Peripheral Nerve Stimulation and Motor Training in Stroke

NCT02658578 | Completed DMC

• 2 other identifiers: 0546/2011R01NS076348
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. The investigators will non-invasively stimulate peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of motor training in patients in the chronic stage after stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Wolf Motor Function Test

  The primary outcome will be evaluated before the intervention and 6 weeks after the beginning of the intervention.

  6 weeks

Secondary Outcomes (13)

• Motor Activity Log

  18 weeks

• Active range of motion of wrist extension in the paretic side

  18 weeks

• Active range of motion of wrist flexion in the paretic side

  18 weeks

• Grasp force in the paretic side

  18 weeks

• Grip force in the paretic side

  18 weeks

Study Arms (2)

Active PNS

ACTIVE COMPARATOR

Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.

Procedure: PNS

Sham PNS

PLACEBO COMPARATOR

In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.

Procedure: PNS

Interventions

PNS PROCEDURE

Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.

Also known as: Peripheral Nerve Stimulation

Active PNS; Sham PNS

Eligibility Criteria

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

You may qualify if:

• Age, 18 years or older;
• Ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
• Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function);
• Ability to provide written Informed Consent (patient or legal representative);
• Ability to comply with the schedule of interventions and evaluations in the protocol.

You may not qualify if:

• Lack of ability to voluntarily activate any active range of wrist extension;
• Anesthesia of the paretic hand;
• Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of \>3 on the Modified Ashworth Spasticity Scale;
• Active joint deformity;
• Uncontrolled medical problems such as end-stage cancer or renal disease;
• Pregnancy;
• Seizures, if current use of drugs that may decrease seizure threshold such as tryciclic antidepressants;
• Pacemakers;
• Other neurological disorders such as Parkinson's disease;
• Psychiatric illness including severe depression;
• Aphasia or serious cognitive deficits that preclude comprehension of the experimental protocol or ability to provide consent;
• Treatment of upper limb spasticity with botulinum toxin within the past three months.
• Lesions that affect the cerebellum or cerebelar/vestibular pathways in the brainstem

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação Faculdade de Medicina: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (2)

• Conforto AB, Machado AG, Ribeiro NHV, Plow EB, Liew SL, da Costa Leite C, Zavaliangos-Petropulu A, Menezes I, Dos Anjos SM, Luccas R, Peckham PH, Cohen LG. Repetitive Peripheral Sensory Stimulation as an Add-On Intervention for Upper Limb Rehabilitation in Stroke: A Randomized Trial. Neurorehabil Neural Repair. 2021 Dec;35(12):1059-1064. doi: 10.1177/15459683211046259. Epub 2021 Sep 29.

  PMID: 34587830 DERIVED

• Conforto AB, Machado AG, Menezes I, Ribeiro NHV, Luccas R, Pires DS, Leite CDC, Plow EB, Cohen LG. Treatment of Upper Limb Paresis With Repetitive Peripheral Nerve Sensory Stimulation and Motor Training: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2020 Mar 25;11:196. doi: 10.3389/fneur.2020.00196. eCollection 2020.

  PMID: 32269549 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Adriana Conforto, MD PhD

  Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/ Fundação Faculdade de Medicina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 20, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: July 22, 2021

Record last verified: 2020-11

Locations

BR (1)