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

NCT04811807 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-09-05

No results posted yet for this study

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?

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • South London and Maudsley NHS Foundation Trust

    collaborator OTHER
  • NHS Greater Glasgow and Clyde

    collaborator OTHER
  • King's College Hospital NHS Trust

    collaborator OTHER
  • Walton Centre NHS Foundation Trust

    collaborator OTHER
  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER
  • Oxford University Hospitals NHS Trust

    collaborator OTHER
  • Barking, Havering and Redbridge University Hospitals NHS Trust

    collaborator OTHER
  • Northern Care Alliance NHS Foundation Trust

    collaborator OTHER
  • King's College London

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2024-10-31
Completion
2024-11-30
FDA Device
Yes

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04811807 on ClinicalTrials.gov