Clinical trial NCT05577598: Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder
Official title: Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Psychiatric Disorder
Keywords: FDG-PET
Deep Brain Stimulation
Brain Glucose Consumption
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of metabolic rates of glucose response pattern
timeFrame: fPET measurements will take place in Week 4 and Week 5 of the trial.
Secondary outcomes:
measure: Determination of association between metabolic (change in glucose consumption - PET), structural (white matter pathways - DTI) and functional connectivity (resting state fMRI - functional connectivity patterns)
timeFrame: Data acquisition will take place during screening and in the first 5 weeks of the study.
measure: Change in YBOCS scores by active DBS treatment and sham treatment
timeFrame: Week 1 to 38
measure: Correlation of metabolic (change in glucose consumption) and connectivity measures (white matter pathways) with clinical outcomes (YBOCS) and neuropsychological tests (SSRT, n-back, WCST)
timeFrame: Data acquisition will take place during screening and in Week 1 to Week 38 of the study.
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Psychiatry and Psychotherapy
Study officials:
affiliation: Medical University of Vienna, Department of Psychiatry and Psychotherapy
name: Christoph Kraus, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: