Parkinson Disease Clinical Trial
— CRIPSOfficial title:
Multicentre Observational Study of Impulsive Behaviours Following Deep Brain Stimulation in Parkinson's Disease
NCT number | NCT04811807 |
Other study ID # | 285162 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 2021 |
Est. completion date | November 2024 |
Verified date | March 2021 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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?
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | November 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Selected for DBS to treat motor symptoms of Parkinson's disease - English language fluency Exclusion Criteria: - nil |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
King's College London | Barking, Havering and Redbridge University Hospitals NHS Trust, King's College Hospital NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, NHS Greater Glasgow and Clyde, Oxford University Hospitals NHS Trust, Salford Royal NHS Foundation Trust, South London and Maudsley NHS Foundation Trust, Walton Centre NHS Foundation Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in severity of ICBs and development of new ICBs | 12 months | ||
Primary | Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs | 12 months | ||
Primary | Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs | 12 months | ||
Secondary | predictive factors for de novo, recurrence and change in severity of ICD/ICBs | 12 months | ||
Secondary | change in ICB relate to quality of life in patients and carers | 12 months | ||
Secondary | change in ICD relates to changes in mood | 12 months | ||
Secondary | change in ICD relates to change in personality traits | 12 months |
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