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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04811807
Acronym
CRIPS
Enrollment
50
Registered
2021-03-23
Start date
2021-10-31
Completion date
2024-11-30
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burnout, Compulsive Shopping, Dopamine Dysregulation Syndrome, Eating, Binge, Gambling, Pathological, Hoarding Disorder, Hypersexuality, Impulse Disorders, Impulsive Behavior, 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

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.

Interventions

DEVICESubthalamic 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* nil

Design outcomes

Primary

MeasureTime frame
change in severity of ICBs and development of new ICBs12 months
Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs12 months
Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs12 months

Secondary

MeasureTime frame
predictive factors for de novo, recurrence and change in severity of ICD/ICBs12 months
change in ICD relates to change in personality traits12 months
change in ICB relate to quality of life in patients and carers12 months
change in ICD relates to changes in mood12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026