Status:
COMPLETED
Development of Non-Invasive Brain Stimulation Techniques
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Normal Physiology
Eligibility:
All Genders
18-65 years
Phase:
NA
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 m...
Detailed Description
Objectives Noninvasive brain stimulation (NIBS) using magnetic and electrical means, through the use of transcranial magnetic stimulation (TMS) and transcranial direct and alternating current stimula...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03351764
Start Date
January 11 2018
End Date
December 15 2025
Last Update
December 24 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892