CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 199 enrolled
Drug / intervention
NBS-guided rTMS +2 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/NCT02089464
NCT02089464N/ACompleted

Pivotal Phase III, Prospective, Multicenter, Double Blinded, Randomized, Sham Controlled Trial to Determine the Therapeutic Effects of Navigation Guided 1 Hz rTMS Administered to the Contralesional Hemisphere as Adjuvant to Task Oriented Rehabilitation in Patients With Ischemic or Hemorrhagic Stroke

Nexstim Ltd·interventional·Posted Mar 17, 2014·Updated Sep 1, 2020

In Brief

A clinical study evaluating NBS-guided rTMS, Sham rTMS, and 1 other intervention for Stroke. Completed, enrolled 199 participants across 12 sites.

Detailed Summary

A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 17, 2014
Enrollment StartApr 1, 2014
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.3 years ago

Interventions

NBS-guided rTMSdevice

Sham rTMSdevice

Task oriented rehabilitationprocedure