Deep brain stimulation: postoperative issues.
Günther Deuschl, Jan Herzog, Galit Kleiner-Fisman...
https://pubmed.ncbi.nlm.nih.gov/16810719Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07031544
Efficacy and Influencing Factors of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder
Led by Shanghai Mental Health Center · Updated on 2025-07-03
60
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai Mental Health Center
Lead Sponsor
H
Huashan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating deep brain stimulation (DBS) targeting the anterior limb of internal capsule and nucleus accumbens (ALIC-NAc) in patients with treatment-refractory obsessive-compulsive disorder (OCD). The study aims to find out whether the timing of DBS activation—at 1, 2, or 3 months after surgery—affects the improvement of OCD symptoms measured by Y-BOCS scores. This multicenter, randomized, open-label trial involves adults who have not responded to standard medications and therapy. Participants will undergo surgery to implant a neurostimulation device in the brain. They will be randomly assigned to one of three groups receiving DBS activation at approximately 30, 60, or 90 days after surgery. Each group includes 20 patients. After activation, participants will be regularly assessed over a six-month follow-up period to compare symptom improvements based on activation timing. During the study, participants will attend scheduled clinical visits for evaluations including OCD symptom scores, depression and anxiety ratings, and quality of life assessments. The main measurement is the difference in OCD symptom improvement three months after DBS activation. Secondary measures include changes in clinical global impression, depression, anxiety, and health survey scores at one, two, and three months post-activation. Safety and suitability assessments will also be conducted throughout the trial, which is expected to complete by March 2027.
CONDITIONS
Brief Title
Efficacy and Influencing Factors of ALIC-NAc Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years old
- Diagnosed with obsessive-compulsive disorder based on DSM-5
- Y-BOCS total score of 25 or higher
- Treatment refractory, defined as inadequate response or intolerance to at least three adequate SSRI trials combined with at least two second-generation antipsychotics
- Inadequate response or intolerance to cognitive behavioral therapy with more than 12 sessions concurrent with adequate SSRI treatment
You will not qualify if you...
- Presence of other psychiatric disorders such as organic mental disorders, paranoid personality disorder, or mental retardation
- Significant risk of suicidal behavior as assessed by investigator
- Severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, neurological, or systemic diseases
- History of organic brain disorders, traumatic brain injury, intractable epilepsy, or other neurological conditions
- Clinically significant abnormalities in physical exams, labs, ECG, or imaging making participation unsuitable
- History of cochlear implant, cardiac pacemaker, defibrillator, or similar device implantation within past six months
- Contraindications to DBS implantation or unfit for surgery
- Confirmed HIV-positive status
- Pregnant or breastfeeding women, or women of childbearing potential with positive pregnancy tests or unable to use effective contraception
- Participation in another drug or device clinical trial currently or within three months prior
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo implantation of an intracranial neurostimulation system through minimally invasive surgery and receive immediate post-operative care.
1 visit (in-person)
Post-operative Follow-up
Duration - 30 to 90 days depending on group assignment
Participants are monitored without stimulation during the post-surgery period until activation of the deep brain stimulation device.
Regular follow-up visits during this period
Treatment
Duration - At least 3 months after DBS activation
Participants receive deep brain stimulation therapy, with activation occurring at 30, 60, or 90 days post-surgery depending on group assignment. The stimulation continues while participants attend scheduled assessments.
Assessments at 1, 2, and 3 months after DBS activation
Trial Site Locations
Total: 10 locations
1
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Actively Recruiting
2
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
3
The Second Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
Actively Recruiting
4
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
5
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Actively Recruiting
6
the Third Hospital of Mianyang
Mianyang, Sichuan, China
Actively Recruiting
7
Shanghai Mental Health Center
Shanghai, China, 200030
Actively Recruiting
8
Huashan Hospital
Shanghai, China
Actively Recruiting
9
Tianjin Huanhu Hospital
Tianjin, China
Actively Recruiting
10
Tianjin Anding Hospital
Tianjing, China
Actively Recruiting
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Research Team
Z
Zhen Wang, Ph.D, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Open-label trial of anterior limb of internal capsule-nucleus accumbens deep brain stimulation for obsessive-compulsive disorder: insights gained.
Daniel Huys, Sina Kohl, Juan Carlos Baldermann...
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Damiaan Denys, Mariska Mantione, Martijn Figee...
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Cristina Belotto-Silva, Juliana Belo Diniz, Dante Marino Malavazzi...
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G M Soomro, D Altman, S Rajagopal...
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Jun Soo Kwon, Joon Hwan Jang, Jung-Seok Choi...
https://pubmed.ncbi.nlm.nih.gov/19210199Cortical Abnormalities Associated With Pediatric and Adult Obsessive-Compulsive Disorder: Findings From the ENIGMA Obsessive-Compulsive Disorder Working Group.
Premika S W Boedhoe, Lianne Schmaal, Yoshinari Abe...
https://pubmed.ncbi.nlm.nih.gov/29377733Emotional Processing in Obsessive-Compulsive Disorder: A Systematic Review and Meta-analysis of 25 Functional Neuroimaging Studies.
Anders Lillevik Thorsen, Pernille Hagland, Joaquim Radua...
https://pubmed.ncbi.nlm.nih.gov/29550459Obsessive-compulsive disorder.
Dan J Stein, Daniel L C Costa, Christine Lochner...
https://pubmed.ncbi.nlm.nih.gov/31371720