Obsessive-Compulsive DisorderNCT04967560
The Efficacy and Safety of ALIC/NAcc-DBS for Treatment-refractory OCD
A study testing deep brain stimulation in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 7 sites in China.
Trial 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… 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 7 sitesChina
- Study dates
- 30 Jul 2021to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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);
- suffered from severe OCD symptoms over 5 years with substantial functional impairment;
- the Y-BOCS total score ≥ 25;
- met the criteria of treatment refractory. Treatment refractory is defined as failed 1) at least three adequate therapeutic trials of serotin reuptake inhibitors (SRIs), with clomipramine being one of the SRIs trials, 2) the use of at least two atypical antipsychotics as augmenting agents, 3) at least 12 sessions of therapist-guided cognitive-behavioral therapy while on a therapeutic dose of an SRIs. These patients have "failed" treatment by demonstrating <25% reduction of Y-BOCS scores or, despite >25% reduction in YBOCS score, by still experiencing significant impairment from their illness.
Who cannot join
- a history of current or past diagnosis of any psychosis according to DSM-5 except for OCD
- any clinical significant neurological disorder, traumatic brain injury, dementia, or medical illness
- any contradiction of neurosurgery
- any current or unstably remitted substance abuse or dependence
- women who are pregnant or preparing for pregnant
- severe suicide risk and tendency according to the investigators' judgements
- participate in any other clinical trials within three months (except for registered studies).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Brains Hospital of Hunan Province
Changsha, Hunan
West China Hospital
Chengdu, Sichuan
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Changhai Hospital
Shanghai, Shanghai Municipality
Huashan Hospital
Shanghai, Shanghai Municipality
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: 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)
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.
Read the 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
- Being tested
- deep brain stimulation
- Keywords
- obsessive-compulsive disorder, deep brain stimulation, anterior limb of internal capsule, nucleus accumbens
- Medical subject headings
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| DBS true-stimulation group | Active comparator | The electrical stimulation will be 'turned-on' immediately after programming in true-stimulation group. Receives: Device: deep brain stimulation |
| DBS sham-stimulation group | Sham comparator | The electrical stimulation will be 'turned-off' after programming in sham-stimulation group. The stimulation will begin until after completing three months of Y-BOCS and CGI assessments Receives: Device: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response rate
Our primary outcome measure was to compare the treatment response rate (TRR) between the active group and sham-controlled group at the end of three months. (TRR is defined as the number of treatment response/the number of group, a ≥35% reduction in Y-BOCS plus CGI=1or2 met the criteria of treatment response). Note: Y-BOCS, Yale-Brown obsessive-compulsive scale; CGI, clinical global impression.
Measured: three month after stimulus
Secondary outcomes (8)
the change scores of Y-BOCS at double-blinded stage
The severity of OCD symptoms was assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). This scale including 10 items, the maximum score is 40. The higher score means the more serious of disease.
Measured: three month after stimulus
the change scores of CGI at double-blinded stage
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 theraputic effect and side effects.
Measured: three month after stimulus
the change scores of HAMD at double-blinded stage
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: three month after stimulus
the change scores of HAMA at double-blinded stage
The Hamilton Anxity 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: three month after stimulus
the change scores of Y-BOCS at open-label stage
The severity of OCD symptoms was assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). This scale including 10 items, the maximum score is 40. The higher score means the more serious of disease.
Measured: six month after stimulus
the change scores of CGI at open-label stage
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 theraputic effect and side effects.
Measured: six month after stimulus
the change scores of HAMD at open-label stage
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: six month after stimulus
the change scores of HAMA at open-label stage
The Hamilton Anxity 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: six month after stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start30 Jul 2021
- Primary completion13 Nov 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- All eligible patients who consent to participation and met all inclusion and exclusion criteria will be randomized to active and sham-stimulation group at post-operative.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Huashan Hospital, The First Affiliated Hospital of Zhengzhou University, Hunan Brain Hospital, First Affiliated Hospital of Kunming Medical University, Changhai Hospital, SceneRay Corporation, Limited
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967560
- Sponsor's protocol ID
- SR1182
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04967560
- Acronym / sponsor ID
- SR1182
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- obsessive-compulsive disorder, deep brain stimulation, anterior limb of internal capsule, nucleus accumbens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- West China Hospital, Huashan Hospital, The First Affiliated Hospital of Zhengzhou University, Hunan Brain Hospital, First Affiliated Hospital of Kunming Medical University, Changhai Hospital, SceneRay Corporation, Limited
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All eligible patients who consent to participation and met all inclusion and exclusion criteria will be randomized to active and sham-stimulation group at post-operative.
| Arm | Type | Receives |
|---|---|---|
| DBS true-stimulation group | Active comparator | Device: deep brain stimulationThe electrical stimulation will be 'turned-on' immediately after programming in true-stimulation group. |
| DBS sham-stimulation group | Sham comparator | Device: deep brain stimulationThe electrical stimulation will be 'turned-off' after programming in sham-stimulation group. The stimulation will begin until after completing three months of Y-BOCS and CGI assessments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18-65 years old;
- a diagnosis of OCD based on The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5);
- suffered from severe OCD symptoms over 5 years with substantial functional impairment;
- the Y-BOCS total score ≥ 25;
- met the criteria of treatment refractory. Treatment refractory is defined as failed 1) at least three adequate therapeutic trials of serotin reuptake inhibitors (SRIs), with clomipramine being one of the SRIs trials, 2) the use of at least two atypical antipsychotics as augmenting agents, 3) at least 12 sessions of therapist-guided cognitive-behavioral therapy while on a therapeutic dose of an SRIs. These patients have "failed" treatment by demonstrating <25% reduction of Y-BOCS scores or, despite >25% reduction in YBOCS score, by still experiencing significant impairment from their illness.
Key exclusion criteria (7 listed)
- a history of current or past diagnosis of any psychosis according to DSM-5 except for OCD
- any clinical significant neurological disorder, traumatic brain injury, dementia, or medical illness
- any contradiction of neurosurgery
- any current or unstably remitted substance abuse or dependence
- women who are pregnant or preparing for pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep brain stimulationBoth 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. | Device | DBS sham-stimulation group, DBS true-stimulation group |
Primary outcome
Treatment response rate
Time frame: three month after stimulus
Our primary outcome measure was to compare the treatment response rate (TRR) between the active group and sham-controlled group at the end of three months. (TRR is defined as the number of treatment response/the number of group, a ≥35% reduction in Y-BOCS plus CGI=1or2 met the criteria of treatment response). Note: Y-BOCS, Yale-Brown obsessive-compulsive scale; CGI, clinical global impression.
8 secondary outcomes
the change scores of Y-BOCS at double-blinded stage
Time frame: three month after stimulus
the change scores of CGI at double-blinded stage
Time frame: three month after stimulus
the change scores of HAMD at double-blinded stage
Time frame: three month after stimulus
the change scores of HAMA at double-blinded stage
Time frame: three month after stimulus
the change scores of Y-BOCS at open-label stage
Time frame: six month after stimulus
the change scores of CGI at open-label stage
Time frame: six month after stimulus
the change scores of HAMD at open-label stage
Time frame: six month after stimulus
the change scores of HAMA at open-label stage
Time frame: six month after stimulus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
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 7 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 7 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: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response rate (time frame: three month after stimulus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.