The Efficacy and Safety of ALIC/NAcc-DBS for Treatment-refractory OCD

NCT04967560 | Completed DMC

• 1 other identifier: SR1182
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

The present study aims to explore the efficacy and safety of DBS targeted the combination of the anterior limb of internal capsule and nucleus accumbens (ALIC/NAcc-DBS) to refractory OCD, based on multicenter, randomized, double-blinded, sham-stimulation controlled design, that could help to obtain stronger evidence of the efficacy of multiple targets.

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorder; deep brain stimulation; anterior limb of internal capsule; nucleus accumbens

Outcome Measures

Primary Outcomes (1)

• Treatment response rate

  Our primary outcome measure was to compare the treatment response rate (TRR) between the active group and sham-controlled group at the end of three months. (TRR is defined as the number of treatment response/the number of group, a ≥35% reduction in Y-BOCS plus CGI=1or2 met the criteria of treatment response). Note: Y-BOCS, Yale-Brown obsessive-compulsive scale; CGI, clinical global impression.

  three month after stimulus

Secondary Outcomes (8)

• the change scores of Y-BOCS at double-blinded stage

  three month after stimulus

• the change scores of CGI at double-blinded stage

  three month after stimulus

• the change scores of HAMD at double-blinded stage

  three month after stimulus

• the change scores of HAMA at double-blinded stage

  three month after stimulus

• the change scores of Y-BOCS at open-label stage

  six month after stimulus

Study Arms (2)

DBS true-stimulation group

ACTIVE COMPARATOR

The electrical stimulation will be 'turned-on' immediately after programming in true-stimulation group.

Device: deep brain stimulation

DBS sham-stimulation group

SHAM COMPARATOR

The electrical stimulation will be 'turned-off' after programming in sham-stimulation group. The stimulation will begin until after completing three months of Y-BOCS and CGI assessments

Device: deep brain stimulation

Interventions

deep brain stimulation DEVICE

Both group will undergo the DBS surgery. Four weeks after surgery, all patients will visit the clinic with the DBS stimulation in the 'off' state for initial programming of electrical parameters for stimulation. At double-blind visit, the electrical stimulation will be actually 'turned on' immediately after the programming in true-stimulation group, while turn-off in the control group.

DBS sham-stimulation group; DBS true-stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-65 years old;
• a diagnosis of OCD based on The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5);
• suffered from severe OCD symptoms over 5 years with substantial functional impairment;
• the Y-BOCS total score ≥ 25;
• met the criteria of treatment refractory. Treatment refractory is defined as failed 1) at least three adequate therapeutic trials of serotin reuptake inhibitors (SRIs), with clomipramine being one of the SRIs trials, 2) the use of at least two atypical antipsychotics as augmenting agents, 3) at least 20 sessions of therapist-guided cognitive-behavioral therapy while on a therapeutic dose of an SRIs. These patients have "failed" treatment by demonstrating \<25% reduction of Y-BOCS scores or, despite \>25% reduction in YBOCS score, by still experiencing significant impairment from their illness.

You may not qualify if:

• a history of current or past diagnosis of any psychosis according to DSM-5 except for OCD
• any clinical significant neurological disorder, traumatic brain injury, dementia, or medical illness
• any contradiction of neurosurgery
• any current or unstably remitted substance abuse or dependence
• women who are pregnant or preparing for pregnant
• severe suicide risk and tendency according to the investigators' judgements
• participate in any other clinical trials within three months (except for registered studies).

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• West China Hospital: collaborator
• Huashan Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Hunan Brain Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• Changhai Hospital: collaborator
• SceneRay Corporation, Limited: collaborator

Study Sites (7)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Brains Hospital of Hunan Province

Changsha, Hunan, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

Huashan Hospital

Shanghai, Shanghai Municipality, China

Location

West China Hospital

Chengdu, Sichuan, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization of DBS are blinded to evaluators, participants, and programming doctors. The programming doctors used the specific software to allocated the participants, that software was preset random coding program to randomized allocate the subjects. The DBS interface of all patients is displayed as a true stimulus, but the true impulse was running in the background controlled by the software, so that even the programming doctors could not know the grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Mental Health Center

Model Details: All eligible patients who consent to participation and met all inclusion and exclusion criteria will be randomized to active and sham-stimulation group at post-operative.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: July 30, 2021
• Primary Completion: November 13, 2023
• Study Completion: January 29, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)