Obsessive Compulsive Disorder (OCD)NCT01879254
Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD).
An observational study of Obsessive Compulsive Disorder (OCD), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
For this human research, 17 treatment-refractory OCD patients who already received DBS implants for treatment refractory OCD between June 1998 and October 2007 will be included. New patients that complete the protocol on "refining the target for DBS in OCD" will be included in this follow-up study as well. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2008to 5 Feb 2015
- Phase
- Observational
- 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
Study population: Patients that have received DBS for OCD will be included in this study.
Who may be able to join
- Patients who have received DBS implantation for the treatment of OCD
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Severe Treatment Refractory Obsessive Compulsive Disorder (OCD).
For this human research, 17 treatment-refractory OCD patients who already received DBS implants for treatment refractory OCD between June 1998 and October 2007 will be included. New patients that complete the protocol on "refining the target for DBS in OCD" will be included in this follow-up study as well. They will be psychiatrically evaluated on regular bases: at least twice yearly in the years two to five after surgery, at least once a year for the years thereafter. The duration of this protocol is indefinite, but spans at least 10 years. The main aim of this study is to investigate the long-term effect of DBS in OCD patients.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Deep Brain Stimulation
- Keywords
- obsessive compulsive disorder (OCD), deep brain stimulation (DBS), psychosurgery, long-term follow-up
- 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 StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| DBS for OCD | Not described Receives: Device: Deep Brain 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 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startFeb 2008
- Primary completion5 Feb 2015
- Study completion5 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT01879254
- Sponsor's protocol ID
- s50928
- Status last verified
- Jul 2024
- First submitted
- 12 Jun 2013
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Severe Treatment Refractory Obsessive Compulsive Disorder (OCD).
- ClinicalTrials.gov ID
- NCT01879254
- Acronym / sponsor ID
- s50928
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- obsessive compulsive disorder (OCD), deep brain stimulation (DBS), psychosurgery, long-term follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2008 (actual)
- Primary completion
- 5 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 17 Jun 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.
For this human research, 17 treatment-refractory OCD patients who already received DBS implants for treatment refractory OCD between June 1998 and October 2007 will be included. New patients that complete the protocol on "refining the target for DBS in OCD" will be included in this follow-up study as well. They will be psychiatrically evaluated on regular bases: at least twice yearly in the years two to five after surgery, at least once a year for the years thereafter. The duration of this protocol is indefinite, but spans at least 10 years. The main aim of this study is to investigate the long-term effect of DBS in OCD patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS for OCD | – | Device: Deep Brain Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have received DBS for OCD will be included in this study.
Key inclusion criteria (1 listed)
- Patients who have received DBS implantation for the treatment of OCD
Key exclusion criteria (1 listed)
- -
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 Stimulation | Device | DBS for OCD |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: up to 10 years
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 10 Jul 2024.
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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?
An observational study of Obsessive Compulsive Disorder (OCD), 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 1 inclusion and 1 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 10 Jul 2024. 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.
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 10 years). 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 10 Jul 2024.