Phase 2 N=24 Randomized Double-blind Treatment

Functional Connectivity as a Biomarker of rTMS

Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT03050801 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Functional Connectivity (FC) Changes Between the Left Hippocampus and Left Parietal Cortex — -0.03; 0.13; 0.02; -0.01 Change in z-transformed R-value

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rTMS (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Functional Connectivity (FC) Changes Between the Left Hippocampus and Left Parietal Cortex	-0.03; 0.13; 0.02; -0.01; -0.05; 0.03	—
PRIMARY Associative Memory Test Score Changes	0.08; 0.01; 0.03; 0.08; 0.02; 0.13	—
SECONDARY Implicit Weather Prediction Task (WPT)	-0.03; 0.06; 0.06; -0.02; 0.02; 0.01	—

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.

Eligibility Criteria

INCLUSION CRITERIA

Experiments 1 and 2:

Healthy individuals

Age 18-50 (inclusive)

English speaking and writing

Experiment 3:

Age 18-50 (inclusive)

English speaking and writing

History of mild to moderate TBI

Performance 1 standard deviation below age-adjusted population norms on the

CVLT-2 within the past year from the date of visit.

EXCLUSION CRITERIA

Any current major neurological or psychiatric disorder such as (but not limited to) stroke, Parkinson disease, Alzheimer disease, schizophrenia or major depression

History of seizure

Medications acting on the central nervous system

Ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body

Implanted cardiac pacemaker or auto-defibrillator or pump

Non-removable body piercing

Claustrophobia

Inability to lie supine for 1 hour

Pregnancy, nursing, or plans to become pregnant during the study.

Members of the NINDS Behavioral Neurology Unit (BNU)

For Experiment 2: Participation in Experiment 1

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03050801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.