Peripheral Nerve Stimulation and Motor Training in Stroke

• ClinicalTrials.gov Identifier: NCT02658578
• Recruitment Status: Active, not recruiting
• First Posted: January 20, 2016
• Last Update Posted: November 5, 2020
• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação Faculdade de Medicina; National Institute of Neurological Disorders and Stroke (NINDS); The Cleveland Clinic
• Information provided by (Responsible Party): Adriana Bastos Conforto, University of Sao Paulo General Hospital

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	Phase
Stroke	Procedure: PNS	Not Applicable

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)
• Actual Enrollment: 38 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
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: March 2020
• Estimated Study Completion Date: March 2021

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.
11. Modified Ashworth Scale [ Time Frame: 18 weeks ]
    This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks
12. Minimal Clinically Important Difference - Wolf Motor Function Test - time [ Time Frame: 18 weeks ]
    This outcome will be evaluated at 6, 10 and 18 weeks
13. Minimal Clinically Important Difference - Wolf Motor Function Test - Functional Ability Scale [ Time Frame: 18 weeks ]
    This outcome will be evaluated at 6, 10 and 18 weeks

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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.
• Lesions that affect the cerebellum or cerebelar/vestibular pathways in the brainstem

Contacts and Locations

Locations

Brazil

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

São Paulo, SP, Brazil, 05403000

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Adriana Bastos Conforto, Professor, University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT02658578
• Other Study ID Numbers: 0546/2011; R01NS076348 ( U.S. NIH Grant/Contract )
• First Posted: January 20, 2016
• Last Update Posted: November 5, 2020
• Last Verified: November 2020

Additional relevant MeSH terms:

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