Investigating how brain temperature affects brain stimulation responses

Influence on Plasticity of Brain Temperature

This study is testing how brain temperature affects the way healthy people respond to a treatment called transcranial magnetic stimulation (TMS) to see if it can be made more effective.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 35 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT02363296 on ClinicalTrials.gov

What this trial studies

This study aims to explore the effects of brain temperature on the response to transcranial magnetic stimulation (TMS) in healthy volunteers. It utilizes EEG to optimize TMS delivery by triggering stimulation based on brain wave phases. Participants will undergo screening, MRI scans, and multiple outpatient visits to assess their responses to TMS under varying conditions. The goal is to enhance the effectiveness of TMS by understanding how brain activity influences its outcomes.

Who should consider this trial

Good fit: Ideal candidates are healthy, right-handed adults aged 18 to 35.

Not a fit: Patients with neurological disorders or those taking certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved TMS techniques that enhance treatment for neurological disorders.

How similar studies have performed: While the approach of using EEG to optimize TMS is innovative, similar studies have shown promise in enhancing brain stimulation techniques.

Eligibility criteria

* INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.
* 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.

Where this trial is running

Bethesda, Maryland

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

Study contacts

• Principal investigator: Carlos A Zarate, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Conor D Reid

Conditions Healthy Volunteers; Paired Associative Stimulation; Brain Cooling; Brain Cooling Helmet; Repetitive TMS; EEG phase-triggered TMS