Imaging-Guided Low Intensity Focused Ultrasound (LIFU) (LIFU)
Obsessive-Compulsive Disorder
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, LIFU, Low Intensity Focused Ultrasound
Eligibility Criteria
Inclusion Criteria:
- 1. Outpatients, males and females, 21-55 years of age.
- 2. Principal diagnosis of OCD according to the DSM-5 with duration of ≥2 years.
- 3. Subjects with at least moderate OCD, defined by Yale-Brown Obsessive Compulsive Scale (YBOCS) (27) score of >19.
- 4. Had at least ten sessions of ERP in expert hands.
5. Had trials of at least two SSRIs or one SSRI and clomipramine.
- Treatment failure/non-response: As per the MGH-TRQ-OCD, minimal or no meaningful clinical benefit despite an adequate dose and duration of treatment;
- Adequate duration: At least 8 weeks of treatment with SSRI or clomipramine
- Adequate dose: Defined by the USPI labeling
- 6. If on medication, must be maintained on SRI medications at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
- 7. If subjects are currently undergoing Exposure and Response Prevention (ERP) treatment, they must be in the maintenance stage with stable ERP "dosing" for at least 2 months.
- 8. Willing and able to adhere to the study schedule, which requires 6 sonication/scan visits over two weeks and follow up visits for up to 6 months.
Exclusion Criteria:
- 1.Subjects will be excluded with a history of more than three (3) previous failed treatment trials of SSRIs or clomipramine (not including any current medication trial) given for an adequate duration at an adequate dose.
- 2. Experimental therapy, either medication or device, within past 30 days.
- 3. TMS in last 30 days.
- 4. Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale (28) or a history of attempted suicide in the past year.
- 5. History of epilepsy or seizure (except febrile) or increased risk of seizure. (N.B. We are not aware of evidence that LIFU can induce seizures; however, we decided to incorporate similar safeguards to those used in TMS studies.
- 6. Contraindications for MRI, including any metal in the head, metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- 7. Subjects with significant neurological disorder or insult, ablative surgery or DBS.
- 8. History of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine).
- 9. Unstable medical or neurological condition
- 10. Women of childbearing potential and not using a medically accepted form of contraception such as: the consistent use of an approved hormonal contraception (birth control pill/patches, rings); an intrauterine device (IUD); Contraceptive injection (Depo-Provera); double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam); Sexual abstinence (no sexual intercourse) or sterilization.
- 11. Taking regular dose of benzodiazepines in excess of equivalent to clonazepam 4 mg per day.
- 12. Mini-Mental State Exam (MMSE) less than 24
- 13. Current or prior history, per DSM-5 criteria, of bipolar I disorder, schizophrenia or other psychotic disorders, autism or autistic spectrum disorders, borderline PD, antisocial PD, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, a current diagnosis of Tourette's disorder. Co-morbid depression is allowed as long as OCD is considered primary.
Sites / Locations
- Massachussetts General HospitalRecruiting
- Baylor College of Medicine
- MD Anderson
Arms of the Study
Arm 1
Experimental
LIFU in OCD group
Each subject will receive 3 LIFU sessions epr week for two weeks (6 total image-guided treatments). A total of 20 sonications will be administered to one side of the head, with a derated (based on FDA standard of 0.3 dB/cm-MHz) spatial-peak temporal-average intensity (i.e., Ispta) of approximately 720mW/cm2, each lasting 30 s, separated by 30 s pause intervals. Thus, total duration of sonication will be 10 minutes, the same as used in our study of VS LIFU in healthy subjects. Sonication will be administered within a 3T Siemens Prisma scanner. During sonication, we will use the 20-channel head coil as the 32-or 64-channel coil does not allow enough space to fit the transducer. In summary, the entire sequence of 20 sonications, each lasting 30s, separated by 30s pause intervals, will be administered over 20 minutes for a total duration of sonication equal to 10 minutes.