Anxiety Disorders
Conditions
Brief summary
The purpose of the study is to test the effects of brief, low-intensity transcranial focused ultrasound (TUS) on electrophysiological, behavioral, and cognitive markers related to anxiety disorders.
Detailed description
We will test the effects of TUS on self-reported and clinical anxiety states in healthy participants and in those with diagnosed anxiety disorders. Participants in these studies will receive pulsed TUS to the brain regions of interest. We will test whether multiple doses of TUS lead to larger reductions in mental states related to anxiety in comparison to a single dose of TUS.
Interventions
DEVICEGen0b
The ultrasound will be administered to the brain region of interest.
Sponsors
Sanmai Technologies PBC dba Sanmai
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Each experiment arm will have its own group(s).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years of age, as verified via photo identification with date of birth. * Should be an English speaker, as indicated by being able to read and comprehend the consent form. * Experiment 2 : Participants will be included for a past diagnosis of anxiety within the past year.
Exclusion criteria
* Smokes or uses tobacco products or any form of nicotine excessively * History of head injury with loss of consciousness for more than 5 min * Uncorrected hearing or vision impairment, including color blindness * Currently have or history of brain or mental illness judged likely to interfere with testing, including drug and/or alcohol dependence * History of epilepsy * Brain tumors * Takes medications or drugs judged likely to change brain activity, including psychoactive drugs, stimulants, benzodiazepines, and/or others * Factors that may lead to poor EEG or fNIRS recordings (e.g., hairstyle) * Inadequate sleep * Drug, alcohol or prescription drug intoxication, dependence or addiction * Pregnancy, or becoming pregnant during the course of the study * Mild cognitive impairment or impaired decision making * History of migraines * Experience with neurostimulation (which might unbind or alter the results) * Metal implants in their head or face
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Rating Inventory | 1 month | Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety |
Countries
United States
Contacts
Primary ContactLisannette A Ruiz
Backup ContactStephanie French
Outcome results
None listed