Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder

Launched by MEDICAL UNIVERSITY OF VIENNA · Oct 10, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how effective a treatment called Deep Brain Stimulation (DBS) is for people with severe Obsessive-Compulsive Disorder (OCD). The researchers want to understand how DBS affects brain activity by using a special imaging technique called PET, which helps visualize how glucose (a type of sugar that the brain uses for energy) is used in the brain during the treatment. The study is currently looking for participants who meet specific criteria, including adults aged 18 to 65 who have not responded well to multiple medication treatments for OCD and have undergone therapy.

To be eligible, participants must have a certain level of OCD severity and have tried various medications and therapies without success. However, those with a history of certain mental health issues, significant medical conditions, or those who are pregnant or at risk of pregnancy cannot participate. If someone joins the study, they can expect to receive either the active treatment or a placebo (a treatment that looks the same but has no active effect) and will be closely monitored. This research aims to provide better treatment options for individuals struggling with OCD.

Gender

ALL

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