Obsessive-Compulsive Disorder, Psychiatric Disorder
Conditions
Keywords
FDG-PET, Deep Brain Stimulation, Brain Glucose Consumption
Brief summary
The purpose of this randomized, sham-controlled study is to evaluate the effectiveness of DBS therapy in individuals suffering from severe OCD and to investigate DBS treatment with functional \[18F\]FDG-Brain-PET.
Detailed description
The overall planned study duration per subject is 36 weeks, whereby inclusion is timepoint zero and implantation of DBS will be conducted during the first four study weeks. Patients will then undergo an 8-week open-label active DBS treatment phase followed by a 12-week double blind active or sham treatment and finally a 12-week crossover period with the inverse (active/sham) treatment with at least biweekly study visits. Patients as well as patient handling study psychiatrists will be blinded to active/sham. In case of unbearable aggravation of the symptoms during sham, the sham-period will be shortened to a tolerable length. After maximal 38 weeks all study procedures will be completed, and active DBS treatment will be maintained as long as clinically necessary.
Interventions
DEVICEImplantation of a DBS therapy system
The system is called Reclaim DBS Therapy for OCD und is marketed by Medtronic (Minneapolis, Minnesota). It has a HDE status by the FDA. The system consists of two quadripolar electrodes (Medtronic Reclaim DBS) as well as a generator (Medtronic Activa PC), which will be implanted into a subcutaneous pocket below the clavicula.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
After 8 weeks of open label DBS optimization and treatment, randomization to 12 weeks active or 12 weeks sham DBS treatment followed by a crossover switch at study week 24 to the opposing condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* a score of 25 or higher on the Yale-Brown Obsessive Compulsive Scale * previous failure to respond to at least two medication trials with serotonin reuptake inhibitors at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each. * at least one trial with tricyclic medication at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each. * at least one trial of augmentation with antipsychotic medication, lithium, a benzodiazepine or buspirone * at least on trial of psychotherapy (cognitive behavioral therapy or comparable techniques) for at least 20 sessions * ability to provide written informed consent
Exclusion criteria
* any history of current or past psychotic disorder * a manic episode within the preceding three years * any current clinically significant medical or neurological disorder, that is a contraindication against DBS * any disease that could lead to an altered glucose reactivity (e.g. diabetes) * any clinically significant preoperative MRI abnormality or inability to undergo presurgical MRI * current or unstable remitted substance abuse or dependence except nicotine * pregnancy or high risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception * Any current severe personality disorder except comorbid anankastic personality disorder * Inability to follow the study protocol or adhere to operational requirements * Current and unstable suicidality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of metabolic rates of glucose response pattern | fPET measurements will take place in Week 4 and Week 5 of the trial. | Change of metabolic rates of glucose response pattern |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of association between metabolic (change in glucose consumption - PET), structural (white matter pathways - DTI) and functional connectivity (resting state fMRI - functional connectivity patterns) | Data acquisition will take place during screening and in the first 5 weeks of the study. | Combination of \[18F\]FDG-PET data with DTI and resting state fMRI data |
| Change in YBOCS scores by active DBS treatment and sham treatment | Week 1 to 38 | Comparison of YBOCS scores during active and sham treatment |
| Correlation of metabolic (change in glucose consumption) and connectivity measures (white matter pathways) with clinical outcomes (YBOCS) and neuropsychological tests (SSRT, n-back, WCST) | Data acquisition will take place during screening and in Week 1 to Week 38 of the study. | YBOCS will serve as a marker for clinical outcome |
Countries
Austria
Contacts
Primary ContactChristoph Kraus, MD PhD
Outcome results
None listed