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

NCT04811807 | Unknown FDA Device

• 1 other identifier: 285162
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this prospective observational cohort study is to answer the following clinically important questions:

1. 1.In patients with a pre-operative history of ICBs, what is the likelihood of improvement or deterioration in ICBs post-operatively?
2. 2.What is the risk of developing post-operative de novo ICBs after Subthalamic Nucleus DBS (STN DBS)?
3. 3.Which factors are important in predicting changes in ICBs after STN DBS?
4. 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

Keywords

Deep brain stimulation; Parkinson's disease; Impulse control disorders; Impulse control behaviours; compulsive shopping; hypersexuality; binge eating; gambling; walkabouts; hobbyism; Hoarding; punding

Outcome Measures

Primary Outcomes (3)

• change in severity of ICBs and development of new ICBs

  12 months

• Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs

  12 months

• Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs

  12 months

Secondary Outcomes (4)

• predictive factors for de novo, recurrence and change in severity of ICD/ICBs

  12 months

• change in ICB relate to quality of life in patients and carers

  12 months

• change in ICD relates to changes in mood

  12 months

• change in ICD relates to change in personality traits

  12 months

Interventions

Subthalamic Nucleaus Deep brain stimulation DEVICE

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.

Also known as: DBS, Brain stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• nil

Sponsors & Collaborators

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

MeSH Terms

Conditions

Impulsive Behavior; Gambling; Bulimia; Hoarding Disorder; Compulsive Sexual Behavior Disorder; Caregiver Burden; Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders; Hoarding

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Behavior; Risk-Taking; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obsessive-Compulsive Disorder; Anxiety Disorders; Behavior, Addictive; Compulsive Behavior; Sexual and Gender Disorders; Sexual Dysfunctions, Psychological; Stress, Psychological; Behavioral Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share