Neuromodulation for a Novel OCD Biomarker and Treatment

OCD Clinical Trial

Official title:

Neuromodulation for a Novel OCD Biomarker and Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994053
• Other study ID #: 4555
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: October 2023
• Source: Boston University Charles River Campus
• Contact: Robert Reinhart, PhD
• Phone: 6173539481
• Email: rmgr[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• OCD

Intervention

Device:
• high definition transcranial alternating current stimulation
low intensity alternating current to OFC

Locations

Country	Name	City	State
United States	Boston University Center for Anxiety and Related Disorders (BU-CARD)	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	EEG beta-gamma rhythms		day 5 of intervention
Secondary	EEG beta-gamma rhythms		1 month after intervention
Secondary	EEG beta-gamma rhythms		2 months after intervention
Secondary	EEG beta-gamma rhythms		3 months after intervention