Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active LIFUP Treatment, Sham LIFUP Treatment.
- Who it may be relevant to
- Registry conditions: Generalized Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
Overview
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.
Detailed description
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.
Interventions
- Device Active LIFUP Treatment
8 LIFUP Treatments - Device Sham LIFUP Treatment
8 sham LIFUP treatments
Primary outcome measures
- Hamilton Anxiety Rating Scale (HAM-A) [Time frame: 1 week after the fourth LIFUP treatment]
Eligibility criteria
Inclusion criteria
- Male or female
- Age 18-65
- Normal or corrected-to normal vision and hearing
- Primary diagnosis of generalized anxiety disorder, moderate/severe per DSM-5. (HAM-A>17) 4a) The duration of the illness must exceed one year.
- Must be medically stable as determined by investigator
- Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
- History of rTMS is permitted, but not required.
Exclusion criteria
- Diagnosis of primary DSM-5 anxiety disorder other than GAD 1a) Affective disorders such as unipolar or bipolar depression are permitted as long as GAD is primary
- Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)
- Contraindication to enter the MRI environment
- Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term)
- Inability to adhere to treatment schedule
- Initiation of new anxiolytic treatment at the time of study randomization
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- University of California, Los Angeles — Los Angeles
- Massachusetts General Hospital — Boston
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT04557891 · CTP-LIFUP-GAD-V1.0