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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2024-01-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy and Mechanism of DBS in VIC and NAcc for Refractory OCD

NCT04228744

Obsessive-Compulsive Disorder Deep Brain Stimulation

UNKNOWN NA

Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder

NCT03463590

Obsessive-Compulsive Disorder

UNKNOWN NA

Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

NCT05160129

Obsessive Compulsive Disorder (OCD)

RECRUITING NA

DBS for Treatment-resistant Obsessive-compulsive Disorder

NCT06360991

Obsessive-Compulsive Disorder (OCD)

NOT_YET_RECRUITING NA

Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder

NCT02590445

Obsessive-Compulsive Disorder

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OCD is a chronic and disabled mental disorder, with one third of patients could hardly get recovery from the medication and psychotherapy. Deep brain stimulation (DBS) is a novel potential surgical treatment for refractory OCD, however, the choose of targets are still controversial. This study aims to investigate the therapeutic efficacy and safety of bilateral DBS of the anterior limb of internal capsule and nucleus accumbens (ALIC/NAcc-DBS) for treatment-refractory OCD. In this multicenter, prospective, and double-blinded study, 64 patients with OCD who met the eligibility criteria will be enrolled and randomized allocated to active and sham-stimulation group, followed up for three months after surgery. Then the blind will be uncover, the sham group switch to true stimulation, all patients will be followed up at six months after surgery. The primary outcome was to compare the treatment response rate between the active group and sham-controlled group at the end of three months after surgery. The secondary outcomes include changes in the Yale-brown obsessive-compulsive scale (Y-BOCS), Hamilton anxiety scale (HAMA), Hamilton depression scale (HAMD), and Clinical global impressions (CGI) scale of both groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obsessive-Compulsive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DBS true-stimulation group

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

Group Type ACTIVE_COMPARATOR

deep brain stimulation

Intervention Type 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

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

Group Type SHAM_COMPARATOR

deep brain stimulation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

deep brain stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No