Influence on Plasticity of Brain Temperature
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|ClinicalTrials.gov Identifier: NCT02363296|
Recruitment Status : Recruiting
First Posted : February 16, 2015
Last Update Posted : February 5, 2020
- 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.
- To look at the effects of cooling on the brain.
- Right-handed adults age 18-50 who can abstain from caffeine and tobacco.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Healthly Volunteers||Device: TMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence on Plasticity of Brain Temperature|
|Actual Study Start Date :||May 3, 2016|
|Estimated Primary Completion Date :||September 18, 2023|
|Estimated Study Completion Date :||October 17, 2023|
Experimental: EEG phase-triggered PAS
TMS triggered to a specific phase of the EEG mu rhythm
Paired associative stimulation and single pulse TMS
- Motor evoked potential amplitude [ Time Frame: immediate ]amplitude of motor evoked potentials recorded immediately after paired associative stimulation TMS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363296
|Contact: Shannon Exley||(301) firstname.lastname@example.org|
|Contact: Sarah H Lisanby, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Sarah H Lisanby, M.D.||National Institute of Mental Health (NIMH)|