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Search / Trial NCT04250441

The Use of Transcranial Focused Ultrasound for the Treatment of Depression and Anxiety

Launched by NEUROLOGICAL ASSOCIATES OF WEST LOS ANGELES · Jan 29, 2020

Trial Information

Current as of April 29, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

The present study is designed as an open label study of patients with refractory depression and anxiety to evaluate longer term tolerability and early efficacy of transcranial ultrasound treatment. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. For patients with refractory depression, the target will be the subgenual cingulate (Brodmann's area 25) through a trans temporal scalp window. For patients with anxiety, the target will be the amygdala. Targeting will include reference to scal...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria for Depression:
  • Diagnosis of Major Depressive Disorder
  • Score greater than 13 on the Beck Depression Inventory
  • Failure to remit with 3 antidepressants
  • At least 18 years of age
  • Inclusion Criteria for Anxiety:
  • Diagnosis of Generalized or Acute Anxiety Disorder
  • Score greater than 15 on the Beck Anxiety Inventory
  • Failure to remit with 3 anxiolytics
  • At least 18 years of age
  • Exclusion Criteria for Depression \& Anxiety:
  • Cognitive decline clearly related to an acute illness
  • Subjects unable to give informed consent
  • Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
  • Recent surgery or dental work within 3 months of the scheduled procedure.
  • Pregnancy, women who may become pregnant or are breastfeeding
  • Advanced terminal illness
  • Any active cancer or chemotherapy
  • Any other neoplastic illness or illness characterized by neovascularity
  • Macular degeneration
  • Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
  • Advanced kidney, pulmonary, cardiac or liver failure

About Neurological Associates Of West Los Angeles

Neurological Associates of West Los Angeles is a leading clinical research organization specializing in the advancement of neurological therapies and treatments. With a commitment to enhancing patient care and outcomes, the organization conducts innovative clinical trials that focus on a range of neurological disorders, including epilepsy, multiple sclerosis, and Alzheimer's disease. Equipped with a team of experienced researchers and state-of-the-art facilities, Neurological Associates fosters collaboration with pharmaceutical companies and academic institutions to bring cutting-edge therapies from the lab to the clinic, ensuring a rigorous and ethical approach to clinical research. Their mission is to contribute to the scientific understanding of neurological conditions while prioritizing patient safety and well-being throughout the research process.

Locations

Santa Monica, California, United States

Patients applied

0 patients applied

Trial Officials

Sheldon Jordan, M.D.

Principal Investigator

Neurological Associates - the Interventional Group

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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