Obsessive-Compulsive DisorderPhase 1/2NCT01985815
Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)
A Phase 1/2 study testing VC/VS stimulation in people with Obsessive-Compulsive Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- VC/VS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2008to Feb 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
- Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
- Failure of documented trial of cognitive and behavioural therapy
- Duration of illness: min. 5 year
- Y-BOCS at least 30/40.
- Age: 20-65 year
Who cannot join
- DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
- DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
- Present or past history of psychotic symptoms.
- Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
- Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
- Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
- The patient must be juridical free.
Trial locations and contacts
1 site in 1 country.
About this study
In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with different neurological disorders. The results of this novel approach to psychiatric disorders have been optimistic. This study aims to investigate wether or not the distance to target location has an influence on the outcome.
In order to deliver DBS, leads containing four electrodes are implanted into the brain target in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter a triple blind randomised two fazed crossover design of two periods of three months. In both crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the stimulation conditions. These conditions are stimulation ON (at optimal parameters) and stimulation OFF. Stimulation parameters are constant during the entire period. During the second crossover branch, stimulation conditions are reversed for all patients.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- VC/VS stimulation
- Keywords
- obsessive-compulsive disorder, Deep Brain Stimulation, Psychosurgery
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC/VS stimulationDevice
Also called Neurostimulator: Kinetra (Medtronic), Electrode: 3387 (Medtronic)
| Study group | Role | What they receive |
|---|---|---|
| VC/VS stimulation ON followed by OFF | Experimental | triple blind, randomised, two periods of three months Receives: Device: VC/VS stimulation |
| VC/VS stimulation OFF followed by ON | Experimental | triple blind, randomised, two periods of three months Receives: Device: VC/VS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: up to 12 months
Secondary outcomes (8)
Clinical Global Impression (CGI)
Measured: up to 12 months
Global assessment of functioning (GAF)
Measured: up to 12 months
Hamilton scale for anxiety
Measured: up to 12 months
Beck depression inventory
Measured: up to 12 months
Inventory of Depressive Symptoms (IDS)
Measured: up to 12 months
Patient Global Impression (PGI).
Measured: up to 12 months
Symptom Checklist (SCL-90)
Measured: up to 12 months
Quality of Life and Satisfaction Questionnaire (Q-Les-Q)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startMar 2008
- Primary completionFeb 2010
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 Universitaire Ziekenhuizen KU LeuvenThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985815
- Sponsor's protocol ID
- s50927
- Status last verified
- Jun 2013
- First submitted
- 22 Oct 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT01985815
- Acronym / sponsor ID
- s50927
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- obsessive-compulsive disorder, Deep Brain Stimulation, Psychosurgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2010 (actual)
- First posted
- 15 Nov 2013 (estimated)
- 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.
In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with different neurological disorders. The results of this novel approach to psychiatric disorders have been optimistic. This study aims to investigate wether or not the distance to target location has an influence on the outcome.
In order to deliver DBS, leads containing four electrodes are implanted into the brain target in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter a triple blind randomised two fazed crossover design of two periods of three months. In both crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the stimulation conditions. These conditions are stimulation ON (at optimal parameters) and stimulation OFF. Stimulation parameters are constant during the entire period. During the second crossover branch, stimulation conditions are reversed for all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VC/VS stimulation ON followed by OFF | Experimental | Device: VC/VS stimulationtriple blind, randomised, two periods of three months |
| VC/VS stimulation OFF followed by ON | Experimental | Device: VC/VS stimulationtriple blind, randomised, two periods of three months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
- Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
- Failure of documented trial of cognitive and behavioural therapy
- Duration of illness: min. 5 year
- Y-BOCS at least 30/40.
Key exclusion criteria (7 listed)
- DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
- DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
- Present or past history of psychotic symptoms.
- Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
- Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
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 |
|---|---|---|
| VC/VS stimulationAlso: Neurostimulator: Kinetra (Medtronic), Electrode: 3387 (Medtronic) | Device | VC/VS stimulation OFF followed by ON, VC/VS stimulation ON followed by OFF |
Primary outcome
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: up to 12 months
8 secondary outcomes
Clinical Global Impression (CGI)
Time frame: up to 12 months
Global assessment of functioning (GAF)
Time frame: up to 12 months
Hamilton scale for anxiety
Time frame: up to 12 months
Beck depression inventory
Time frame: up to 12 months
Inventory of Depressive Symptoms (IDS)
Time frame: up to 12 months
Patient Global Impression (PGI).
Time frame: up to 12 months
Symptom Checklist (SCL-90)
Time frame: up to 12 months
Quality of Life and Satisfaction Questionnaire (Q-Les-Q)
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VC/VS stimulation in people with Obsessive-Compulsive Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 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: finished, as of the sponsor's last update on 15 Nov 2013. 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: up to 12 months). 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 15 Nov 2013.