Objective Assessment of Behavioural Disorders in PD

Parkinson's Disease Clinical Trial

— TECHNO-PARK  

Official title:

Objective Assessment of Behavioural Disorders in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611581
• Other study ID #: 2020-01777
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: Deborah Amstutz, MSc Psy
• Phone: +41 31 664 05 67
• Email: deborah.amstutz[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Non-motor Symptoms
• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Switzerland	Insel Gruppe AG University Hospital of Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern, University of Oxford

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Performance in a reward task	Pupil diameter (in mm)	Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
Primary	Performance in a reward task	Pupil diameter (in mm)	Visit 3 (only for DBS patients; 11-13 months after DBS-surgery)
Primary	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)
Primary	Performance in an emotion processing task	Pupil diameter (in mm)	Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
Primary	Performance in an emotion processing task	Pupil diameter (in mm)	Visit 3 (only for DBS patients; 11-13 months after DBS-surgery)
Primary	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