CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
rTMSdevice
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/NCT03050801
NCT03050801Phase 2Completed

Functional Connectivity as a Biomarker of rTMS

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Feb 13, 2017·Updated Apr 12, 2021

In Brief

A Phase 2 clinical trial evaluating rTMS for Traumatic Brain Injury. Completed, enrolled 68 participants across 1 site.

Detailed Summary

Background: Traumatic brain injury (TBI) damages the connections between brain cells. This can lead to problems like memory loss. Repetitive transcranial magnetic stimulation (rTMS) can help improve connections between brain areas in healthy people. Researchers want to see if it can be useful in patients with memory problems after TBI. Objective: To see how repetitive transcranial magnetic stimulation can be used to improve the connections between parts of the brain and whether this will lead to changes in memory. Eligibility: Adults 18-50 years old with TBI who can speak and write in English. Healthy volunteers the same age and English ability. Design: Participants will be screened with a neurological exam and may have a urine pregnancy test. Participants with TBI will have 7-15 visits. Healthy volunteers will have 2-8 visits. At the visits, participants will have all or some of the following: * MRI for about 1 hour. Participants will lie in a machine that takes pictures in a magnetic field. Participants will do some memory tasks. * Memory and attention tasks with pictures and with a computer * Questions about their mental state and well-being * TMS: A wire coil is held on the scalp and a short electrical current passes through it. Participants will hear a click and feel a pulling or twitch. They may be asked to make simple movements. rTMS is repeated magnetic pulses in short bursts. They will have this for about 20 minutes. A week after the last visit, some participants will return for a memory test.

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 13, 2017
Enrollment StartMar 24, 2017
Primary CompletionMar 10, 2020
Study CompletionAug 7, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.4 years ago

Interventions

rTMSdevice

Altering the connectivity of trans-synaptic pathways