Exploring Non-Invasive Brain Stimulation Techniques
Development of Non-Invasive Brain Stimulation Techniques
NA · National Institutes of Health Clinical Center (CC) · NCT03351764
This study is testing different brain stimulation techniques to see how they can better help people with mental health and neurological issues.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03351764 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the effectiveness of noninvasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), for diagnosing and treating psychiatric and neurological conditions. Participants, aged 18-65, will undergo a screening process followed by MRI sessions and multiple substudies involving various stimulation parameters. The research focuses on understanding how different stimulation settings affect brain function and responses. By systematically exploring these parameters, the study seeks to optimize NIBS applications.
Who should consider this trial
Good fit: Ideal candidates are healthy native English speakers aged 18 to 65 who can provide informed consent.
Not a fit: Patients with a history of significant psychiatric disorders, seizures, or structural brain lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved diagnostic and therapeutic strategies for psychiatric and neurological disorders.
How similar studies have performed: While there have been studies on NIBS, this research aims to systematically explore a largely uncharted parameter space, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 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. EXCLUSION CRITERIA (for all substudies): * 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.
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: Eva J Wiener
- Email: eva.wiener@nih.gov
- Phone: (312) 222-3551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Normal Physiology, Non-Invasive Brain Stimulation, fMRI, TMS-Evoked Potential, Transcranial Magnetic Stimulation, EEG