Development of Non-Invasive Brain Stimulation Techniques

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 22, 2017

Keywords

ClinConnect Summary

This clinical trial is studying non-invasive brain stimulation (NIBS) techniques to better understand how they can be used to diagnose and treat mental health and neurological conditions. The goal is to find out the best ways to apply NIBS, including how strong the stimulation should be, where to place it on the brain, and how long it should last. Researchers will also look at how the brain responds to this stimulation during the process.

To participate, individuals must be healthy, between the ages of 18 and 65, and native English speakers. Those interested will go through a screening process that includes a medical history review, a psychiatric evaluation, and some simple tests. If eligible, they can take part in various sessions that might include brain imaging, behavioral tests, and muscle activity measurements. Participants will spend a few hours in each session, and they can join different parts of the study one at a time. It’s important to note that certain medical conditions and a history of specific disorders could exclude someone from participating. This study aims to improve our understanding of brain function and how to safely use NIBS in future treatments.

Gender

ALL

Eligibility 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.