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

NCT ID: NCT05577598

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2026-09-01

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.

Conditions

Obsessive-Compulsive Disorder; Psychiatric Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Implantation of a DBS therapy system

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Implantation of a DBS therapy system

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Christoph Kraus

Ap. Prof. PD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Kraus, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Psychiatry and Psychotherapy

Locations

Medical University of Vienna, Department of Psychiatry and Psychotherapy

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Christoph Kraus, MD PhD

Role: CONTACT

christoph.kraus@muv.ac.at

+43 1 40400 73882

Facility Contacts

Christoph Kraus, MD PhD

Role: primary

Other Identifiers

V4 03062020

Identifier Type: -

Identifier Source: org_study_id