NCT04967560

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-11-13
• Completion: 2024-01-29
• First posted: 2021-07-19
• Last updated: 2025-05-18

Locations

7 sites across 1 country: China