Clinical trial NCT04967560: The Efficacy and Safety of ALIC/NAcc-DBS for Treatment-refractory OCD
Official title: The Efficacy and Safety of Deep Brain Stimulation of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens (ALIC/NAcc-DBS) for Treatment-refractory Obsessive-compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: obsessive-compulsive disorder
deep brain stimulation
anterior limb of internal capsule
nucleus accumbens
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Huashan Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Hunan Brain Hospital
name: First Affiliated Hospital of Kunming Medical University
name: Changhai Hospital
name: SceneRay Corporation, Limited
First posted: 2021-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Treatment response rate
timeFrame: three month after stimulus
Secondary outcomes:
measure: the change scores of Y-BOCS at double-blinded stage
timeFrame: three month after stimulus
measure: the change scores of CGI at double-blinded stage
timeFrame: three month after stimulus
measure: the change scores of HAMD at double-blinded stage
timeFrame: three month after stimulus
measure: the change scores of HAMA at double-blinded stage
timeFrame: three month after stimulus
measure: the change scores of Y-BOCS at open-label stage
timeFrame: six month after stimulus
measure: the change scores of CGI at open-label stage
timeFrame: six month after stimulus
measure: the change scores of HAMD at open-label stage
timeFrame: six month after stimulus
measure: the change scores of HAMA at open-label stage
timeFrame: six month after stimulus
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Brains Hospital of Hunan Province
state: Hunan
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
References: