CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
sham Doublestim +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03080454
NCT03080454Phase 2Completed
CompareCT.gov

The Effect of Treatment With the PathMaker Myoregulator Neuromodulation System Incorporating Trans-spinal Direct Current Stimulation (tsDCS) in Patients With Severe Hand Spasticity After Stroke

Northwell Health·interventional·Posted Mar 15, 2017·Updated Apr 5, 2021

In Brief

A Phase 2 clinical trial evaluating sham Doublestim and anodal Doublestim for Stroke and 5 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Cerebrovascular Accident (CVA), Hemiparesis, Spasticity as Sequela of Stroke, Muscle Spasticity, Upper Extremity Paralysis
CountriesUnited States
CollaboratorsPathMaker Neurosystems Inc., Dr. Zaghloul Ahmed

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 15, 2017
Enrollment StartSep 1, 2016
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.3 years ago

Interventions

sham Doublestimdevice

PathMaker MyoRegulator device

anodal Doublestimdevice

PathMaker MyoRegulator device