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

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ClinicalTrials.gov Identifier: NCT04811807
Recruitment Status : Not yet recruiting
First Posted : March 23, 2021
Last Update Posted : September 5, 2021
Sponsor:
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
Northern Care Alliance NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Study Description
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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?

Condition or disease Intervention/treatment
Impulsive Behavior Impulse Disorders Gambling, Pathological Eating, Binge Hoarding Disorder Hypersexuality Compulsive Shopping Dopamine Dysregulation Syndrome Caregiver Burnout Parkinson Disease Device: Subthalamic Nucleaus Deep brain stimulation

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Multicentre Observational Study of Impulsive Behaviours Following Deep Brain Stimulation in Parkinson's Disease
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Subthalamic Nucleaus Deep brain stimulation
    In deep brain stimulation (DBS) therapy, a specific anatomical target in the brain is stimulated via surgically fixed electrodes. These electrodes release electrical currents of a specific voltage, wavelength, and frequency. They are connected via subcutaneous wires to a device called an implantable pulse generator (IPG) which is surgically fixed on chest wall, beneath the clavicle. After electrodes and IPG are successfully installed, a clinician will be able to adjust and modulate the stimulation via a remote device connected to the IPG to obtain a maximum potential benefit. Deep brain stimulation has been used in clinics to treat various neurologic diseases including neurodegenerative disorders, mainly movement disorders.
    Other Names:
    • DBS
    • Brain stimulation

Outcome Measures
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Primary Outcome Measures :
  1. change in severity of ICBs and development of new ICBs [ Time Frame: 12 months ]
  2. Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs [ Time Frame: 12 months ]
  3. Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. predictive factors for de novo, recurrence and change in severity of ICD/ICBs [ Time Frame: 12 months ]
  2. change in ICB relate to quality of life in patients and carers [ Time Frame: 12 months ]
  3. change in ICD relates to changes in mood [ Time Frame: 12 months ]
  4. change in ICD relates to change in personality traits [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • nil
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04811807    
Other Study ID Numbers: 285162
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by King's College London:
Deep brain stimulation
Parkinson's disease
Impulse control disorders
Impulse control behaviours
compulsive shopping
hypersexuality
 binge eating
gambling
walkabouts
hobbyism
Hoarding
punding
Additional relevant MeSH terms:
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Parkinson Disease
Disease
Bulimia
Gambling
Impulsive Behavior
Hoarding Disorder
Caregiver Burden
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Stress, Psychological
Behavioral Symptoms
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Obsessive-Compulsive Disorder
Anxiety Disorders
Hyperphagia
Signs and Symptoms, Digestive