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Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity

NCT04742257 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-08-15

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind (patient and evaluator), sham-controlled study to be conducted in stroke patients with upper-extremity spasticity. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active- versus sham-treated patients after 5 consecutive days of treatment. The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation for the treatment of muscle spasticity.

Conditions

Interventions

DEVICE

MyoRegulator® device

Trans-spinal DCS paired with peripheral DCS

Sponsors & Collaborators

  • Spaulding Rehabilitation Hospital

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • PathMaker Neurosystems Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-04
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742257 on ClinicalTrials.gov