Clinical trial NCT04775875: The Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder
Official title: Open Label Study for the Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Disorder Scale (Y-BOC)
timeFrame: Baseline
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: Baseline
measure: Global Rating of Change (GRC)
timeFrame: Baseline
Secondary outcomes:
measure: Yale-Brown Obsessive Compulsive Disorder Scale (Y-BOC)
timeFrame: 8 weeks from baseline
measure: Beck Anxiety Inventory (BAI)
timeFrame: 8 weeks from baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: 8 weeks from baseline
measure: Global Rating of Change (GRC)
timeFrame: 8 weeks from baseline
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West LA
state: California
city: Santa Monica
country: United States
facility: Neurological Associates of West Los Angeles
state: California
Study officials:
affiliation: Neurological Associates of West LA
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rapoport JL. Obsessive compulsive disorder and basal ganglia dysfunction. Psychol Med. 1990 Aug;20(3):465-9. doi: 10.1017/s0033291700016962. No abstract available.
citation: 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.