Anxiety
Conditions
Brief summary
This study is examining the effects of noninvasive brain stimulation on anxiety. Low-intensity focused ultrasound (LIFU) will be utilized to neuromodulate the brain prior to a task (NPU). Physiological recordings will be taken throughout (EEG, EMG, HR, BP, RR, GSR).
Detailed description
This study is a research project examining the effects of noninvasive brain stimulation on anxiety. This study will help us to better understand possible treatments for patients diagnosed with anxiety disorders. Participants will undergo a functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, to image the bone and brain tissue. Participants will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Participants will undergo a threat task involving brief (100ms) shocks (1-5mA) and startle noises. Brain signals (EEG), muscle twitch (EMG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored throughout. Participants will be asked to complete behavioral questionnaires.
Interventions
A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can reduce reactions to sensory stimuli.
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
Sponsors
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will experience the same setup in real and sham conditions. The gel puck used to couple the ultrasound signal will either have a blocking disk, or no blocking disk to either allow or block the ultrasound signal.
Intervention model description
Participants will act as their own sham - sham vs real will be conducted in separate study visits. 2 arms exist for 2 variations of the NPU task.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* High or low trait anxiety
Exclusion criteria
* claustrophobia * Contraindications to MRI (implants) * Contraindications to CT (pregnancy) * Active medical disorder with CNS effects (e.g. Alzheimers) * History of neurologic disorder (e.g. Parkinson's, epilepsy) * History of head injury w/ LOC for \>10 min * History of alcohol or drug dependence * History of current cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in EMG eye startle reflex | Through study completion, an average of 2 weeks | Attenuated amplitude of startle reflex during uncertain and predictable threat tasks with lifu compared to sham. |
| Change in heart rate using ECG | Through study completion, an average of 2 weeks | Attenuation of hear rate increases due to startle tasks in lifu compared to sham condition |
Countries
United States
Outcome results
None listed