The Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

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.

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type 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.

Interventions

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Focused Ultrasound

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.

Intervention Type DEVICE

Other Intervention Names

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Brainsonix; DWL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No