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Cyclic deep brain stimulation for obsessive-compulsive disorder

Completed
Conditions
obsessive-compulsive disorder
OCD
10002861
10052863
Registration Number
NL-OMON55421
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
16
Inclusion Criteria

1) Subject has a primary diagnosis of OCD, which is treated with deep brain
stimulation at the AMC.
2) Subject has completed the period of optimization of DBS settings.
3) Subject has responded to DBS-treatment, defined as an improvement of >25% in
Y-BOCS at last follow-up compared to the pre-surgical baseline.
4) Subject has provided informed consent.

Exclusion Criteria

Subject is unwilling or unable to comply with all study-required follow-up
evaluations.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>1) Clinician rated symptom scales: Yale-Brown Obsessive-Compulsive Scale<br /><br>(Y-BOCS)<br /><br>2) Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS)<br /><br>4) battery power and charging frequency<br /><br>5) adverse events</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1) Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS)<br /><br>2) battery power and battery usage<br /><br>3) adverse events1) subtests of the Cambridge Neuropsychological Test Automated<br /><br>Battery (CANTAB) to assess cognitive functions<br /><br>4) resting state scalp EEG to assess amplitude, phase stability and<br /><br>cross-frequency coupling of cortical theta (~4 Hz), alpha (~10 Hz) and gamma<br /><br>(>40 Hz) EEG oscillations;<br /><br>5) EQ-5D and WHOQOL to assess quality of life.</p><br>
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