Open Label Study for the Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obsessive-Compulsive Disorder
- Sponsor
- Neurological Associates of West Los Angeles
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Beck Depression Inventory (BDI-II)
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Beck Depression Inventory (BDI-II)
Time Frame: Baseline
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.
Global Rating of Change (GRC)
Time Frame: Baseline
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.
Beck Anxiety Inventory (BAI)
Time Frame: Baseline
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.
Yale-Brown Obsessive Compulsive Disorder Scale (Y-BOC)
Time Frame: Baseline
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.
Secondary Outcomes
- Beck Depression Inventory (BDI-II)(8 weeks from baseline)
- Yale-Brown Obsessive Compulsive Disorder Scale (Y-BOC)(8 weeks from baseline)
- Beck Anxiety Inventory (BAI)(8 weeks from baseline)
- Global Rating of Change (GRC)(8 weeks from baseline)