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

NCT05577598 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Obsessive-Compulsive Disorder
  • Psychiatric Disorder

Interventions

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.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Christoph Kraus, MD PhD · Medical University of Vienna, Department of Psychiatry and Psychotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2026-05-01
Completion
2026-09-01
FDA Device
Yes

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05577598 on ClinicalTrials.gov