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Peripheral Nerve Stimulation and Motor Training in Stroke

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ClinicalTrials.gov Identifier: NCT02658578
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Stroke Procedure: PNS

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peripheral Nerve Stimulation and Motor Training to Enhance Hand Function After Stroke
Study Start Date : February 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Active PNS
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
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.
Other Name: Peripheral Nerve Stimulation
Placebo Comparator: Sham PNS
In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.
Procedure: PNS
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.
Other Name: Peripheral Nerve Stimulation


Outcome Measures

Primary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: 6 weeks ]
    The primary outcome will be evaluated before the intervention and 6 weeks after the beginning of the intervention.


Secondary Outcome Measures :
  1. Motor Activity Log [ Time Frame: 18 weeks ]
    This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  2. Active range of motion of wrist extension in the paretic side [ Time Frame: 18 weeks ]
    This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  3. Active range of motion of wrist flexion in the paretic side [ Time Frame: 18 weeks ]
    This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  4. Grasp force in the paretic side [ Time Frame: 18 weeks ]
    This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  5. Grip force in the paretic side [ Time Frame: 18 weeks ]
    This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  6. Fugl-Meyer Assessment of Sensorimotor Recovery [ Time Frame: 18 weeks ]
    This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  7. Barthel Index [ Time Frame: 18 weeks ]
    This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  8. Stroke Impact Scale [ Time Frame: 18 weeks ]
    This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  9. Beck Depression Inventory-short Form [ Time Frame: 18 weeks ]
    This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.

  10. Wolf Motor Function Test [ Time Frame: 18 weeks ]
    This scale as a secondary outcome will be evaluated before the intervention and 3, 10 and 18 weeks after the beginning of the intervention.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658578


Contacts
Contact: Rafael Luccas +55-11-26617955 lab.neuro@outlook.com
Contact: Adriana Conforto, MD PhD +55-11-26617955 adriana.conforto@hc.fm.usp.br

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina Recruiting
São Paulo, SP, Brazil, 05403000
Contact: Rafael Luccas    +55-11-26617955    lab.neuro@outlook.com   
Contact: Adriana Conforto, MD, PhD       adriana.conforto@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação Faculdade de Medicina
National Institute of Neurological Disorders and Stroke (NINDS)
The Cleveland Clinic
Investigators
Principal Investigator: Adriana Conforto, MD PhD Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/ Fundação Faculdade de Medicina
More Information

Responsible Party: Adriana Bastos Conforto, Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02658578     History of Changes
Other Study ID Numbers: 0546/2011
R01NS076348 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases