Functional Connectivity as a Biomarker of rTMS
Completed · Phase 1/Phase 2
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT03050801
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 68
- Starts
- 2017-03-24
- Expected to finish
- 2020-08-07
- Last updated by the study team
- 2021-04-12
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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