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

NCT04250441 | Unknown FDA Device

• 1 other identifier: 32222-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with refractory depression and anxiety.

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Beck Depression Inventory

  \[Primary for patients enrolled for depression\] The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.

  Baseline prior to ultrasound administration (

• Hamilton Anxiety Rating Scale

  \[Primary for patients enrolled for anxiety\] The HAM-A is an observer/rater scale consisting of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  Baseline prior to ultrasound administration

Secondary Outcomes (7)

• Hamilton Anxiety Rating Scale

  After final ultrasound (8 weeks from baseline)

• Beck Anxiety Inventory

  Baseline prior to ultrasound administration

• Beck Anxiety Inventory

  After final ultrasound (8 weeks from baseline)

• Patient Depression Questionnaire

  After final ultrasound (8 weeks from baseline)

• Hamilton Depression Rating Scale

  Baseline prior to ultrasound administration

Study Arms (1)

Treatment

EXPERIMENTAL

All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.

Device: Focused Transcranial Ultrasound

Interventions

Focused Transcranial Ultrasound DEVICE

The FDA has determined that power intensity limits of 720 mW/cm squared at 2 megaHertz is safe for clinical use; the proposed equipment works within these parameters. Furthermore, monitoring sessions up to one hour as proposed in this study are routinely used in patients even with acute brain injury at 2 megaHertz without any reports of complications induced by the ultrasound device. No brain heating, cavitation or bleeding has been identified with the proposed equipment and protocol. For each individual safety can be followed by performing a selective mental status exam at each session completion.

Treatment

Eligibility Criteria

• Age: 18 Years - 93 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (1)

Neurological Associates of West LA

Santa Monica, California, 90403, United States

Location

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MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Sheldon Jordan, M.D.

  Neurological Associates - the Interventional Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: November 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)