The Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder

NCT04775875 | Unknown FDA Device

• 1 other identifier: fUS-OCD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to determine the safety and efficacy of ultrasound as a treatment for Obsessive Compulsive disorder.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (4)

• Yale-Brown Obsessive Compulsive Disorder Scale (Y-BOC)

  This instrument is designed to evaluate the severity of symptoms for Obsessive Compulsive Disorder. The Y-BOC is composed of 10 items, and uses a scale that ranges from 0-4 based on the individuals mark going from 0 as no symptoms to 4 extreme symptoms for a total possible score of 40. Severity range is as follows: subclinical OCD is indicated by scores ranging from 0-7, mild OCD is indicated by scores ranging from 8-15, moderate OCD is indicated by scores ranging from 16-23, severe OCD is indicated by scores ranging from 24-31, and extreme OCS is indicated by scores ranging from 32-40. Moderate to extreme symptoms are clinically significant. For treatment of OCD, a clinically significant change must decrease greater than or equal to 35% relative to baseline. This amount of change is also most predictive of treatment response.

  Baseline

• Beck Anxiety Inventory (BAI)

  The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.

  Baseline

• Beck Depression Inventory (BDI-II)

  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

• Global Rating of Change (GRC)

  The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.

  Baseline

Secondary Outcomes (4)

• Yale-Brown Obsessive Compulsive Disorder Scale (Y-BOC)

  8 weeks from baseline

• Beck Anxiety Inventory (BAI)

  8 weeks from baseline

• Beck Depression Inventory (BDI-II)

  8 weeks from baseline

• Global Rating of Change (GRC)

  8 weeks from baseline

Study Arms (1)

Active

EXPERIMENTAL

Patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the caudate. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space.

Device: Focused Ultrasound

Interventions

Focused Ultrasound DEVICE

The DWL Doppler ultrasound device enables visual and auditory wave form confirmation of cerebral arteries, and optical tracking technology (eg, AntNeuro Visor2 system) may be used in tandem with the Brainsonix Pulsar 1002 ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement.

Also known as: Brainsonix; DWL

Active

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Obsessive Compulsive Disorder
• Score greater than 15 on the Yale-Brown Obsessive Compulsive Scale (Y- BOCS)
• Failure to remit with 3 SSRIs, antidepressants and/or anxiolytics
• Must be willing to comply with the study protocol
• English Proficiency
• At least 18 years of age

You may not qualify if:

• Subjects not English proficient
• Subjects unable to give informed con-sent
• 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
• 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 (2)

Neurological Associates of West LA

Santa Monica, California, 90403, United States

Location

Neurological Associates of West Los Angeles

Santa Monica, California, 90403, United States

Location

Related Publications (3)

• Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4.

  PMID: 16585942 BACKGROUND

• Rapoport JL. Obsessive compulsive disorder and basal ganglia dysfunction. Psychol Med. 1990 Aug;20(3):465-9. doi: 10.1017/s0033291700016962. No abstract available.

  PMID: 2236357 BACKGROUND

• Welter ML, Burbaud P, Fernandez-Vidal S, Bardinet E, Coste J, Piallat B, Borg M, Besnard S, Sauleau P, Devaux B, Pidoux B, Chaynes P, Tezenas du Montcel S, Bastian A, Langbour N, Teillant A, Haynes W, Yelnik J, Karachi C, Mallet L; French Stimulation dans Trouble Obsessionnel Compulsif (STOC) Study Group. Basal ganglia dysfunction in OCD: subthalamic neuronal activity correlates with symptoms severity and predicts high-frequency stimulation efficacy. Transl Psychiatry. 2011 May 3;1(5):e5. doi: 10.1038/tp.2011.5.

  PMID: 22832400 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Sheldon Jordan, MD

  Neurological Associates of West LA

  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: February 25, 2021
• First Posted: March 1, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)