Efficacy and Influencing Factors of ALIC-NAc Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder

NCT07031544 | Recruiting

• 1 other identifier: SMHC-DBS-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and influencing factors of the combination of the anterior limb of internal capsule and nucleus accumbens (ALIC-NAc) deep brain stimulation (DBS) in patients with treatment-refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer is: Does the timing of DBS activation (at 1, 2, or 3 months post-surgery) affect the reduction rate in Y-BOCS scores? Researchers will compare three groups-DBS activated at 1, 2, and 3 months post-surgery-to determine whether earlier or later stimulation leads to greater symptom improvement. Participants will:

• Undergo surgical implantation of an intracranial neurostimulation system targeting ALIC-NAc
• Be randomly assigned to one of three DBS activation timing groups
• Receive regular clinical assessments over a 6-month follow-up period after activation

Conditions

Obsessive - Compulsive Disorder

Keywords

obsessive-compulsive disorder; deep brain stimulation; anterior limb of internal capsule; nucleus accumbens; activation timing

Outcome Measures

Primary Outcomes (1)

• Obsessive-compulsive symptoms improvement

  The severity of OCD symptoms is assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive symptoms improvement is reflected by Y-BOCS reduction rate.

  3-month after DBS activation

Secondary Outcomes (4)

• the change scores of CGI score

  1, 2 and 3-month after DBS activation

• the change scores of HAMD score

  1, 2 and 3-month after DBS activation

• the change scores of HAMA score

  1, 2 and 3-month after DBS activation

• the change of SF-36 score

  1, 2 and 3-month after DBS activation

Study Arms (3)

one-month group

EXPERIMENTAL

DBS activation at 30 ± 7 days post-surgery

Device: deep brain stimulation

two-month group

EXPERIMENTAL

DBS activation at 60 ± 7 days post-surgery

Device: deep brain stimulation

three-month group

EXPERIMENTAL

DBS activation at 90 ± 7 days post-surgery

Device: deep brain stimulation

Interventions

deep brain stimulation DEVICE

Deep Brain Stimulation (DBS) involves the use of stereotactic techniques to implant microelectrodes into specific target nuclei within the brain through minimally invasive surgery. These electrodes are connected via leads to a subcutaneously implanted pulse generator, typically placed beneath the clavicle. By delivering low-intensity electrical pulses, DBS suppresses abnormal intracranial neural activity, thereby alleviating symptoms. Long-term stimulation can also induce neuroplastic changes in neural networks and neurotransmitter systems, contributing to the restoration of neurological function.

one-month group; three-month group; two-month group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-65 years old;
• a diagnosis of OCD based on The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5);
• the Y-BOCS total score ≥ 25;
• met the criteria of treatment refractory. Treatment refractory is defined as failed a) Inadequate response or intolerance to at least three adequate trials of selective serotonin reuptake inhibitors (SSRIs), combined with at least two second-generation antipsychotics as augmentation agents.
• b) Inadequate response or intolerance to cognitive behavioral therapy (CBT) consisting of more than 12 sessions conducted concurrently with adequate dosed SSRIs treatment.

You may not qualify if:

• Presence of other psychiatric disorders such as organic mental disorders, paranoid personality disorder, or mental retardation.
• Individuals deemed by the investigator to be at significant risk of suicidal behavior based on clinical assessment.
• Presence of severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, neurological, or other systemic diseases.
• History of organic brain disorders, traumatic brain injury, intractable epilepsy, or other neurological conditions.
• Clinically significant abnormalities in physical examination, laboratory tests, electrocardiogram, or imaging during screening or baseline that, in the investigator's judgment, make the individual unsuitable for the study.
• History of implantation of a cochlear implant, cardiac pacemaker, cardiac defibrillator, prior unilateral or bilateral implantation of similar devices, or other surgical procedures within the past six months that may affect study participation as judged by the investigator.
• Contraindications to DBS implantation or deemed unfit for surgery by the investigator.
• Confirmed HIV-positive status.
• Pregnant or breastfeeding women, women of childbearing potential with positive blood/urine HCG results at screening, those unable to use effective contraception during the study, or those planning to conceive within three months after study initiation.
• Participation in another drug or medical device clinical trial currently or within three months prior to screening.
• Any other condition deemed by the investigator to render the individual unsuitable for the study.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Huashan Hospital: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Tianjin Anding Hospital: collaborator
• Tianjin Huanhu Hospital: collaborator
• The First Hospital of Hebei Medical University: collaborator
• First Affiliated Hospital of Jinan University: collaborator
• The Second Affiliated Hospital of Xinxiang Medical College: collaborator
• the Third Hospital of Mianyang: collaborator

Study Sites (10)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

The Second Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

RECRUITING

the Third Hospital of Mianyang

Mianyang, Sichuan, China

RECRUITING

Shanghai Mental Health Center

Shanghai, 200030, China

RECRUITING

Huashan Hospital

Shanghai, China

RECRUITING

Tianjin Huanhu Hospital

Tianjin, China

RECRUITING

Tianjin Anding Hospital

Tianjing, China

RECRUITING

Related Publications (10)

• Deuschl G, Herzog J, Kleiner-Fisman G, Kubu C, Lozano AM, Lyons KE, Rodriguez-Oroz MC, Tamma F, Troster AI, Vitek JL, Volkmann J, Voon V. Deep brain stimulation: postoperative issues. Mov Disord. 2006 Jun;21 Suppl 14:S219-37. doi: 10.1002/mds.20957.

  PMID: 16810719 BACKGROUND

• Huys D, Kohl S, Baldermann JC, Timmermann L, Sturm V, Visser-Vandewalle V, Kuhn J. Open-label trial of anterior limb of internal capsule-nucleus accumbens deep brain stimulation for obsessive-compulsive disorder: insights gained. J Neurol Neurosurg Psychiatry. 2019 Jul;90(7):805-812. doi: 10.1136/jnnp-2018-318996. Epub 2019 Feb 15.

  PMID: 30770458 BACKGROUND

• Denys D, Mantione M, Figee M, van den Munckhof P, Koerselman F, Westenberg H, Bosch A, Schuurman R. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch Gen Psychiatry. 2010 Oct;67(10):1061-8. doi: 10.1001/archgenpsychiatry.2010.122.

  PMID: 20921122 BACKGROUND

• Belotto-Silva C, Diniz JB, Malavazzi DM, Valerio C, Fossaluza V, Borcato S, Seixas AA, Morelli D, Miguel EC, Shavitt RG. Group cognitive-behavioral therapy versus selective serotonin reuptake inhibitors for obsessive-compulsive disorder: a practical clinical trial. J Anxiety Disord. 2012 Jan;26(1):25-31. doi: 10.1016/j.janxdis.2011.08.008. Epub 2011 Aug 19.

  PMID: 21907540 BACKGROUND

• Soomro GM, Altman D, Rajagopal S, Oakley-Browne M. Selective serotonin re-uptake inhibitors (SSRIs) versus placebo for obsessive compulsive disorder (OCD). Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD001765. doi: 10.1002/14651858.CD001765.pub3.

  PMID: 18253995 BACKGROUND

• Huang Y, Wang Y, Wang H, Liu Z, Yu X, Yan J, Yu Y, Kou C, Xu X, Lu J, Wang Z, He S, Xu Y, He Y, Li T, Guo W, Tian H, Xu G, Xu X, Ma Y, Wang L, Wang L, Yan Y, Wang B, Xiao S, Zhou L, Li L, Tan L, Zhang T, Ma C, Li Q, Ding H, Geng H, Jia F, Shi J, Wang S, Zhang N, Du X, Du X, Wu Y. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. 2019 Mar;6(3):211-224. doi: 10.1016/S2215-0366(18)30511-X. Epub 2019 Feb 18.

  PMID: 30792114 BACKGROUND

• Kwon JS, Jang JH, Choi JS, Kang DH. Neuroimaging in obsessive-compulsive disorder. Expert Rev Neurother. 2009 Feb;9(2):255-69. doi: 10.1586/14737175.9.2.255.

  PMID: 19210199 BACKGROUND

• Boedhoe PSW, Schmaal L, Abe Y, Alonso P, Ameis SH, Anticevic A, Arnold PD, Batistuzzo MC, Benedetti F, Beucke JC, Bollettini I, Bose A, Brem S, Calvo A, Calvo R, Cheng Y, Cho KIK, Ciullo V, Dallaspezia S, Denys D, Feusner JD, Fitzgerald KD, Fouche JP, Fridgeirsson EA, Gruner P, Hanna GL, Hibar DP, Hoexter MQ, Hu H, Huyser C, Jahanshad N, James A, Kathmann N, Kaufmann C, Koch K, Kwon JS, Lazaro L, Lochner C, Marsh R, Martinez-Zalacain I, Mataix-Cols D, Menchon JM, Minuzzi L, Morer A, Nakamae T, Nakao T, Narayanaswamy JC, Nishida S, Nurmi E, O'Neill J, Piacentini J, Piras F, Piras F, Reddy YCJ, Reess TJ, Sakai Y, Sato JR, Simpson HB, Soreni N, Soriano-Mas C, Spalletta G, Stevens MC, Szeszko PR, Tolin DF, van Wingen GA, Venkatasubramanian G, Walitza S, Wang Z, Yun JY; ENIGMA-OCD Working Group; Thompson PM, Stein DJ, van den Heuvel OA; ENIGMA OCD Working Group. Cortical Abnormalities Associated With Pediatric and Adult Obsessive-Compulsive Disorder: Findings From the ENIGMA Obsessive-Compulsive Disorder Working Group. Am J Psychiatry. 2018 May 1;175(5):453-462. doi: 10.1176/appi.ajp.2017.17050485. Epub 2017 Dec 15.

  PMID: 29377733 BACKGROUND

• Thorsen AL, Hagland P, Radua J, Mataix-Cols D, Kvale G, Hansen B, van den Heuvel OA. Emotional Processing in Obsessive-Compulsive Disorder: A Systematic Review and Meta-analysis of 25 Functional Neuroimaging Studies. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):563-571. doi: 10.1016/j.bpsc.2018.01.009. Epub 2018 Feb 3.

  PMID: 29550459 BACKGROUND

• Stein DJ, Costa DLC, Lochner C, Miguel EC, Reddy YCJ, Shavitt RG, van den Heuvel OA, Simpson HB. Obsessive-compulsive disorder. Nat Rev Dis Primers. 2019 Aug 1;5(1):52. doi: 10.1038/s41572-019-0102-3.

  PMID: 31371720 BACKGROUND

MeSH Terms

Conditions

Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Zhen Wang, Ph.D, M.D

CONTACT

+8602164387250; wangzhen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This is a prospective, multicenter, randomized, open-label, parallel-group study.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: December 14, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

CN (10)