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

Sponsor
Medical University of Vienna
Study ID
NCT05577598
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder
  • Psychiatric Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Implantation of a DBS therapy system — 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.

Study Details

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.

Key Dates

First listed
Oct 13, 2022
Start date
Apr 1, 2022
Status verified
Jun 2025
Primary completion
May 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change of metabolic rates of glucose response pattern [ Time Frame: fPET measurements will take place in Week 4 and Week 5 of the trial. ]

Central Contacts

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