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Tests treatment safety and results for Obsessive - Compulsive Disorder
Official title Efficacy and Influencing Factors of ALIC-NAc Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder
ClinicalTrials.gov ID: NCT07031544
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
You likely can't join 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...
- History of implantation of a cochlear implant, cardiac pacemaker, cardiac defibrillator, prior unilateral or bilateral implantation of similar...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Xinxiang, Henan, China
- Nanchang, Jiangxi, China
- Taiyuan, Shanxi, China
- Mianyang, Sichuan, China
- Shanghai, China
- Tianjin, China
- Tianjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China; Xinxiang, Henan, China; Nanchang, Jiangxi, China; Taiyuan, Shanxi, China; Mianyang, Sichuan, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.