Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT04967560
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.
Study:
NCT04967560
Study Brief:
Protocol Section:
NCT04967560