CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
rTMS +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/NCT02152540
NCT02152540N/ACompleted

Repetitive Transcranial Magnetic Stimulation to Improve Cognitive Function in TBI

VA Office of Research and Development·interventional·Posted Jun 2, 2014·Updated Jan 15, 2021

In Brief

A clinical study evaluating rTMS and Sham rTMS for Traumatic Brain Injury. Completed, enrolled 33 participants across 1 site.

Detailed Summary

This project will study 40 Veterans identified with symptoms understood to characterize mild to moderate Traumatic Brain Injury (TBI) including Post Traumatic Stress Disorder (PTSD). Following screening and informed consent, Veterans will be randomly assigned to treatment with repetitive Transcranial Magnetic Stimulation (rTMS) or sham rTMS (placebo). Additional examinations will compare brain imaging (structural and functional MRI scans at rest) across participants at baseline, after acute rTMS treatment, and at 6 month followup. The VA population differs significantly from populations that have been included in prior trials of rTMS for many conditions such as depression, chronic pain, and PTSD. Many returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) personnel and Veterans with concussion histories report cognitive problems, such as impaired attention, verbal fluency, poor planning, reduced working memory, and mental flexibility. The investigators hope to show the efficacy and durability of rTMS in treating these symptoms safely in Veterans with co-morbidities.

Study Details

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

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2, 2014
Enrollment StartOct 1, 2014
Primary CompletionSep 30, 2017
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.1 years ago

Interventions

rTMSdevice

Repetitive Transcranial Magnetic Stimulation

Sham rTMSdevice

Placebo Device that simulates active rTMS treatment