Back to resultsThe Efficacy and Safety of ALIC/NAcc-DBS for Treatment-refractory OCD
Primary Purpose
Obsessive-Compulsive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
deep brain stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring obsessive-compulsive disorder, deep brain stimulation, anterior limb of internal capsule, nucleus accumbens
Eligibility Criteria
Inclusion Criteria:
- 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 20 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.
Exclusion Criteria:
- 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).
Sites / Locations
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Brains Hospital of Hunan ProvinceRecruiting
- Shanghai Mental Health CenterRecruiting
- Changhai HospitalRecruiting
- Huashan HospitalRecruiting
- West China HospitalRecruiting
- The First Affiliated Hospital of Kunming Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
DBS true-stimulation group
DBS sham-stimulation group
Arm Description
The electrical stimulation will be 'turned-on' immediately after programming in true-stimulation group.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04967560
First Posted
July 8, 2021
Last Updated
October 1, 2023
Sponsor
Shanghai Mental Health Center
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
1. Study Identification
Unique Protocol Identification Number
NCT04967560
Brief Title
The Efficacy and Safety of ALIC/NAcc-DBS for Treatment-refractory OCD
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
obsessive-compulsive disorder, deep brain stimulation, anterior limb of internal capsule, nucleus accumbens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Randomization of DBS are blinded to evaluators, participants, and programming doctors. The programming doctors used the specific software to allocated the participants, that software was preset random coding program to randomized allocate the subjects. The DBS interface of all patients is displayed as a true stimulus, but the true impulse was running in the background controlled by the software, so that even the programming doctors could not know the grouping.
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DBS true-stimulation group
Arm Type
Active Comparator
Arm Description
The electrical stimulation will be 'turned-on' immediately after programming in true-stimulation group.
Arm Title
DBS sham-stimulation group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
deep brain stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment response rate
Description
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.
Time Frame
three month after stimulus
Secondary Outcome Measure Information:
Title
the change scores of Y-BOCS at double-blinded stage
Description
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.
Time Frame
three month after stimulus
Title
the change scores of CGI at double-blinded stage
Description
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.
Time Frame
three month after stimulus
Title
the change scores of HAMD at double-blinded stage
Description
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.
Time Frame
three month after stimulus
Title
the change scores of HAMA at double-blinded stage
Description
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.
Time Frame
three month after stimulus
Title
the change scores of Y-BOCS at open-label stage
Description
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.
Time Frame
six month after stimulus
Title
the change scores of CGI at open-label stage
Description
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.
Time Frame
six month after stimulus
Title
the change scores of HAMD at open-label stage
Description
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.
Time Frame
six month after stimulus
Title
the change scores of HAMA at open-label stage
Description
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.
Time Frame
six month after stimulus
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 20 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.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang
Phone
+862164387250
Ext
73516
Email
wangzhen@smhc.org.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-rong Guo
Email
drguohuirong@163.com
Facility Name
Brains Hospital of Hunan Province
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong-xing Huang
Email
2905022134@qq.com
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, Ph.D, M.D
Phone
862164387250
Ext
73516
Email
wangzhen@smhc.org.cn
First Name & Middle Initial & Last Name & Degree
Zhen Wang, Ph.D, M.D
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Wu
Email
wuxi_smmu@sina.com
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Hu
Email
13361913896@163.com
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Li
Email
libinjia@163.com
First Name & Middle Initial & Last Name & Degree
Wei Wang, MD
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-qi Cheng
Email
yuqicheng@126.com
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of ALIC/NAcc-DBS for Treatment-refractory OCD
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