The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke

NCT03080454 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-04-05

Study results available
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Summary

The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker anodal DoubleStim treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal direct current stimulation) and of the median nerve at the peripheral wrist (pDCS-- peripheral direct current stimulation), can significantly reduce spasticity of the wrist and hand after stroke.

Conditions

  • Stroke
  • Cerebrovascular Accident (CVA)
  • Hemiparesis
  • Spasticity as Sequela of Stroke
  • Muscle Spasticity
  • Upper Extremity Paralysis

Interventions

DEVICE

sham Doublestim

PathMaker MyoRegulator device

DEVICE

anodal Doublestim

PathMaker MyoRegulator device

Sponsors & Collaborators

  • PathMaker Neurosystems Inc.

    collaborator INDUSTRY
  • Dr. Zaghloul Ahmed

    collaborator UNKNOWN
  • Northwell Health

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-03-31
Completion
2018-03-31

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 NCT03080454 on ClinicalTrials.gov