Development of Non-Invasive Brain Stimulation Techniques

NCT03351764 | Completed

• 2 other identifiers: 18001518-M-0015
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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 ...

Conditions

Normal Physiology

Keywords

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

Outcome Measures

Primary Outcomes (4)

• behavioral performance (e.g., reaction time, accuracy)

  performance is compared across conditions

  within session

• TMS evoked potentials

  EEG evoked by TMS is compared across conditions

  within session

• Motor evoked potential amplitude

  EMG evoked by TMS is compared across conditions

  within session

• MRI activation (BOLD response)

  BOLD response is compared across conditions

  within session

Study Arms (2)

arm 1

OTHER

these are within subject repeated measures studies across a number of conditions

Device: TMS

arm 2

PLACEBO COMPARATOR

these are within subject repeated measures studies across a number of conditions (which can include sham TMS as a placebo)

Device: Sham TMS

Interventions

Sham TMS DEVICE

Subjects receive sham TMS via coil designed to produce the clicking sound of active TMS without delivering the magnetic field to the brain.

arm 2

TMS DEVICE

non-invasive transcranial magnetic stimulation is used to temporarily modulation ongoing cortical activity

arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or under protocol 17-M-0181 (Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies).
• For cognitive experiments utilizing language stimuli only native English speakers will be enrolled.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• History of any Axis I DSM-5 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, known structural brain lesion, or with history of any head trauma within 6 months of screening, or, beyond 6 months prior to screening, history of head trauma with evidence of traumatic abnormality appearing on their brain scan, or with loss of consciousness \>5 min, or with other sequelae, excluding headache, lasting \>24 hours.
• 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-5 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Carlos A Zarate, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 24, 2017
• Study Start: January 11, 2018
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 20, 2026

Record last verified: 2025-12-22

Locations

US (1)