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

September 3, 2021 updated by: King's College London

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

King's College Hospital NHS Trust
Northern Care Alliance NHS Foundation Trust
Barking, Havering and Redbridge University Hospitals NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Oxford University Hospitals NHS Trust
NHS Greater Glasgow and Clyde
South London and Maudsley NHS Foundation Trust
Walton Centre NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 285162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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