Obsessive-Compulsive DisorderOCDBSNCT05577598
Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder
A study testing Implantation of a DBS therapy system in people with Obsessive-Compulsive Disorder and Psychiatric Disorder, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Psychiatric Disorder
- What is being tested?
- Implantation of a DBS therapy system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Psychiatry and Psychotherapy
Vienna, State of Vienna, 1090
Christoph Kraus, MD PhD
About this study
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.
Read the 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.
- Being tested
- Implantation of a DBS therapy system
- Keywords
- FDG-PET, Deep Brain Stimulation, Brain Glucose Consumption
- Medical subject headings
- Obsessive-Compulsive Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a DBS therapy systemDevice
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 group | Role | What they receive |
|---|---|---|
| Subjects in this arm will receive active stimulation. | Active comparator | 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. Receives: Device: Implantation of a DBS therapy system |
| Subjects in this arm will receive sham stimulation with DBS being turned off. | Sham comparator | 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. Receives: Device: Implantation of a DBS therapy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of metabolic rates of glucose response pattern
Change of metabolic rates of glucose response pattern
Measured: fPET measurements will take place in Week 4 and Week 5 of the trial.
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Data acquisition will take place during screening and in Week 1 to Week 38 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Apr 2022
- Primary completion1 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Kraus, Medical University of Vienna
- Investigators
- Christoph Kraus, MD PhD, Principal investigator, Medical University of Vienna, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577598
- Sponsor's protocol ID
- V4 03062020
- Acronym
- OCDBS
- Status last verified
- Jun 2025
- First submitted
- 25 Sep 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT05577598
- Acronym / sponsor ID
- OCDBS / V4 03062020
- Keywords
- FDG-PET, Deep Brain Stimulation, Brain Glucose Consumption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subjects in this arm will receive active stimulation. | Active comparator | Device: Implantation of a DBS therapy systemThe 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. |
| Subjects in this arm will receive sham stimulation with DBS being turned off. | Sham comparator | Device: Implantation of a DBS therapy systemThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of a DBS therapy systemThe 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. | Device | Subjects in this arm will receive active stimulation., Subjects in this arm will receive sham stimulation with DBS being turned off. |
Primary outcome
Change of metabolic rates of glucose response pattern
Time frame: fPET measurements will take place in Week 4 and Week 5 of the trial.
Change of metabolic rates of glucose response pattern
3 secondary outcomes
Determination of association between metabolic (change in glucose consumption - PET), structural (white matter pathways - DTI) and functional connectivity (resting state fMRI - functional connectivity patterns)
Time frame: 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
Time frame: 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)
Time frame: Data acquisition will take place during screening and in Week 1 to Week 38 of the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Obsessive-Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Kraus, MD PhD principal investigator
Medical University of Vienna, Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of a DBS therapy system in people with Obsessive-Compulsive Disorder and Psychiatric Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph Kraus, MD PhD (+43 1 40400 73882, christoph.kraus@muv.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.