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

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

Interventions

DEVICE

TMS

Paired associative stimulation and single pulse TMS

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  lead NIH

Principal Investigators

• Carlos A Zarate, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-03

Primary Completion

2025-08-07

Completion

2025-08-07

FDA Device

Yes

Countries

• United States

Study Locations