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Neuromodulation for a Novel OCD Biomarker and Treatment

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 31, 2026 → Aug 31, 2027
See other at-risk trials from Boston University Charles River Campus

Record History

  1. Primary and study completion pushed from Aug 31, 2026 to Aug 31, 2027v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2023 to Jul 1, 2024
    • Site details revised
    v3
  4. Start date: Sep 1, 2023 to Dec 1, 2023
    • Study sites: 0 to 1
    • Secondary endpoints: details revised at 3 of 7 entries
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Although multiple treatments for OCD exist, slow symptom decrease, high remission, and significant side effects for some OCD patients limit their efficacy. More research into the precise neural mechanisms and linked cognitive functions in OCD is also necessary. To address both concerns, this study by Dr. Reinhart and his team will test a new, non-invasive, and well-tolerated neuromodulation method for reducing OCD symptoms, based on reward-related rhythms of the orbitofrontal cortex (OFC; a brain region responsible for reward, decision making and other crucial functions that is affected by OCD). This proposal is based on highly encouraging preliminary data in both subsyndromal and treatment-resistant populations that shows rapid reductions in OCD behaviors that last at least 1-3 months. Using high-definition transcranial alternating current stimulation (HD-tACS) guided by EEG brain wave recordings, the study will test whether repetitive modulation of relevant rhythm activity in the OFC can lead to rapid (within five days) and sustainable (up to three months) OCD symptom reduction. This research aims to increase knowledge of OCD and development of effective treatment with minimal side effects.
Trial Details
NCT Number NCT05994053
Lead Sponsor Boston University Charles River Campus
Conditions
(from sponsor)		 OCD
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov