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

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.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder; Psychiatric Disorder
• Intervention / Treatment: Device: Implantation of a DBS therapy system

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.

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Kraus, MD PhD; Phone Number: +43 1 40400 73882; Email: christoph.kraus@muv.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna, Department of Psychiatry and Psychotherapy
    • Contact: Christoph Kraus, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subjects in this arm will receive active stimulation.; The Medtronic DBS system will be implanted in subjects in both study arms. Stimulation will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.	Device: Implantation 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.
Sham Comparator: Subjects in this arm will receive sham stimulation with DBS being turned off.; The Medtronic DBS system will be implanted in subjects in both study arms. Stimulation will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.	Device: Implantation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of metabolic rates of glucose response pattern	Change of metabolic rates of glucose response pattern	fPET measurements will take place in Week 4 and Week 5 of the trial.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of association between metabolic (change in glucose consumption - PET), structural (white matter pathways - DTI) and functional connectivity (resting state fMRI - functional connectivity patterns)	Combination of [18F]FDG-PET data with DTI and resting state fMRI data	Data acquisition will take place during screening and in the first 5 weeks of the study.
Change in YBOCS scores by active DBS treatment and sham treatment	Comparison of YBOCS scores during active and sham treatment	Week 1 to 38
Correlation of metabolic (change in glucose consumption) and connectivity measures (white matter pathways) with clinical outcomes (YBOCS) and neuropsychological tests (SSRT, n-back, WCST)	YBOCS will serve as a marker for clinical outcome	Data acquisition will take place during screening and in Week 1 to Week 38 of the study.

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Christoph Kraus, MD PhD, Medical University of Vienna, Department of Psychiatry and Psychotherapy

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; FDG-PET; Brain Glucose Consumption
• Additional Relevant MeSH Terms: Behavioral Symptoms; Personality Disorders; Anxiety Disorders; Problem Behavior; Mental Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: V4 03062020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes