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Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)

Key facts

Who runs it
University of California, Los Angeles
Where
Boston, Charleston, and Los Angeles, United StatesSee the 3 sites
Trial code
Status
Recruiting
People taking part
48 people, planned
Started
26 Jul 2021
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Active LIFUP Treatment
  • Sham LIFUP Treatment
Record updated
10 February 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)
  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • Massachusetts General HospitalBoston, United StatesContact: Darin DoughertyTaking people
  • Medical University of South CarolinaCharleston, United StatesContact: Elisabeth CollinsTaking people
  • University of California, Los AngelesLos Angeles, United StatesContact: Margaret G Distler, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Low Intensity Focused UltrasoundTreatment being tested

    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.

    Treatment: Active LIFUP Treatment

  • ShamSham treatment, for comparison

    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.

    Treatment: Sham LIFUP Treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Feasibility of Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
Fit questions
Built from NCT04557891, who can take part
Record updated
10 February 2026