Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04197921|
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : April 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Device: Exablate Model 4000 Type 2.0/2.1||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD)|
|Actual Study Start Date :||November 27, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Sham/Active ExAblate Treatment Stage 1 and 2
Subject will undergo both Treatment 1 (sham) and Treatment 2 (with enhanced intensity). Subjects are blinded to the order of the sham vs active treatment.
Device: Exablate Model 4000 Type 2.0/2.1
There are two treatment stages. In both stages, the subject will receive both the sham and active ExAblate treatment, and be evaluated for 90 days post-treatment for adverse events. During Stage 1 the subject will receive the moderate intensity Exablate LIFU procedure. During Stage2, the subject will receive the enhanced intensity ExAblate LIFU procedure. The subjects are blinded as to the order of the sham vs active treatment.
- Occurrence of Treatment Emergent Adverse Events [ Time Frame: Post-ExAblate Procedure through 4 Month Follow-Up ]Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197921
|Contact: Julia Zhufirstname.lastname@example.org|
|Contact: Kathy McDermottemail@example.com|
|United States, Virginia|
|West Virginia University: Rockefeller Neuroscience Institute||Recruiting|
|Morgantown, Virginia, United States, 26506|
|Contact: Barbara Harring 304-293-9638 firstname.lastname@example.org|
|Principal Investigator: Ali Rezai, MD|
|Sub-Investigator: Marc Haut, PhD|
|Sub-Investigator: James Mahoney, PhD|