Obsessive Compulsive DisorderNCT00724490
Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)
A study testing Deep Brain Stimulation in people with Obsessive Compulsive Disorder, run by University of Cologne at 1 site in Germany.
Trial summary
The purpose of the study was to evaluate whether a unilateral Deep Brain Stimulation of the right Nucleus Accumbens could lead to a more than 35% reduction of symptoms in patients with a treatment resistant Obsessive Compulsive Disorder within two years. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2004to Feb 2008
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis
- severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale
- course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance)
- treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response prevention" of a minimum of 20 sessions with a documented lack of efficiency
- the ability to give written and informed consent
Who cannot join
- co-morbid psychotic disorder according to DSM-IV criteria
- suicidal tendencies in the last 6 months
- history of cerebral trauma
- clinically relevant internal or neurological disorder
- substance misuse or dependence in the last six months
- ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS
- pregnancy
- lactation period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, University of Cologne
Cologne, North Rhine-Westphalia, 50924
About this study
Official title: Unilateral Deep Brain Stimulation of the Nucleus Accumbens in Patients With Treatment Resistant Obsessive Compulsive Disorder
The purpose of the study was to evaluate whether a unilateral Deep Brain Stimulation of the right Nucleus Accumbens could lead to a more than 35% reduction of symptoms in patients with a treatment resistant Obsessive Compulsive Disorder within two years.
Read the detailed description
From the late ninety's on, a few work groups published the case series of patients with treatment resistant OCD undergoing deep brain stimulation (DBS). This stereotactical method involves surgically implanted electrodes and previously has been used primarily for the treatment of Parkinson's disease and tremor.
In almost all reported cases, a bilateral stimulation in the anterior limb of the internal capsule (ALIC was applied. However, the electrode designs between the groups varied and in some cases the stimulation area was extended to the adjacent ventral striatal regions including the nucleus accumbens (NAC).
Cortical-striate-thalami-cortical (CSTC) circuits are supported to be implicated in the pathogenesis underlying OCD caused by a failure of inhibition of the ventral striatum. Together with other structures the nucleus accumbens forms the ventral striatum. Because of the predominant role of the NAC to exert modulatory effects within these circuits we considered it to provide a promising target location for DBS.
Moreover the NAC ventrally borders with the anterior limb of the internal capsule and the subventricular lateral fundus of the nucleus accumbens is even permeated in rostral sections by numerous internal capsule fiber bundles. It was therefore to be expected that the electrode trajectories and stimulation target selected by us additionally would have an effect on the fibre systems of the internal capsule.
The NAC had been introduced as primary target for DBS in treatment resistant OCD by our group. Pilot series showed that the right stimulation of the NAC yielded the best results, whereas bilateral stimulation showed no additional benefit.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, Obsessive Compulsive Disorder, Nucleus Accumbens
- 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.
Deep Brain StimulationProcedure or surgery
Also called Model 3387 DBS Lead, Medtronic, Minneapolis, USA
Unilateral Deep Brain Stimulation in the right Nucleus Accumbens
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale
Measured: Baseline (preoperative), 1week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary outcomes (1)
Beck Depression Inventory
Measured: Baseline (preoperative), 1 week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startFeb 2004
- Primary completionSep 2007
- Study completionFeb 2008
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Joachim Klosterkötter, MD, Principal investigator, Department of Psychiatry, Head of Department, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724490
- Sponsor's protocol ID
- Ocdbs-Psy-120304
- Status last verified
- Jul 2008
- First submitted
- 25 Jul 2008
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Deep Brain Stimulation of the Nucleus Accumbens in Patients With Treatment Resistant Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00724490
- Acronym / sponsor ID
- Ocdbs-Psy-120304
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Deep Brain Stimulation, Obsessive Compulsive Disorder, Nucleus Accumbens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 29 Jul 2008 (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.
The purpose of the study was to evaluate whether a unilateral Deep Brain Stimulation of the right Nucleus Accumbens could lead to a more than 35% reduction of symptoms in patients with a treatment resistant Obsessive Compulsive Disorder within two years.
Detailed description
From the late ninety's on, a few work groups published the case series of patients with treatment resistant OCD undergoing deep brain stimulation (DBS). This stereotactical method involves surgically implanted electrodes and previously has been used primarily for the treatment of Parkinson's disease and tremor.
In almost all reported cases, a bilateral stimulation in the anterior limb of the internal capsule (ALIC was applied. However, the electrode designs between the groups varied and in some cases the stimulation area was extended to the adjacent ventral striatal regions including the nucleus accumbens (NAC).
Cortical-striate-thalami-cortical (CSTC) circuits are supported to be implicated in the pathogenesis underlying OCD caused by a failure of inhibition of the ventral striatum. Together with other structures the nucleus accumbens forms the ventral striatum. Because of the predominant role of the NAC to exert modulatory effects within these circuits we considered it to provide a promising target location for DBS.
Moreover the NAC ventrally borders with the anterior limb of the internal capsule and the subventricular lateral fundus of the nucleus accumbens is even permeated in rostral sections by numerous internal capsule fiber bundles. It was therefore to be expected that the electrode trajectories and stimulation target selected by us additionally would have an effect on the fibre systems of the internal capsule.
The NAC had been introduced as primary target for DBS in treatment resistant OCD by our group. Pilot series showed that the right stimulation of the NAC yielded the best results, whereas bilateral stimulation showed no additional benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis
- severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale
- course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance)
- treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response prevention" of a minimum of 20 sessions with a documented lack of efficiency
- the ability to give written and informed consent
Key exclusion criteria (8 listed)
- co-morbid psychotic disorder according to DSM-IV criteria
- suicidal tendencies in the last 6 months
- history of cerebral trauma
- clinically relevant internal or neurological disorder
- substance misuse or dependence in the last six months
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 |
|---|---|---|
| Deep Brain StimulationAlso: Model 3387 DBS Lead, Medtronic, Minneapolis, USAUnilateral Deep Brain Stimulation in the right Nucleus Accumbens | Procedure or surgery | – |
Primary outcome
Yale-Brown Obsessive Compulsive Scale
Time frame: Baseline (preoperative), 1week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
1 secondary outcome
Beck Depression Inventory
Time frame: Baseline (preoperative), 1 week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 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 29 Jul 2008.
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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.
Joachim Klosterkötter, MD principal investigator
Department of Psychiatry, Head of Department, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Obsessive Compulsive Disorder, run by University of Cologne at 1 site in Germany.
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 5 inclusion and 8 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 29 Jul 2008. 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 Germany. 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.
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 (time frame: Baseline (preoperative), 1week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 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 29 Jul 2008.