No registrations found.
ID
Source
Brief title
Health condition
Obsessive-compulsive disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of responders after one year of treatment. Response is defined as ≥35% reduction of the Y-BOCS score compared to baseline.
Secondary outcome
1) Decrease in Y-BOCS score over time; 2) number of reported adverse events;
Background summary
Objective: Establishing efficacy and safety of the electrodes and implantable pulse generators (IPGs), which are used for deep brain stimulation (DBS) in patients with obsessive-compulsive disorder (OCD).
Study design: Patients with treatment-resistant OCD are enrolled in a multicenter, prospective cohort study. The first year of the treatment, the patient is measured 5 times: before DBS surgery (T0), after surgery with stimulation still off (T1), after optimizing DBS settings (T2), after addition of cognitive behavioral therapy (T3), and one year after DBS surgery (T4). After the first year, the patient is measured once a year for the duration of the treatment (LTx) or until OCD is added as an indication to the CE mark of the concerning devices.
Inclusion criteria: 1) Obsessive compulsive disorder according to DSM-5 criteria; 2) At least one of the following conditions is met: a) Y-BOCS score ≥ 25, b) Y-BOCS ≥ 13 in case of solely obsessions or compulsions, or c) Suffering from obsessions or compulsions for at least 8 hours a day (i.e. a score of 4 on item 1 or item 6 of the Y-BOCS); 3) Treatment refractoriness as agreed upon by a multidisciplinary team of experts and consultation of an independent expert; 4) age must be 18 years or older; 5) mentally capable to understand the consequences of the procedure and make his or her own choice without coercion; 6) written informed consent.
Exclusion criteria: 1) Primary diagnosis in psychotic spectrum; 2) Unstable multiple sclerosis (MS); 3) Acute brain damage (eg. recent hemorrhage or stroke); 4) General contraindications to have surgery
Sample size: This study concerns a registration study to monitor efficacy and safety until OCD is added as an indication to the CE mark of the concerning medical devices. Therefore, all eligible patients with OCD for deep brain stimulation are included. A sample size calculation is not applicable.
Intervention: DBS targeted to the capsular area around the striatum. DBS consists of two phases: neurosurgical implantation of electrodes and an IPG, followed by optimization of electrical parameters of the pulses given off by the electrodes (eg. voltage, frequency or pulse width).
Primary study outcome: Number of responders after one year of treatment. Response is defined as ≥35% reduction of the Y-BOCS score compared to baseline.
Study objective
DBS leads to a symptom reduction in patients with OCD
Study design
The first year of the treatment, the patient is measured 5 times: before DBS surgery (T0), after surgery with stimulation still off (T1), after optimizing DBS settings (T2), after addition of cognitive behavioral therapy (T3), and one year after DBS surgery (T4). After the first year, the patient is measured once a year for the duration of the treatment (LTx) or until OCD is added as an indication to the CE mark of the concerning devices.
Intervention
DBS targeted to the capsular area around the striatum. DBS consists of two phases: neurosurgical implantation of electrodes and an IPG, followed by optimization of electrical parameters of the pulses given off by the electrodes (eg. voltage, frequency or pulse width).
Inclusion criteria
1) Obsessive compulsive disorder according to DSM-5 criteria; 2) At least one of the following conditions is met: a) Y-BOCS score ≥ 25, b) Y-BOCS ≥ 13 in case of solely obsessions or compulsions, or c) Suffering from obsessions or compulsions for at least 8 hours a day (i.e. a score of 4 on item 1 or item 6 of the Y-BOCS); 3) Treatment refractoriness as agreed upon by a multidisciplinary team of experts and consultation of an independent expert; 4) age must be 18 years or older; 5) mentally capable to understand the consequences of the procedure and make his or her own choice without coercion; 6) written informed consent.
Exclusion criteria
1) Primary diagnosis in psychotic spectrum; 2) Unstable multiple sclerosis (MS); 3) Acute brain damage (eg. recent hemorrhage or stroke); 4) General contraindications to have surgery
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8034 |
| Other | METC AMC : METC2019_230 |