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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

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.

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 groups in NCT01985815
Study groupRoleWhat they receive
VC/VS stimulation ON followed by OFFExperimentaltriple blind, randomised, two periods of three months
Receives: Device: VC/VS stimulation
VC/VS stimulation OFF followed by ONExperimentaltriple 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.

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

    Measured: up to 12 months

Secondary outcomes (8)

  1. Clinical Global Impression (CGI)

    Measured: up to 12 months

  2. Global assessment of functioning (GAF)

    Measured: up to 12 months

  3. Hamilton scale for anxiety

    Measured: up to 12 months

  4. Beck depression inventory

    Measured: up to 12 months

  5. Inventory of Depressive Symptoms (IDS)

    Measured: up to 12 months

  6. Patient Global Impression (PGI).

    Measured: up to 12 months

  7. Symptom Checklist (SCL-90)

    Measured: up to 12 months

  8. 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.

  1. First posted15 Nov 2013 (estimated)
  2. Study startMar 2008
  3. Primary completionFeb 2010

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT01985815.

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.

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