Clinical trial NCT04811807: Clinical Response of Impulsivity After Brain Stimulation in Parkinson's Disease
Official title: Multicentre Observational Study of Impulsive Behaviours Following Deep Brain Stimulation in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Impulsive Behavior
Impulse Disorders
Gambling, Pathological
Eating, Binge
Hoarding Disorder
Hypersexuality
Compulsive Shopping
Dopamine Dysregulation Syndrome
Caregiver Burnout
Parkinson Disease
Keywords: Deep brain stimulation
Parkinson's disease
Impulse control disorders
Impulse control behaviours
compulsive shopping
hypersexuality
binge eating
gambling
walkabouts
hobbyism
Hoarding
punding
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
name: NHS Greater Glasgow and Clyde
name: King's College Hospital NHS Trust
name: Walton Centre NHS Foundation Trust
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Oxford University Hospitals NHS Trust
name: Barking, Havering and Redbridge University Hospitals NHS Trust
name: Northern Care Alliance NHS Foundation Trust
First posted: 2021-03-23
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All potential participants will have been selected by their clinicians for DBS to treat their motor symptoms as routine clinical care. They will be approached during their hospital appointment by their clinical care team, who will be the research link to this study, principal investigator

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* nil

Primary outcomes:
measure: change in severity of ICBs and development of new ICBs
timeFrame: 12 months
measure: Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs
timeFrame: 12 months
measure: Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs
timeFrame: 12 months
Secondary outcomes:
measure: predictive factors for de novo, recurrence and change in severity of ICD/ICBs
timeFrame: 12 months
measure: change in ICB relate to quality of life in patients and carers
timeFrame: 12 months
measure: change in ICD relates to changes in mood
timeFrame: 12 months
measure: change in ICD relates to change in personality traits
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: