RecruitingNot ApplicableNCT05577598

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

Sponsor

Medical University of Vienna

Enrollment

8 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Psychiatric Disorder Obsessive-Compulsive Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria10

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

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.