Clinical Response of Impulsivity After Brain Stimulation in Parkinson's Disease

Study Overview
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Brief Summary
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The objective of this prospective observational cohort study is to answer the following clinically important questions: In patients with a pre-operative history of ICBs, what is the likelihood of improvement or deterioration in ICBs post-operatively? What is the risk of developing post-operative de novo ICBs after Subthalamic Nucleus DBS (STN DBS)? Which factors are important in predicting changes in ICBs after STN DBS? What is the impact of ICBs on carer's quality of life QoL and burden?

Detailed Description
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The study will record outcomes related to ICBs for PD patients who have already been selected for DBS therapy as a routine clinical treatment in participating in DBS operating centre It is routine practice to assess ICBs before DBS decisions are made, but the manner varies across DBS operating centres. The only additional factor to the routine DBS clinical pathway in this study is that the centres involved will perform assessments in a uniform manner to allow data to be combined. A unified set of clinical assessment scales for Impulsive Control Disorders ICDs and ICBs, as well as other relevant neuropsychiatric symptom assessment, will be added to routine pre- and post-operational clinical assessments for participants. The primary endpoint of the study is the change in severity of ICBs. If subjects score above 1 in any of given questions on QUIP-RS, or if subjects had disagreement with carers regarding scores, The Parkinson's Impulse-Control Scale, PICs will be triggered. PICs then will be administered by our trained research fellow (AA), over phone or in the clinic. Other scales to be administered are listed below: Neuropsychiatric Inventory (NPI) General anxiety disorder-7 (GAD-7) Patient Health Questionnaire-9 (PHQ9) Parkinson's disease questionnaire-39 (PDQ-39) EuroQol 5 Dimension (EQ-5D) Clinical Global Impression - Severity scale (CGI-S) at baseline and Clinician's Global Impression - Improvement scale (GGI-I) post-operatively. Zarit Caregiver Burden Scale Work and Social Adjustment Scale UPPS-P Impulsive Behaviour Scale Assessments will be performed at baseline, 3, 6 and 12 months post-operatively. Results will be analysed to ascertain potential predictive measures for ICBS development/change.

Official Title
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Multicentre Observational Study of Impulsive Behaviours Following Deep Brain Stimulation in Parkinson's Disease

Conditions
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Impulsive Behavior, Impulse Disorders, Gambling, Pathological, Eating, Binge, Hoarding Disorder, Hypersexuality, Compulsive Shopping, Dopamine Dysregulation Syndrome, Caregiver Burnout, Parkinson Disease

Intervention / Treatment
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* Device: Subthalamic Nucleaus Deep brain stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Selected for DBS to treat motor symptoms of Parkinson's disease English language fluency Exclusion Criteria: nil
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Subthalamic Nucleaus Deep brain stimulation|In deep brain stimulation (DBS) therapy, a specific anatomical target in the brain is stimulated via surgically fixed electrodes. These electrodes release electrical currents of a specific voltage, wavelength, and frequency. They are connected via subcutaneous wires to a device called an implantable pulse generator (IPG) which is surgically fixed on chest wall, beneath the clavicle. After electrodes and IPG are successfully installed, a clinician will be able to adjust and modulate the stimulation via a remote device connected to the IPG to obtain a maximum potential benefit. Deep brain stimulation has been used in clinics to treat various neurologic diseases including neurodegenerative disorders, mainly movement disorders.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in severity of ICBs and development of new ICBs |  | 12 months | 
| Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs |  | 12 months | 
| Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive factors for de novo, recurrence and change in severity of ICD/ICBs |  | 12 months | 
| change in ICB relate to quality of life in patients and carers |  | 12 months | 
| change in ICD relates to changes in mood |  | 12 months | 
| change in ICD relates to change in personality traits |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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punding, Hoarding, Deep brain stimulation, Parkinson's disease, Impulse control disorders, Impulse control behaviours, compulsive shopping, hypersexuality, binge eating, gambling, walkabouts, hobbyism