Main Study: Influence on Plasticity of Brain Temperature Sub-Study: Phase Triggered Paired Associative Stimulation (PAS)

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

Sub-Study: Phase Triggered Paired Associative Stimulation (PAS) (completed - analysis only) Background: -Previous research has shown that the brain s activity changes with changes in brain waves. We can study brain activity with a procedure called transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation. EEG allows for measuring ongoing brain waves. The goal of this study is to optimize TMS delivery by utilizing EEG-triggered TMS. Objectives: -To see if changes in brain waves change the brain and body s response to TMS. Eligibility: -Healthy, right-handed adults age 18-35. Design: * Participants will be screened under another protocol with medical history and physical exam. They may take a pregnancy test. They will have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. with: * Participants will have up to 4 outpatient visits lasting 2-3 hours each (4 outpatient visits). The following procedures may occur at a visit: * Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. * Electroencephalography (EEG): Small electrodes on the scalp record brain waves. * Electromyography (EMG): Small sticky electrodes on the skin measure muscle activity. * Transcranial magnetic stimulation (TMS): A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity. Main Study: Influence on Plasticity of Brain Temperature (completed - analysis only) Background: \- Brain activity changes with changes in body temperature. Brain activity can be studied with a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool the brain through the scalp using a cooling cap. They want to see if cooling changes the brain and body s response to TMS. Objectives: \- To look at the effects of cooling on the brain. Eligibility: \- Right-handed adults age 18-50 who can abstain from caffeine and tobacco. Design: * Participants will be screened with medical history and physical exam. They will be asked about alcohol use, smoking, and substance abuse. They may take a pregnancy test. They may have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. * Participants will have 3 outpatient visits. The following procedures will occur at each visit. * Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through the cap. It will feel like an ice pack in a towel. Their core temperature will be monitored. Their temperature will also be measured under their tongue and on scalp, stomach, forearm, and calf. * Participants will have TMS before and after wearing the cap. A brief electrical current will pass through a wire coil held on their scalp. Electrodes that detect muscle movement will be placed on their hand. They will also have repetitive TMS, which uses repeated magnetic pulses. Their wrist will also receive a shock.

Key facts

Study ID

NCT02363296

Run by

National Institute of Mental Health (NIMH)

People needed

44

Starts

2016-05-03

Expected to finish

2025-08-07

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Main Study:
• Participants will be excluded from this research study if they:
• Are taking medications of the following classes: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and antihistamines.
• Have a heart rate that exceeds 100 bpm (resting tachycardia).
• Have a history of psychiatric condition(s).
• Have a neurologic disorder such as a history of brain tumor, stroke, central nervous system infection, epilepsy, cerebrovascular disease, dementia, head trauma, or increased intracranial pressure.
• Have surgically or traumatically implanted metallic foreign bodies such as, pacemakers, medication pumps, implanted hearing aids, defibrillators, metal plates in the skull or metal implants in the skull or eyes (other than dental fillings), intracardiac lines, or any other condition/device that might be physically hazardous during TMS or magnetic resonance imaging (MRI), or might distort the images.
• Are unable to lie flat on back for up to 1 hour.
• Have claustrophobia or a feeling of discomfort from being in small, enclosed spaces of enough severity to prevent MRI scanning.
• Are pregnant or have a positive pregnancy test before the research procedure due to the risks associated with MRI scans and TMS.
• Have abnormal findings in clinical MRI that we will do during the screening visit.
• Have any abnormal or focal finding on the neurological exam.
• Have a known hearing loss.
• Have an alcohol or substance abuse problem, as determined by the Alcohol, Smoking and Substance Abuse Screening Test (ASSIST).
• Have sensitivity to coldness. (main experiment only, not an exclusion for the sub-study which does not utilize cooling)
• NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.
• Sub-study: Phase-triggered paired associative stimulation (PAS)
• Individuals taking medication that, in the opinion of the investigator, significantly lowers seizure threshold.
• Have a history of psychiatric condition(s).
• Have a neurologic disorder such as a history of brain tumor, stroke, central nervous system infection, epilepsy, cerebrovascular disease, dementia, head trauma, or increased intracranial pressure.
• Have abnormal findings in MRI that will be conducted during screening or prior to TMS under the current protocol
• Are pregnant or have a positive pregnancy test before the beginning of the study due to the risks associated with TMS.
• Subjects who have hearing loss that has been clinically evaluated and diagnosed.
• Any implant, prosthesis or other permanent alteration of the body that, in the opinion of the investigator, would be unsafe with TMS or that would produce an artifact that would compromise the integrity of data.
• Positive test for HIV.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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