Objective Assessment of Behavioural Disorders in PD

Active, not recruiting

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

• Registration Number: NCT04611581
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-11-02
• Study Start: 2021-04-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance in an effort-based decision making task (Apple Tree Paradigm)	Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)	Decision (yes/no)
Performance in an emotion processing task	Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)	Pupil diameter (in mm)
Change in overall activity from Baseline to 4 months after DBS-surgery	In-home sensor measurements will be collected from 1-3 months before DBS-surgery and 4 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

Trial Locations

Locations (1)

Insel Gruppe AG University Hospital of Bern; 🇨🇭 Bern, Switzerland