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

NCT02363296 | Completed FDA Device

• 2 other identifiers: 15006615-M-0066
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Paired Associative Stimulation; Brain Cooling (Main Study); Brain Cooling Helmet (Main Study); Repetitive TMS (rTMS); EEG phase-triggered TMS

Outcome Measures

Primary Outcomes (1)

• Motor evoked potential amplitude

  amplitude of motor evoked potentials recorded immediately after paired associative stimulation TMS.

  immediate

Study Arms (1)

EEG phase-triggered PAS

EXPERIMENTAL

TMS triggered to a specific phase of the EEG mu rhythm

Device: TMS

Interventions

TMS DEVICE

Paired associative stimulation and single pulse TMS

EEG phase-triggered PAS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Main Study:
• To be eligible for this research study participants must:
• Be between 18 and 50 years of age.
• Be right-handed.
• Able to abstain from food or drinks containing caffeine 24 hours before the last 3 session visits. The screening visit does not require the ability to abstain from food or drinks containing caffeine.
• Able to abstain from tobacco on the day of the last three session visits. The screening visit doesn t require the ability to abstain from tobacco.
• Sub-study: Phase-triggered paired associative stimulation (PAS)
• Males and females between 18 and 35 years of age.
• Subjects must be able to give written informed consent prior to participation in this study.

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).
• NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Carlos A Zarate, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 16, 2015
• Study Start: May 3, 2016
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09-30

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)