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Protocol Details

Functional Connectivity as a Biomarker of rTMS

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-N-0055

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 50

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Explicit Memory;
Implicit Memory;
Memory Disorder

Recruitment Keyword(s)

None

Condition(s)

Traumatic Brain Injury

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: rTMS

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

At the visits, participants will have all or some of the following:

-MRI for about 1 hour. They will lie in a machine that takes pictures in a magnetic field. They 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.

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Eligibility

INCLUSION CRITERIA:

Healthy individuals in Experiments 1 and 2.

Age 18-50 (inclusive)

- English speaking and writing

Patients in 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:

Healthy subjects

- 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

TBI Patients

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

- History of seizure

- Inability to give informed consent

- 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


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Citations:

Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Eric M. Wassermann, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Jack A. Reeves
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D48
10 Center Drive
Bethesda, Maryland 20892
(301) 496-0220
jack.reeves@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03050801

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