Cyclic deep brain stimulation for obsessive-compulsive disorder

Cyclic deep brain stimulation for obsessive-compulsive disorder - Cyclic DBS for OCD.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55421

Enrollment

Registered

2018-05-25

Start date

2018-10-02

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

obsessive-compulsive disorder

Interventions

Continuous DBS, i.e. the patients regular DBS settings Cyclic DBS, i.e. the regular DBS settings delivered in a cyclic pattern of 0.1 seconds ON and 0.2 seconds OFF.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1) Clinician rated symptom scales: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) 2) Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS) 4) battery power and charging frequency 5) adverse events	—

Secondary

Measure	Time frame
1) Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS) 2) battery power and battery usage 3) adverse events1) subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess cognitive functions 4) resting state scalp EEG to assess amplitude, phase stability and cross-frequency coupling of cortical theta (~4 Hz), alpha (~10 Hz) and gamma (>40 Hz) EEG oscillations; 5) EQ-5D and WHOQOL to assess quality of life.	—

Measure

Time frame

1) Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS) 2) battery power and battery usage 3) adverse events1) subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess cognitive functions 4) resting state scalp EEG to assess amplitude, phase stability and cross-frequency coupling of cortical theta (~4 Hz), alpha (~10 Hz) and gamma (>40 Hz) EEG oscillations; 5) EQ-5D and WHOQOL to assess quality of life.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)