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Obsessive - Compulsive DisorderNCT07031544

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

A study testing deep brain stimulation in people with Obsessive - Compulsive Disorder, run by Shanghai Mental Health Center at 10 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obsessive - Compulsive Disorder
What is being tested?
deep brain stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
10 sitesChina
Study dates
14 Dec 2024to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Inadequate response or intolerance to cognitive behavioral therapy (CBT) consisting of more than 12 sessions conducted concurrently with adequate dosed SSRIs treatment.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhen Wang, Ph.D, M.D contact

+8602164387250 ext. 73516

wangzhen@smhc.org.cn

10 sites in 1 country

China10 sites, 10 recruiting

  • First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

    Yanbin Jia, +8613392489168, yanbinjia2006@163.com

    Recruiting

  • the Third Hospital of Mianyang

    Mianyang, Sichuan

    Mingjin Huang, +8615928728754, huaxijinlan@163.com

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Maorong Hu, +8615070892788, maron13@126.com

    Recruiting

  • Shanghai Mental Health Center

    Shanghai, 200030

    Zhen Wang, Ph.D, M.D, +8602164387250 ext. 73516, wangzhen@smhc.org.cn

    Zhen Wang, Ph.D, M.D

    Recruiting

  • Huashan Hospital

    Shanghai

    Liang Chen, +8602165642662, chenlianghs@126.com

    Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Cuixia An, +8618633889637, acxsunny@sina.com

    Recruiting

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Zhifen Liu, +8613703586547, zhifenliu@sxmuedu.cn

    Recruiting

  • Tianjin Huanhu Hospital

    Tianjin

    Siquan Liang, +8613114862005, liangsiquan@163.com

    Recruiting

  • Tianjin Anding Hospital

    Tianjing

    Jie Li, +8613512410436, jieli@tjmhc.com

    Recruiting

  • The Second Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan

    Chuansheng Wang, +8618537339716, chuansonwang@126.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Influencing Factors of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder

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.

Read more

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
Read the detailed description

This trial adopted a prospective, multicenter, randomized, open-label, parallel-group design. The study population comprised patients with treatment-refractory obsessive-compulsive disorder whose symptoms could not be effectively controlled by pharmacotherapy and psychotherapy. After providing informed consent, participants underwent implantation of an intracranial neurostimulation system, followed by scheduled activation of stimulation post-surgery.

A total of 60 patients were planned for enrollment and randomly assigned to one of three groups based on the timing of stimulation initiation: the one-month group (activation at 30 ± 7 days post-surgery), the two-month group (activation at 60 ± 7 days), and the three-month group (activation at 90 ± 7 days), with 20 participants in each group (1:1:1 allocation). Participants followed the trial schedule for regular assessments. The primary outcome was the difference in Y-BOCS reduction rates among the three groups at 90 ± 7 days after stimulation initiation.

Being tested
deep brain stimulation
Keywords
obsessive-compulsive disorder, deep brain stimulation, anterior limb of internal capsule, nucleus accumbens, activation timing
Medical subject headings
Compulsive Personality Disorder, Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • deep brain stimulationDevice

    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.

Study groups in NCT07031544
Study groupRoleWhat they receive
one-month groupExperimentalDBS activation at 30 ± 7 days post-surgery
Receives: Device: deep brain stimulation
two-month groupExperimentalDBS activation at 60 ± 7 days post-surgery
Receives: Device: deep brain stimulation
three-month groupExperimentalDBS activation at 90 ± 7 days post-surgery
Receives: Device: deep brain stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3-month after DBS activation

Secondary outcomes (4)

  1. the change scores of CGI score

    The Clinical Global Impressions (CGI) is an invaluable tool for monitoring the treatment outcomes of patients. The CGI actually comprises three companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7, (b) change from the initiation of treatment on a similar seven-point scale, and (c) an overall evaluation of the therapeutic effect and side effects.

    Measured: 1, 2 and 3-month after DBS activation

  2. the change scores of HAMD score

    The Hamilton Depression Rating Scale (HAM-D) is used to quantify the severity of symptoms of depression and is one of the most widely used and accepted instruments for assessing depression. It contains 24 items rated on 5-point scale, with the sum of all items making up the total score, yielding total scores from zero to 96. The higher score means more severity of depression symptoms.

    Measured: 1, 2 and 3-month after DBS activation

  3. the change scores of HAMA score

    The Hamilton Anxiety Rating Scale (HAM-A) was one of the first rating scales developed to measure the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety and somatic anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

    Measured: 1, 2 and 3-month after DBS activation

  4. the change of SF-36 score

    The Short Form-36 Health Survey (SF-36) comprises eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health. It also includes one item assessing perceived health change. These domains can be summarized into two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

    Measured: 1, 2 and 3-month after DBS activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start14 Dec 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, multicenter, randomized, open-label, parallel-group study.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07031544
Sponsor's protocol ID
SMHC-DBS-003
Status last verified
Jun 2025
First submitted
12 Jun 2025
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 16810719

  • 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.

    PubMed 30770458

  • 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.

    PubMed 20921122

  • 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.

    PubMed 21907540

  • 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.

    PubMed 18253995

  • 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.

    PubMed 30792114

  • 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.

    PubMed 19210199

  • 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.

    PubMed 29377733

  • 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.

    PubMed 29550459

  • 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.

    PubMed 31371720

Questions about this trial

What is this clinical trial studying?

A study testing deep brain stimulation in people with Obsessive - Compulsive Disorder, run by Shanghai Mental Health Center at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhen Wang, Ph.D, M.D (+8602164387250 ext. 73516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Obsessive-compulsive symptoms improvement (time frame: 3-month after DBS activation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07031544, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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