DBS leads to a symptom reduction in patients with OCD
Bron
Verkorte titel
Aandoening
Obsessive-compulsive disorder
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Number of responders after one year of treatment. Response is defined as ≥35% reduction of the Y-BOCS score compared to baseline.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
DBS leads to a symptom reduction in patients with OCD
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL8034 |
Ander register | METC AMC : METC2019_230 |