NCT05994053

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2024Aug 2026

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

August 8, 2023

Last Update Submit

September 15, 2025

Conditions

OCD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • YBOCS

    1 month after intervention

  • YBOCS

    2 months after intervention

  • YBOCS

    3 months after intervention

  • EEG beta-gamma rhythms

    day 5 of intervention

  • EEG beta-gamma rhythms

    1 month after intervention

  • +2 more secondary outcomes

Study Arms (2)

Active HD-tACS

ACTIVE COMPARATOR

HD-tACS of OFC

Device: high definition transcranial alternating current stimulation

Sham HD-tACS

SHAM COMPARATOR

HD-tACS of OFC

Device: high definition transcranial alternating current stimulation

Interventions

high definition transcranial alternating current stimulationDEVICE

low intensity alternating current to OFC

Active HD-tACSSham HD-tACS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Center for Anxiety and Related Disorders (BU-CARD)

Boston, Massachusetts, 02215, United States

RECRUITING

Central Study Contacts

Robert Reinhart, PhD

CONTACT

6173539481rmgr@bu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 16, 2023

Study Start

July 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)