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

Primary Purpose

Obsessive-Compulsive Disorder, Psychiatric Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Implantation of a DBS therapy system

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring FDG-PET, Deep Brain Stimulation, Brain Glucose Consumption

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of Vienna, Department of Psychiatry and PsychotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Subjects in this arm will receive active stimulation.

Subjects in this arm will receive sham stimulation with DBS being turned off.

Arm Description

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.

Outcomes

Primary Outcome Measures

Change of metabolic rates of glucose response pattern

Secondary Outcome Measures

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

Change in YBOCS scores by active DBS treatment and sham treatment

Comparison of YBOCS scores during active and sham treatment

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

Full Information

NCT ID

NCT05577598

First Posted

September 25, 2022

Last Updated

October 10, 2022

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT05577598

Brief Title

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

Acronym

OCDBS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder, Psychiatric Disorder

Keywords

FDG-PET, Deep Brain Stimulation, Brain Glucose Consumption

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

After 8 weeks of open label DBS optimization and treatment, randomization to 12 weeks active or 12 weeks sham DBS treatment followed by a crossover switch at study week 24 to the opposing condition.

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subjects in this arm will receive active stimulation.

Arm Type

Active Comparator

Arm Description

Arm Title

Subjects in this arm will receive sham stimulation with DBS being turned off.

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Implantation of a DBS therapy system

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of metabolic rates of glucose response pattern

Description

Change of metabolic rates of glucose response pattern

Time Frame

fPET measurements will take place in Week 4 and Week 5 of the trial.

Secondary Outcome Measure Information:

Title

Description

Combination of [18F]FDG-PET data with DTI and resting state fMRI data

Time Frame

Data acquisition will take place during screening and in the first 5 weeks of the study.

Title

Change in YBOCS scores by active DBS treatment and sham treatment

Description

Comparison of YBOCS scores during active and sham treatment

Time Frame

Week 1 to 38

Title

Correlation of metabolic (change in glucose consumption) and connectivity measures (white matter pathways) with clinical outcomes (YBOCS) and neuropsychological tests (SSRT, n-back, WCST)

Description

YBOCS will serve as a marker for clinical outcome

Time Frame

Data acquisition will take place during screening and in Week 1 to Week 38 of the study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Kraus, MD PhD

Phone

+43 1 40400 73882

christoph.kraus@muv.ac.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Kraus, MD PhD

Organizational Affiliation

Medical University of Vienna, Department of Psychiatry and Psychotherapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna, Department of Psychiatry and Psychotherapy

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Kraus, MD PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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