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Development of Non-Invasive Brain Stimulation Techniques

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ClinicalTrials.gov Identifier: NCT03351764
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief Summary:

Background:

Noninvasive brain stimulation (NIBS) may help diagnose and treat psychiatric and neurological illness. But there is not enough research on how to apply NIBS. This includes how strong to make it, where on the brain to apply it, and for how long. Researchers also want to see what the brain is doing when it receives NIBS.

Objective:

To increase the effectiveness of NIBS.

Eligibility:

Healthy native English speakers ages 18-65

Design:

Participants will be screened under another protocol with:

Medical and psychiatric history

Psychiatric evaluation

Physical exam

Urine tests

All participants will start with a 2-hour visit for screening. (see below). They may learn how to do tasks that will be used later. After the screening session, they will be scheduled for an MRI session.

The next part of the study is 4 substudies. Each substudy includes up to 4 sessions. A session is usually 2-3 hours but can last up to 8 hours. Participants can join multiple substudies, but only 1 at a time. They can do only 1 session on a given day.

Each substudy includes the following:

Behavioral tests: Interviews; questionnaires; simple tasks; and tests of memory, attention, and thinking

Electromyography: Small sticky electrodes on the skin measure muscle activity.

Transcranial magnetic stimulation: A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity.

Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. A coil is placed over the head. They will perform simple tasks while in the scanner. They may also get TMS.

Electroencephalography: Small electrodes on the scalp record brain waves.

Sponsoring Institution: National Institute of M


Condition or disease
Normal Physiology

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Development of Non-Invasive Brain Stimulation Techniques
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : March 1, 2029
Estimated Study Completion Date : March 1, 2029

Group/Cohort
1
Healthy Volunteers 18-65 years of age



Primary Outcome Measures :
  1. electrophysiological: Motor evoked potentials and TMS-evoked potentials: amplitudes and latencies [ Time Frame: within session ]
    amplitude changes

  2. Pre-post change in behavioral performance (RT and accuracy) [ Time Frame: with session ]
    performance changes

  3. Pre-post change in fMRI BOLD response. [ Time Frame: within session ]
    fMRI changes



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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy adult volunteers@@@
Criteria
  • INCLUSION CRITERIA (for all substudies):

Male and female subjects between 18 and 65 years of age.

Subjects must be able to give written informed consent prior to participation in this study.

All subjects must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers .

For cognitive experiments utilizing language stimuli only native English speakers will be enrolled.

EXCLUSION CRITERIA (for all substudies):

Women who are pregnant or breastfeeding.

History of any Axis I DSM-IV disorder, except alcohol abuse outside of one year.

History of seizure (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, known structural brain lesion.

Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Excluded medications and substances include: imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel s dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline.

A history of drug or alcohol abuse within 1 year or a lifetime history of drug or alcohol dependence (DSM-IV criteria).

Presence of ferromagnetic metal in the body, for example metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).

Subjects with an unstable or serious medical or neurological disorder.

No concurrent medications, such as psychotropic drugs, that affect brain function.

Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.

Positive test for HIV.

Subjects who have hearing loss that has been clinically evaluated and diagnosed.

Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 60 minutes, and would feel uncomfortable in the MRI machine (for subjects doing imaging component of the study only).

A current NIMH employee or staff or their immediate family member.

Participant is concurrently participating in another substudy in this protocol, or in any other study involving NIBS.


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): NCT03351764


Contacts
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Contact: Cristina Abboud (301) 827-1874 cristina.abboud@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center 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: NCT03351764     History of Changes
Other Study ID Numbers: 180015
18-M-0015
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 9, 2019

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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) ):
Non-Invasive Brain Stimulation
fMRI
TMS-Evoked Potential
Transcranial Magnetic Stimulation (TMS)
EEG