Objective Assessment of Behavioural Disorders in PD (TECHNO-PARK)

Objective Assessment of Behavioural Disorders in Parkinson's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease; Non-motor Symptoms

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 in an objective way, with the ultimate goal of improving the management of PD patients.

To do so, the investigators will use three computer-based tasks that measure effort-based decision making, reward processing 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 (DBS), and the above mentioned procedures will be repeated in a longitudinal design.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Deborah Amstutz, MSc Psy; Phone Number: +41 31 664 05 67; Email: deborah.amstutz@insel.ch
• Study Contact Backup: Name: Paul Krack, MD; Phone Number: +41 31 632 21 68; Email: paul.krack@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, CH-3010
    • Recruiting
    • Insel Gruppe AG University Hospital of Bern
    • Contact: Deborah Amstutz, Mc Psy; Phone Number: +41 31 664 05 67; Email: deborah.amstutz@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with idiopathic Parkinson's disease, treated at the movement disorders clinic in the University Hospital of Bern, Switzerland.

Description

Inclusion Criteria:

• Diagnosed with Parkinson's disease.
• 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
• For sensor part only: planned DBS-surgery

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
PD patients with apathy; PD patients with apathy according to the diagnostic criteria by Robert et al. 2018
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance in an effort-based decision making task (Apple Tree Paradigm)	Decision (yes/no)	Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery)
Performance in an effort-based decision making task (Apple Tree Paradigm)	Decision (yes/no)	Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
Performance in an effort-based decision making task (Apple Tree Paradigm)	Decision (yes/no)	Visit 3 (only for DBS patients; 11-13 months after DBS-surgery)
Performance in a reward task	Pupil diameter (in mm)	Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery)
Performance in a reward task	Pupil diameter (in mm)	Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
Performance in a reward task	Pupil diameter (in mm)	Visit 3 (only for DBS patients; 11-13 months after DBS-surgery)
Performance in an emotion processing task	Pupil diameter (in mm)	Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery)
Performance in an emotion processing task	Pupil diameter (in mm)	Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
Performance in an emotion processing task	Pupil diameter (in mm)	Visit 3 (only for DBS patients; 11-13 months after DBS-surgery)
Change in overall activity from Baseline to 12 months after DBS-surgery	Changes in overall activity patterns related to motivated behaviours (measured in minutes per day) will be deducted from collected from in-home sensor data using signal processing and machine learning algorithms	In-home sensor measurements will be collected from 1-3 months before DBS-surgery until 12 months after DBS-surgery

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Oxford; University of Bern
• Investigators: Principal Investigator: Paul Krack, MD, Insel Gruppe AG University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Deep Brain Stimulation; Apathy; Non-motor symptoms; Impulse Control Disorder; Assessment of non-motor symptoms; Sensor monitoring; Behavioural disorders
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2020-01777

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No