The Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder

Neurological Associates of West Los Angeles

Status: Invitation-only

Conditions: Obsessive-Compulsive Disorder

Treatments: Device: Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04775875

fUS-OCD

Details and patient eligibility

About

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

Full description

The present study is being undertaken as an open-label study to evaluate the safety and feasibility of focused ultrasound as an intervention for patients with obsessive compulsive disorder (OCD). Participants in this study will undergo 8 consecutive weekly sessions of transcranial low-intensity focused ultrasound (LIFUP) targeting the caudate of the basal ganglia. The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound for this neurological application. Treatment response will be measured using the Beck Depression & Anxiety Inventories, the Yale-Brown Obsessive-Compulsive Scale, and the Global Rating of Change Scale.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Active

Experimental group

Description:

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.

Treatment:

Device: Focused Ultrasound