Obsessive Compulsive DisorderPhase 4NCT01135745
Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)
A Phase 4 study testing Reclaim® Deep Brain Stimulation in people with Obsessive Compulsive Disorder, run by MedtronicNeuro at 8 sites in 7 countries.
Trial summary
The purpose of the study is to monitor the safety and performance of Reclaim® Deep Brain Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive Compulsive Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Reclaim® Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Apr 2010to May 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signing and dating of Informed Consent
- male and female patients at least 18 years of age
- diagnosis of Obsessive Compulsive Disorder
- meeting the definition of treatment resistance
Who cannot join
- Axis-I disorder primary to OCD
- contraindication to implantation
- suicide risk
- risk of non-compliance
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Spain2 sites
Hospital Ciutat Sanitaria I Universitaria de Bellvitge
Barcelona, 08907
Hospital Virgen de las Nieves
Granada, 18014
Germany1 site
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, 23538
About this study
Official title: Reclaim® Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Post-Market Clinical Follow-up Study (OCD PMCF)
The purpose of the study is to monitor the safety and performance of Reclaim® Deep Brain Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive Compulsive Disorder.
Read the detailed description
OCD is an anxiety disorder characterized by intrusive thoughts or images (obsessions), which increase anxiety, commonly accompanied by repetitive or ritualistic actions (compulsions), which decrease anxiety. The most frequent symptoms are contamination concerns with consequent washing or concerns about harm to self or others with consequent checking.
Although many OCD patients benefit from pharmacotherapy or CBT, between 7% and 10% of OCD patients fail to benefit from these standard treatments and may be considered treatment-resistant with a chronic deteriorating course. The most severely afflicted and disabled of these patients may be indicated for neurosurgical treatments, often considered as a therapy of last resort.
Neurosurgical procedures currently used in the treatment of severe, treatment-resistant OCD include anterior cingulotomy, subcaudate tractotomy, limbic leucotomy (which is a combination of the first two procedures) and anterior capsulotomy. The commonality between the different neurosurgical procedures is the irreversible lesioning of bilateral neuroanatomical structures and/or interconnecting pathways that are believed to be involved in the control of affect and limbic function.
An alternative neurosurgical treatment option to the standard lesioning procedures is Reclaim® Deep Brain Stimulation (DBS) Therapy for OCD, which received CE mark in July 2009.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Reclaim® Deep Brain Stimulation
- 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.
Reclaim® Deep Brain StimulationDevice
Implant of leads in pre-defined brain area; implant of neurostimulators
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation Therapy for OCD | Experimental | Reclaim® DBS Therapy uses thin wires to deliver electric current (stimulation) to a very specific target in the brain. These wires are implanted surgically. They are attached to internal neurostimulators implanted under the skin of the chest below the collarbone, similar to cardiac pacemakers, or in the abdominal wall. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. Receives: Device: Reclaim® Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of Adverse Events related to implant procedures, device or stimulation
Prior to any other study procedures Adverse Events will be assessed at every study visit, i.e. after assessment at the baseline visit this will be implant visit, first parameter selection visit and regular visits after 3, 6, and 12 months treatment. AEs will also be collected at all unscheduled visits prior to all other assessments. AEs and stimulation effects will be categorized and recorded in the patient CRF. An independent clinical event committee will review and adjudicate AEs on a regular basis throughout the study.
Measured: 12 months
Secondary outcomes (1)
To characterize improvement from baseline in OCD symptoms assessed by YBOCS.
YBOCS score is taken at baseline and then at post-implant visits after 3, 6 and 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Loes Gabriels, MD PhD MsEng, Principal investigator, Professor of Psychiatry at UZ LeuvenAndreas Wahl-Kordon, MD, Principal investigator, University Hospital LübeckLudger Tebartz van Elst, MD, Principal investigator, University Hospital FreiburgJose M Menchon, MD, Principal investigator, University Hospital Bellvitge BarcelonaAntonio Higueras, MD, Principal investigator, University Hospital GranadaOrsola Gambini, MD, Principal investigator, University Hospital San Paolo MilanMichael Schüpbach, MD, Principal investigator, Insel Gruppe AG, University Hospital BernSiegried Kasper, MD, Principal investigator, Department of Psychiatry and Psychotherapy Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135745
- Sponsor's protocol ID
- OCD PMCF Study 1.02.7003
- Status last verified
- Jan 2018
- First submitted
- 5 May 2010
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rauch SL, Dougherty DD, Malone D, Rezai A, Friehs G, Fischman AJ, Alpert NM, Haber SN, Stypulkowski PH, Rise MT, Rasmussen SA, Greenberg BD. A functional neuroimaging investigation of deep brain stimulation in patients with obsessive-compulsive disorder. J Neurosurg. 2006 Apr;104(4):558-65. doi: 10.3171/jns.2006.104.4.558.
PubMed 16619660
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reclaim® Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Post-Market Clinical Follow-up Study (OCD PMCF)
- ClinicalTrials.gov ID
- NCT01135745
- Acronym / sponsor ID
- OCD PMCF Study 1.02.7003
- Conditions
- Obsessive Compulsive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Jun 2010 (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 is to monitor the safety and performance of Reclaim® Deep Brain Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive Compulsive Disorder.
Detailed description
OCD is an anxiety disorder characterized by intrusive thoughts or images (obsessions), which increase anxiety, commonly accompanied by repetitive or ritualistic actions (compulsions), which decrease anxiety. The most frequent symptoms are contamination concerns with consequent washing or concerns about harm to self or others with consequent checking.
Although many OCD patients benefit from pharmacotherapy or CBT, between 7% and 10% of OCD patients fail to benefit from these standard treatments and may be considered treatment-resistant with a chronic deteriorating course. The most severely afflicted and disabled of these patients may be indicated for neurosurgical treatments, often considered as a therapy of last resort.
Neurosurgical procedures currently used in the treatment of severe, treatment-resistant OCD include anterior cingulotomy, subcaudate tractotomy, limbic leucotomy (which is a combination of the first two procedures) and anterior capsulotomy. The commonality between the different neurosurgical procedures is the irreversible lesioning of bilateral neuroanatomical structures and/or interconnecting pathways that are believed to be involved in the control of affect and limbic function.
An alternative neurosurgical treatment option to the standard lesioning procedures is Reclaim® Deep Brain Stimulation (DBS) Therapy for OCD, which received CE mark in July 2009.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation Therapy for OCD | Experimental | Device: Reclaim® Deep Brain StimulationReclaim® DBS Therapy uses thin wires to deliver electric current (stimulation) to a very specific target in the brain. These wires are implanted surgically. They are attached to internal neurostimulators implanted under the skin of the chest below the collarbone, similar to cardiac pacemakers, or in the abdominal wall. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- signing and dating of Informed Consent
- male and female patients at least 18 years of age
- diagnosis of Obsessive Compulsive Disorder
- meeting the definition of treatment resistance
Key exclusion criteria (4 listed)
- Axis-I disorder primary to OCD
- contraindication to implantation
- suicide risk
- risk of non-compliance
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 |
|---|---|---|
| Reclaim® Deep Brain StimulationImplant of leads in pre-defined brain area; implant of neurostimulators | Device | Deep Brain Stimulation Therapy for OCD |
Primary outcome
Characterization of Adverse Events related to implant procedures, device or stimulation
Time frame: 12 months
Prior to any other study procedures Adverse Events will be assessed at every study visit, i.e. after assessment at the baseline visit this will be implant visit, first parameter selection visit and regular visits after 3, 6, and 12 months treatment. AEs will also be collected at all unscheduled visits prior to all other assessments. AEs and stimulation effects will be categorized and recorded in the patient CRF. An independent clinical event committee will review and adjudicate AEs on a regular basis throughout the study.
1 secondary outcome
To characterize improvement from baseline in OCD symptoms assessed by YBOCS.
Time frame: 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 23 Jan 2018.
- Background: PubMed 16619660Rauch SL, Dougherty DD, Malone D, Rezai A, Friehs G, Fischman AJ, Alpert NM, Haber SN, Stypulkowski PH, Rise MT, Rasmussen SA, Greenberg BD. A functional neuroimaging investigation of deep brain stimulation in patients with obsessive-compulsive disorder. J Neurosurg. 2006 Apr;104(4):558-65. doi: 10.3171/jns.2006.104.4.558.
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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.
Loes Gabriels, MD PhD MsEng principal investigator
Professor of Psychiatry at UZ Leuven
Andreas Wahl-Kordon, MD principal investigator
University Hospital Lübeck
Ludger Tebartz van Elst, MD principal investigator
University Hospital Freiburg
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reclaim® Deep Brain Stimulation in people with Obsessive Compulsive Disorder, run by MedtronicNeuro at 8 sites in 7 countries.
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 4 inclusion and 4 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Belgium, Germany, Israel, Italy and 2 more countries. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Characterization of Adverse Events related to implant procedures, device or stimulation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135745, which also lists 1 linked publication.
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 23 Jan 2018.