Neuromodulation for a Novel OCD Biomarker and Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: OCD
• Intervention / Treatment: Device: high definition transcranial alternating current stimulation

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Reinhart, PhD; Phone Number: 6173539481; Email: rmgr@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Boston University Center for Anxiety and Related Disorders (BU-CARD)
      • Contact: Michael Otto, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

(1) a primary DSM-5 diagnosis of OCD, (2) a score of 16 or greater on the YBOCS (3) at least 18 years of age; and (4) willingness and ability to provide informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

(1) a lifetime history of bipolar or psychotic disorders; (2) history of Tourette syndrome; (3) psychosurgery; (4) substance abuse or dependence (other than nicotine) in the past 3 months; (5) organic brain syndrome, mental retardation or other potentially interfering cognitive dysfunction; (6) severe depression (MADRS score of 30 or greater); (7) suicidal risk as determined by moderate or greater score on the Columbia Suicide Severity Rating Scale (C-SSRS); (8) pregnancy or lactation; (9) changes to pharmacotherapy for OCD or the initiation of cognitive-behavior therapy within the last 3 months; and (10) specific to the tACS and EEG procedures no metal implants in head, any implanted electronic devices, any skin sensitivity, color blindness or impaired vision despite correction, claustrophobia, and any history of epilepsy or neurological disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active HD-tACS; HD-tACS of OFC	Device: high definition transcranial alternating current stimulation; low intensity alternating current to OFC
Sham Comparator: Sham HD-tACS; HD-tACS of OFC	Device: high definition transcranial alternating current stimulation; low intensity alternating current to OFC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
YBOCS	There are 10 YBOCS questions scored 0 to 4. The total Y-BOCS score is the sum of items 1-10. A higher score is worse.	day 5 of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG beta-gamma rhythms		day 5 of intervention
EEG beta-gamma rhythms		1 month after intervention
EEG beta-gamma rhythms		2 months after intervention
EEG beta-gamma rhythms		3 months after intervention
YBOCS	There are 10 YBOCS questions scored 0 to 4. The total Y-BOCS score is the sum of items 1-10. A higher score is worse.	1 month after intervention
YBOCS	There are 10 YBOCS questions scored 0 to 4. The total Y-BOCS score is the sum of items 1-10. A higher score is worse.	2 months after intervention
YBOCS	There are 10 YBOCS questions scored 0 to 4. The total Y-BOCS score is the sum of items 1-10. A higher score is worse.	3 months after intervention

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 4555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes