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Deep brain stimulation for obsessive compulsive disorder

Deep brain stimulation for obsessive compulsive disorder

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21232
Enrollment
60
Registered
2019-09-18
Start date
2020-03-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-compulsive disorder

Interventions

DBS targeted to the capsular area around the striatum. DBS consists of two phases: neurosurgical implantation of electrodes and an IPG, followed by optimization of electrical parameters of the pulses

Sponsors

Board of directors, Amsterdam UMC (location AMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Obsessive compulsive disorder according to DSM-5 criteria; 2) At least one of the following conditions is met: a) Y-BOCS score = 25, b) Y-BOCS = 13 in case of solely obsessions or compulsions, or c) 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); 3) Treatment refractoriness as agreed upon by a multidisciplinary team of experts and consultation of an independent expert; 4) age must be 18 years or older; 5) mentally capable to understand the consequences of the procedure and make his or her own choice without coercion; 6) written informed consent.

Exclusion criteria

Exclusion criteria: 1) Primary diagnosis in psychotic spectrum; 2) Unstable multiple sclerosis (MS); 3) Acute brain damage (eg. recent hemorrhage or stroke); 4) General contraindications to have surgery

Design outcomes

Primary

MeasureTime frame
Number of responders after one year of treatment. Response is defined as =35% reduction of the Y-BOCS score compared to baseline.

Secondary

MeasureTime frame
1) Decrease in Y-BOCS score over time; 2) number of reported adverse events;

Contacts

Public ContactIsidoor Bergfeld

Academisch Medisch Centrum, Amsterdam

poli.psychiatrie@amsterdamumc.nl+31208913600

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)