Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)
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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgia, 3000
- UZ Leuven
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: VC/VS stimulation ON followed by OFF
triple blind, randomised, two periods of three months
|
Andre navn:
|
|
Eksperimentell: VC/VS stimulation OFF followed by ON
triple blind, randomised, two periods of three months
|
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Tidsramme: up to 12 months
|
up to 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Clinical Global Impression (CGI)
Tidsramme: up to 12 months
|
up to 12 months
|
|
Global assessment of functioning (GAF)
Tidsramme: up to 12 months
|
up to 12 months
|
|
Hamilton scale for anxiety
Tidsramme: up to 12 months
|
up to 12 months
|
|
Beck depression inventory
Tidsramme: up to 12 months
|
up to 12 months
|
|
Inventory of Depressive Symptoms (IDS)
Tidsramme: up to 12 months
|
up to 12 months
|
|
Patient Global Impression (PGI).
Tidsramme: up to 12 months
|
up to 12 months
|
|
Symptom Checklist (SCL-90)
Tidsramme: up to 12 months
|
up to 12 months
|
|
Quality of Life and Satisfaction Questionnaire (Q-Les-Q)
Tidsramme: up to 12 months
|
up to 12 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- s50927
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