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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Medical University of South Carolina | OTHER |
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There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. Anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.
Anxiety disorders have tremendous disease burden in the United States. Up to 1 in 3 Americans will be diagnosed with an anxiety disorder in their lifetimes. Anxiety treatment is typically consisting of psychotherapy (e.g. cognitive behavioral therapy) and medication management (e.g. benzodiazepines, selective serotonin reuptake inhibitors, etc). With major depressive disorder, rTMS is a suitable alternative treatment for refractory depression, rTMS is not approved for treatment of anxiety, nor can rTMS stimulate deep enough to reach those brain circuits involved in anxiety (e.g. the amygdala). Focused ultrasound is a new treatment modality being developed for several different neuropsychiatric conditions. In this study, the investigators propose to randomize 48 individuals to either active or sham treatment. Each participant will be evaluated to establish a baseline diagnose of generalized anxiety disorder, and then will be reassessed after each treatment session (of which there are four). One week and one month after the last treatment session, the investigators will conduct follow-up evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Intensity Focused Ultrasound | Experimental | Device: Low Intensity Focused Ultrasound Device Low Intensity Focused Ultrasound Pulsation (LIFUP) of amygdala (a key area for anxiety) will be performed during two sessions. The proposed experiment will involve behavioral (e.g. HAM-A) and paramedical (i.e., MRI/fMRI) measurements just before and after each of the two LIFUP sessions (i.e., 5 non-consecutive minutes of stimulation in each session). The device does not produce a sound when operating and as such, the active group will well blinded. |
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| Sham | Sham Comparator | Sham Treatment consists of placing the device but not turning it on. The device does not produce a sound when operating and as such, the sham group will well blinded. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active LIFUP Treatment | Device | 8 LIFUP Treatments |
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| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) | HAM-A is a rating scale for measuring the severity of anxiety symptoms. | 1 week after the fourth LIFUP treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret G Distler, MD,PhD | Contact | (310) 794-1553 | mdistler@mednet.ucla.edu | |
| Andrew Bishay, BS | Contact | 4243719869 | abishay@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Margaret G Distler, MD,PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| Sham LIFUP Treatment | Device | 8 sham LIFUP treatments |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02129 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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