ow-Intensity Transcranial Focused Ultrasound for the Treatment of Obsessive-Compulsive Disorder

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12624000600549
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-09
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1)Have the capacity to give informed consent to participate in the clinical trial and provide a signed and dated informed consent form.
2)Willing to comply with all study procedures and be available to attend QIMRB and HIRF for the required imaging, clinical assessments and treatment sessions during the study.
3)Aged between 18-50 years.
4)Have a primary diagnosis of Obsessive-Compulsive Disorder (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR; APA, 2022) criteria.
5)Have a diagnosis of OCD for a period greater than 12 months.
In addition, participants must also pass an MRI Safety Screening, a TUS Safety Screening, an Alcohol Screening, and undergo a clinical interview with the chief investigator Dr Mosley to be considered eligible.

Exclusion Criteria

1)Participant’s pharmaceutical treatment changed in the past month.
2)Participant is pregnant or trying to fall pregnant.
3)Participant has ever attempted suicide.
4)Participant has ever been diagnosed with a psychotic disorder.
5)Participant has ever experienced a manic episode.
6)Participant has ever experienced a spontaneous seizure.
7)Participant has a neurological disorder.
8)Participant has ever experienced a traumatic brain injury.
9)Participant has a current substance abuse disorder or alcohol/drug misuse (except tobacco).
10)Participant has any contraindications for MRI scanning.

With regards to criterion 6, seizures elicited via electro-convulsive therapy (ECT) are not considered spontaneous in nature and are not considered part of the exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified