Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to understand how cortical stimulation affects Obsessive-Compulsive Disorder

• MagPro X100 by MagVenture (Device): Participants received 5 consecutive days of accelerated cTBSmod to the right frontal pole. Each cTBSmod session was comprised of 1800 pulses, delivered in a continuous train of 600 bursts. Each burst contained 3 pulses at 30 Hz, repeated at 6 Hz. Ten sessions were applied per day (18,000 pulses/day, hourly) (90,000 total pulses) using a Magventure Magpro X100. Stimulation was delivered at 90% resting motor threshold (depth corrected). Localite Neuronavigation System was used to position the TMS coil over the individualized stimulation target.

Primary outcomes

• Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. [Baseline and up to two weeks]: Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Age 18-80
* Primary diagnosis of OCD
* Sufficient severity of OCD symptoms
* Capacity to provide informed consent

Exclusion Criteria:

* Psychiatric or medical conditions or medications that make participation unsafe
* Pregnant or nursing females
* Previous exposure to TMS or ECT
* History of any implanted device or psychosurgery
* Presence of metallic device or dental braces

Participant flow

Outcome results

• Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. (Primary), Count of participants, Participants: rTMS 4

Adverse events

Time frame: Baseline and through study completion (e.g., up to approximately 4 weeks)

Other adverse events by term

Limitations and caveats: This pilot study provides preliminary evidence of the safety, feasibility, and efficacy of a 5-day individualized, accelerated, high-dose, cTBSmod protocol for treatment-refractory OCD. Controlled trials are needed to test these promising findings.

• Results publication: Williams NR, Sudheimer KD, Cole EJ, Varias AD, Goldstein-Piekarski AN, Stetz P, Lombardi A, Filippou-Frye M, van Roessel P, Anderson K, McCarthy EA, Wright B, Sandhu T, Menon S, Jo B, Koran L, Williams LM, Rodriguez CI. Accelerated neuromodulation therapy for Obsessive-Compulsive Disorder. Brain Stimul. 2021 Mar-Apr;14(2):435-437. doi: 10.1016/j.brs.2021.02.013. Epub 2021 Feb 23. No abstract available. PMID 33631349

• Study Protocol and Statistical Analysis Plan (PDF, 2021-04-22)

• Carolyn Rodriguez, MD, PhD, Principal investigator, Stanford University
• Nolan Williams, MD, Study director, Stanford University