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Peripheral Nerve Stimulation and Motor Training in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PNS
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active PNS

Sham PNS

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Motor Activity Log
This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Active range of motion of wrist extension in the paretic side
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Active range of motion of wrist flexion in the paretic side
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Grasp force in the paretic side
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Grip force in the paretic side
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Fugl-Meyer Assessment of Sensorimotor Recovery
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Barthel Index
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Stroke Impact Scale
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Beck Depression Inventory-short Form
This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Wolf Motor Function Test
This scale as a secondary outcome will be evaluated before the intervention and 3, 10 and 18 weeks after the beginning of the intervention.
Modified Ashworth Scale
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks
Minimal Clinically Important Difference - Wolf Motor Function Test - time
This outcome will be evaluated at 6, 10 and 18 weeks
Minimal Clinically Important Difference - Wolf Motor Function Test - Functional Ability Scale
This outcome will be evaluated at 6, 10 and 18 weeks

Full Information

First Posted
December 29, 2015
Last Updated
July 21, 2021
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação Faculdade de Medicina, National Institute of Neurological Disorders and Stroke (NINDS), The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02658578
Brief Title
Peripheral Nerve Stimulation and Motor Training in Stroke
Official Title
Peripheral Nerve Stimulation and Motor Training to Enhance Hand Function After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação Faculdade de Medicina, National Institute of Neurological Disorders and Stroke (NINDS), The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The objective of this protocol is to determine whether a neuromodulation intervention associated with functional electrical stimulation, when combined with task-specific training over several sessions, decreases upper limb motor disability, motor impairment, overall disability and improves quality of life compared to the sham intervention and functional electrical stimulation. The interventions will consist of three sessions per week, over six weeks, of outpatient functional electrical stimulation of the paretic wrist and task-specific training. In each session, either active peripheral nerve stimulation (PNS) or sham PNS will be applied. Before the first session, patients will be familiarized with the procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active PNS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham PNS
Arm Type
Placebo Comparator
Arm Description
In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.
Intervention Type
Procedure
Intervention Name(s)
PNS
Other Intervention Name(s)
Peripheral Nerve Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
The primary outcome will be evaluated before the intervention and 6 weeks after the beginning of the intervention.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Motor Activity Log
Description
This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Active range of motion of wrist extension in the paretic side
Description
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Active range of motion of wrist flexion in the paretic side
Description
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Grasp force in the paretic side
Description
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Grip force in the paretic side
Description
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Fugl-Meyer Assessment of Sensorimotor Recovery
Description
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Barthel Index
Description
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Stroke Impact Scale
Description
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Beck Depression Inventory-short Form
Description
This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Wolf Motor Function Test
Description
This scale as a secondary outcome will be evaluated before the intervention and 3, 10 and 18 weeks after the beginning of the intervention.
Time Frame
18 weeks
Title
Modified Ashworth Scale
Description
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks
Time Frame
18 weeks
Title
Minimal Clinically Important Difference - Wolf Motor Function Test - time
Description
This outcome will be evaluated at 6, 10 and 18 weeks
Time Frame
18 weeks
Title
Minimal Clinically Important Difference - Wolf Motor Function Test - Functional Ability Scale
Description
This outcome will be evaluated at 6, 10 and 18 weeks
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Conforto, MD PhD
Organizational Affiliation
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/ Fundação Faculdade de Medicina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
34587830
Citation
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.
Results Reference
derived
PubMed Identifier
32269549
Citation
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.
Results Reference
derived

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Peripheral Nerve Stimulation and Motor Training in Stroke

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