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

Not yet recruiting

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

• Registration Number: NCT04811807
• Lead Sponsor: King's College London

Brief Summary

The objective of this prospective observational cohort study is to answer the following clinically important questions:

1. In patients with a pre-operative history of ICBs, what is the likelihood of improvement or deterioration in ICBs post-operatively?

2. What is the risk of developing post-operative de novo ICBs after Subthalamic Nucleus DBS (STN DBS)?

3. Which factors are important in predicting changes in ICBs after STN DBS?

4. What is the impact of ICBs on carer's quality of life QoL and burden?

Detailed 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 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:

1. Neuropsychiatric Inventory (NPI)

2. General anxiety disorder-7 (GAD-7)

3. Patient Health Questionnaire-9 (PHQ9)

4. Parkinson's disease questionnaire-39 (PDQ-39)

5. EuroQol 5 Dimension (EQ-5D)

6. Clinical Global Impression - Severity scale (CGI-S) at baseline and Clinician's Global Impression - Improvement scale (GGI-I) post-operatively.

7. Zarit Caregiver Burden Scale

8. Work and Social Adjustment Scale

9. 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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05
• Study Start: 2021-10
• Primary Completion: 2024-10
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Selected for DBS to treat motor symptoms of Parkinson's disease
• English language fluency

Exclusion Criteria

• nil

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 change in personality traits	12 months
change in ICD relates to changes in mood	12 months