Objective Assessment of Behavioural Disorders in PD

NCT ID: NCT04611581

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-12-31

Brief Summary

The aim of this project is to measure behavioural disorders in Parkinson's disease (PD) patients in a more objective way, in order to facilitate the detection of those symptoms and improve the treatment of non-motor symptoms in Parkinson's disease.

Detailed Description

Apathy and impulse control disorders (ICDs) are frequent non-motor symptoms of PD and negatively affect the quality of life of patients. Although healthcare professionals have begun to understand the extent of the problem faced by those suffering apathy or ICDs, accurate diagnosis is still difficult, as behavioural symptoms are often multidimensional, develop gradually over the course of months and clinical staff have to rely on the self-report of the patient or the report of a family member to assess them. To overcome this issue, the investigators aim to use information and communication technologies to measure apathy and hyperdopaminergic behaviours in PD patients with STN-DBS in an objective way, with the ultimate goal of improving the management of PD patients with STN-DBS.

To do so, the investigators will use three computer-based tasks that measure effort-based decision making and emotion processing in PD patients, and assess motor, cognitive and neuropsychiatric symptoms in parallel with scales and tests. In some select patients, motor symptoms and activity patterns will be monitored with an in-home sensor system before and after deep brain stimulation STN-DBS, and the above mentioned procedures will be repeated 4 months after STN-DBS.

Conditions

Parkinson's Disease; Non-motor Symptoms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PD patients with apathy

PD patients with apathy according to the diagnostic criteria by Robert et al. 2018

No interventions assigned to this group

PD patients with impulse control disorder

PD patients with a) at least one item \>2 or b) at least two items \>1 on the hyperdopaminergic subscale of the Ardouin Scale of Behaviour in Parkinson's Disease

No interventions assigned to this group

PD patients without any relevant neuropsychiatric symptoms

PD patients with a score \<2 on each item of the Ardouin Scale of Behaviour in Parkinson's Disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosed with Parkinson's disease.
• (Planned) STN-DBS.
• Able to understand instructions and provide informed consent.
• Native speaking or proficient French or German
• Montreal Cognitive Assessment (MoCA) with score ≥ 22
• Ability to manipulate handheld dynamometers

Exclusion Criteria

• Disease affecting the brain other than Parkinson's disease
• Suffering from or diagnosed with ongoing psychiatric illnesses
• Severe somatic illnesses leading to reduced life expectancy
• Severe physical disability leading to impairment in basic functional activities
• Participation in a pharmacological study
• Inability to provide informed consent (legal guardianship)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Krack, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Insel Gruppe AG University Hospital of Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2020-01777

Identifier Type: -

Identifier Source: org_study_id