COMPLETED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Influence on Plasticity of Brain Temperature

Quick Facts

Study Start:2016-05-03

Study Completion:2025-08-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT02363296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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.	* 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. * 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. * Have an alcohol or substance abuse problem. * NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.

* 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.
* 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.
* Have an alcohol or substance abuse problem.
* NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.

Contacts and Locations

Principal Investigator

Carlos A Zarate, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05-03

Study Completion Date2025-08-07

Study Record Updates

Study Start Date2016-05-03

Study Completion Date2025-08-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Healthy Volunteers