Clinical Response of Impulsivity After Brain Stimulation in Parkinson's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Caregiver Burnout
- Compulsive Shopping
- Dopamine Dysregulation Syndrome
- Eating, Binge
- Gambling, Pathological
- Hoarding Disorder
- Hypersexuality
- Impulse Disorders
- Impulsive Behavior
- Parkinson Disease
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
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 centr...
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.
Tracking Information
- NCT #
- NCT04811807
- Collaborators
- South London and Maudsley NHS Foundation Trust
- NHS Greater Glasgow and Clyde
- King's College Hospital NHS Trust
- Walton Centre NHS Foundation Trust
- Newcastle-upon-Tyne Hospitals NHS Trust
- Oxford University Hospitals NHS Trust
- Barking, Havering and Redbridge University Hospitals NHS Trust
- Salford Royal NHS Foundation Trust
- Investigators
- Not Provided