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Focused Ultrasound for Anxiety Disorders

N/A

Recruiting

Led By Christopher Sege, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia), posttraumatic stress disorder, obsessive-compulsive disorder, or current adjustment disorder with anxiety

Age between 18-65 years old

Must not have

Presence of neurological disorder that contraindicates brain stimulation or neurophysiological recording: Seizure disorder

Lifetime history of traumatic brain injury with loss of consciousness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during session (approx. 45 minutes)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new technology called transcranial focused ultrasound (tFUS) to see if it can help people with anxiety or related concerns manage their emotions better. Participants will come in for

Who is the study for?

This trial is for individuals who have recently started treatment for anxiety or related issues. They should be able to attend three sessions at the Medical University of South Carolina and participate in tasks involving emotional responses, both with and without brain stimulation via tFUS.

What is being tested?

The study tests transcranial focused ultrasound (tFUS), a non-invasive brain stimulation method, to see if it can influence how people with anxiety respond to emotional situations. Participants will receive either active tFUS that temporarily alters brain activity or sham (inactive) tFUS.

What are the potential side effects?

Since this is a non-invasive procedure, side effects are expected to be minimal but may include temporary discomfort or mild headaches from the ultrasound application or sensors worn during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with an anxiety disorder or PTSD.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a seizure disorder that prevents brain stimulation.

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I have had a traumatic brain injury with loss of consciousness in my life.

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I am currently taking naltrexone.

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I have a condition that makes it hard for me to stay still for long periods.

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I have a history of seizures or epilepsy.

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I have conditions or take treatments that increase my risk of seizures.

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I have a neurodegenerative disorder like Alzheimer's, Parkinson's, or Frontotemporal Dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during session (approx. 45 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during session (approx. 45 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during session (approx. 45 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Fear-Potentiated Startle Reflex

Secondary study objectives

Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation

Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment

Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks

+5 more

Other study objectives

Task-Related Regional Brain Activation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Group Receiving Active Stimulation and Sham Stimulation on Separate Days (All Participants)Experimental Treatment2 Interventions

All participants will receive active stimulation and non-active (sham) stimulation on different days. Before the stimulation sessions, all participants will complete experimental tasks during functional magnetic resonance imaging. On the next two study days, all participants will complete tasks before and after receiving active transcranial focused ultrasound (tFUS) on one day and sham (non-active) tFUS on another day. Stimulation (active or sham) is conducted briefly (\< 10 minutes) in between tasks, not during tasks.

0 / 9Eligibility criteria met