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NCT Number: NCT05994053

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.

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Key information

Conditions

OCD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Michael Otto, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

high definition transcranial alternating current stimulation

Device

low intensity alternating current to OFC

Primary outcomes

  1. YBOCS

    Time frame: day 5 of intervention

    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.

Secondary outcomes

  1. YBOCS

    Time frame: 1 month after intervention

    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. YBOCS

    Time frame: 2 months after intervention

    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. YBOCS

    Time frame: 3 months after intervention

    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.

  4. EEG beta-gamma rhythms

    Time frame: day 5 of intervention

  5. EEG beta-gamma rhythms

    Time frame: 1 month after intervention

  6. EEG beta-gamma rhythms

    Time frame: 2 months after intervention

  7. EEG beta-gamma rhythms

    Time frame: 3 months after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Reinhart, PhD

CONTACT

[email protected]

6173539481

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 16, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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