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Influence on Plasticity of Brain Temperature

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02363296
Recruitment Status : Recruiting
First Posted : February 16, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthly Volunteers Device: TMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: EEG phase-triggered PAS
TMS triggered to a specific phase of the EEG mu rhythm
Device: TMS
Paired associative stimulation and single pulse TMS




Primary Outcome Measures :
  1. Motor evoked potential amplitude [ Time Frame: immediate ]
    amplitude of motor evoked potentials recorded immediately after paired associative stimulation TMS.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.<TAB>
  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Shannon Exley (301) 827-0176 shannon.exley@nih.gov
Contact: Sarah H Lisanby, M.D. (301) 451-3029 lisanbysh@mail.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sarah H Lisanby, M.D. National Institute of Mental Health (NIMH)

Additional Information:
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT02363296    
Other Study ID Numbers: 150066
15-M-0066
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 3, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Paired Associative Stimulation (PAS)
Brain Cooling - Selected
Brain Cooling Helmet
Repetitive TMS (rTMS)
EEG phasxe-triggered TMS