Establishing efficacy and safety of the electrodes and implantable pulse generators (IPGs), which are used for deep brain stimulation (DBS) in patients with obsessive-compulsive disorder (OCD).
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in obsessive-compulsive symptomes (measured as a change of Y-BOCS score
compared to baseline)
Secondary outcome
Depressive symptoms (measured with the Hamilton Depression Rating Scale)
Adverse events
DBS settings
Medication use
Background summary
Deep brain stimulation (DBS) is an effective treatment for obsessive-compulsive
disorder (OCD). However, the DBS system used in the Netherlands carries a CE
mark for movement disorders, but not for OCD. Therefore, this study aims to
register the long term efficacy and safety of the DBS system.
Study objective
Establishing efficacy and safety of the electrodes and implantable pulse
generators (IPGs), which are used for deep brain stimulation (DBS) in patients
with obsessive-compulsive disorder (OCD).
Study design
Adult patients with OCD, who have responded insufficiently to medication and
psychotherapy, are included in a prospective cohort study. The first year of
the treatment, the patient is measured 5 times: before DBS surgery (T0), after
surgery with stimulation still off (T1), after optimizing DBS settings (T2),
after addition of cognitive behavioral therapy (T3), and one year after DBS
surgery (T4). After the first year, the patient is asked to partcipate in a
database study. The patient is followed up once a year for the duration of the
treatment (LTx) or until OCD is added as an indication to the CE mark of the
concerning devices.
Intervention
The patients are treated with deep brain stimulation.
Study burden and risks
In the literature, a low occurrence of severe adverse events is associated with
the surgery, device or stimulation. A high occurrence of mild or transient
adverse events associated with stimulation has been described. The latter could
always be resolved by parameter adjustment or disappeared spontaneously.
Participation in the clinical investigation only concerns the administration of
semi-structured interviews. This poses no additional risks over those
associated with the treatment or device.
Meibergdreef 5
Amsterdam 1105 AZ
NL
Meibergdreef 5
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
We will include patients who meet the following inclusion criteria:
- Obsessive compulsive disorder according to DSM-5 criteria
- At least one of the following conditions is met: 1) Y-BOCS score >= 28; 2)
Y--BOCS >= 14 in case of solely obsessions or compulsions; 3) Suffering from
obsessions or compulsions for at least 8 hours a day (i.e. a score of 4 on item
1 or item 6 of the Y-BOCS)
- Treatment refractoriness is defined as failure of all of the following: 1) at
least 2 different types of SSRI*s; 2) clomipramine; 3) addition of an
antipsychotic to either an SSRI or clomipramine; 4) an adequate trial of
cognitive-behavorial therapy given by a therapist who has experience with OCD;
all treatments should be given at therapeutic dosages for adequate duration. On
clinical grounds, exceptions to this definition are allowed, but only after
consultation with the coordinating center.
- Age: 18 years or older
- Motivated and capable to make the frequent visits to the outpatient clinic,
which are necessary for parameter optimization and the CBT.
- Mentally capable to understand the consequences of the procedure and make his
or her own choice without coercion
Exclusion criteria
- Primary diagnosis in psychotic spectrum
- Unstable multiple sclerosis (MS)
- Acute brain damage (eg. recent hemorrhage or stroke)
- General contraindications to have surgery
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71290.018.19 |
| Other | NL8034 |