ClinicalTrials.gg
CompletedNCT01879254Updated Jul 10, 2024

Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD).

An observational study in Obsessive Compulsive Disorder (OCD), sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obsessive Compulsive Disorder (OCD)

Keywords

  • obsessive compulsive disorder (OCD)
  • deep brain stimulation (DBS)
  • psychosurgery
  • long-term follow-up
03

In context

Obsessive-Compulsive Disorder

626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.

This study's enrollment of 30 is below the median of 133 across 86 observational studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients that have received DBS for OCD will be included in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who have received DBS implantation for the treatment of OCD

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • DBS for OCD

    Device: Deep Brain Stimulation

Interventions

  • DeviceDeep Brain Stimulation
06

What researchers measure

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: up to 10 years

07

Study locations

1 site
  • UZ Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2008 to primary completion in Feb 2015, 84 months.

Of 26 observational studies under Obsessive-Compulsive Disorder, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 84. This study's 84 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2013
First posted
Jun 17, 2013
StartActual
Feb 2008
Primary completionActual
Feb 5, 2015
CompletionActual
Feb 5, 2015
Last update
Jul 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01879254
Responsible party
Sponsor
First posted
Jun 17, 2013
Start date
Feb 2008
Primary completion
Feb 5, 2015
Completion
Feb 5, 2015
Last update
Jul 10, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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