No registrations found.
ID
Source
Brief title
Health condition
Obsessive-compulsive disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. DBS-related changes in amplitude, phase stability and cortocostriatal connectivity of theta (~4 Hz), alpha (~10 Hz) and gamma (>40 Hz) EEG oscillations at electrode contacts and scalp
2. Amplitude, phase stability of theta, alpha and gamma EEG oscillations measured at the electrodes that prelude and accompany the emergence of a compulsive episode during real-life situations and in experimental settings
3. DBS-related clinical changes on clinician-rated questionnaires:
- Yale Brown of Obsessive-Compulsive Scale (Goodman et al., 1989)
- Hamilton Scale for Depression (Hamilton, 1960)
- Hamilton Anxiety Scale (Hamilton, 1959)
- Symptom provocation during IAPS picture task (Bradley
Secondary outcome
1. Characterictics of corticostriatal EEG oscillations that are associated with various cognitive and behavioral paradigms and with sleep.
2. Written diary of OCD symptom experiences and daily activities
3. Demographic information not obtainable for clinical file (e.g. handedness)
Background summary
Rationale: Deep Brain Stimulation (DBS) of the ventral part of the anterior internal capsule (vALIC) is an effective treatment for patients with otherwise treatment-refractory obsessive- compulsive disorder (OCD) (Denys et al 2010). DBS has been utilized in approximately 250 OCD patients worldwide, including 48 patients treated at our department. DBS for OCD shows a response rate of 60% in open and sham-controlled studies (Bais et al 2014). However, the high variability among patients and clinical response patterns has made it difficult to gain systematic insight into the optimal neurosurgical target and stimulation settings. At present, stimulation parameters are based on clinical feedback and previous experience with other patients, which is time-consuming, inefficient and subjective. A quantitatively driven approach to tailor stimulation parameters is urgently needed for more effective and efficient clinical treatment. Preliminary work by our group indicates that neural changes in the frontostriatal network are essential for efficacy of DBS. Recently we acquired prototype bi-directional brain radio devices that not only stimulate but also record activity from the targeted brain structure. We propose to use these unique devices in select patients already implanted with or eligible for DBS electrodes, in order to develop more effective and systematic stimulation DBS parameters. Moreover, these devices will also afford us the possibility to get a greater understanding of the neural pathophysiology of OCD that can be targeted with DBS and other treatment modalities, by allowing us to monitor the brain activity of patients as they experience symptoms in daily life situations.
Objective: Our primary objective is to correlate symptom changes and changes in cognitive functions with frontostriatal responses at different DBS settings, by simultaneously recording local and network EEG activity at the electrodes and scalp. Our secondary objective is to decode ‘’signatures’’ of activity from the electrode before and during OCD attacks by analyzing its activity while patients are experiencing symptoms during a personal tailored experiment and in daily life situations.
Study design and population: Observational cohort study in 12 OCD patients that are in need of battery replacement or are eligible for a first DBS implantation. Instead of a regular neurostimulator, these patients will receive a bi-directional brain radio device. We will use this device to record DBS-related neural changes over a period of 6 months, which will be correlated with relevant clinical changes.
Main study parameters/endpoints: Primary endpoints: 1. DBS-related changes in EEG amplitude, phase stability and corticostriatal connectivity measured at the electrode contacts and scalp. 2. Amplitude and phase-stability of EEG oscillations measured at the DBS contact sides before and during OCD symptoms in real-life situations and in experimental setting. 3. DBS-related clinical changes (including obsessions, compulsions, anxiety and depression) on clinician-rated and self-reported questionnaires and during symptom provocation. Secondary endpoints: Characteristics of corticostriatal EEG oscillations that are associated with various cognitive and behavioral paradigms and with sleep.
Study objective
This is an exploratory pilot study without specific hypotheses.
Study design
Baseline (before surgery)
Visit 1 (before turning on DBS): baseline intracranial recording
Visit 2 (random sequence of different voltages, between 3-5V): intracranial and external EEG recordings at different voltages + resting state EEG
Visit 3 (on / off): Confidence task, Symptom provocation task
Visit 4 (on / off): Confidence task, Symptom provocation task, Social task
Visit 5 (on / off): Stop-signal, Emotion task, Libet task
Visit 6 (on / off): Stop-signal, Emotion task, Libet task, Social task
Visit 7 (on / off): Subliminal perception
Intervention
Deep brain stimulation of the ventral anterior limb of the internal capsule
Inclusion criteria
Subject has provided informed consent.
Primary diagnosis of OCD with DBS-implantation performed in the AMC in the previous years.
Primary diagnosis of OCD and indicated for DBS-implantation in the AMC.
DBS-treatment responsiveness, defined as an improvement in Y-BOCS of >35% at last follow-up compared to pre-surgical baseline.
Exclusion criteria
Subject is unwilling or unable to comply with all study-required follow-up evaluations.
Alcohol or substance abuse during last 6 months.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7486 |
| Other | METC AMC : METC 2015-065 |