35250807 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: An amendment for performance of a minimization procedure in order to enhance the probability of comparable characteristics between the groups was approved. The researcher responsible for minimization is not involved in data collection or analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: December 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

BR (1)