CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Repetititve transcranial magnetic stimulationdevice
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/NCT01049802
NCT01049802Phase 2Completed

Evaluation of Therapeutic Effects of Navigation-guided 1 Hz rTMS Administered to the Contralesional Hemisphere in Patients With Stroke

Shirley Ryan AbilityLab·interventional·Posted Jan 14, 2010·Updated Dec 29, 2016

In Brief

A Phase 2 clinical trial evaluating Repetititve transcranial magnetic stimulation for Stroke. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This is a prospective randomized controlled feasibility study to determine whether navigation guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in patients with subacute stroke has a beneficial effect when given concurrently with task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a structural MRI scan for targeting stimulation and therefore structural MRI will be performed on all subjects. In addition the study intends to determine whether measures of motor tract integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor imaging can be used to clarify prognosis of motor recovery and to monitor progress with rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes will be measured immediately post treatment, and at 3 months and 6 months post treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
CollaboratorsNexstim Ltd

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2010
Enrollment StartJan 1, 2010
Primary CompletionNov 1, 2013
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.5 years ago

Interventions

Repetititve transcranial magnetic stimulationdevice

1 Hz rTMS to contralesional hemisphere in patients with stroke