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Active, Not Recruiting

NCT Number: NCT04611581

Objective Assessment of Behavioural Disorders in PD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disruptive, Impulse Control, and Conduct Disorders Lethargy Mental Disorders Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Non-motor Symptoms Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Insel Gruppe AG University Hospital of Bern

Bern, CH-3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Performance in an effort-based decision making task (Apple Tree Paradigm)

    Time frame: Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery)

    Decision (yes/no)

  2. Performance in an effort-based decision making task (Apple Tree Paradigm)

    Time frame: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)

    Decision (yes/no)

  3. Performance in an emotion processing task

    Time frame: Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery)

    Pupil diameter (in mm)

  4. Performance in an emotion processing task

    Time frame: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)

    Pupil diameter (in mm)

  5. Change in overall activity from Baseline to 4 months after DBS-surgery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern
  • University of Oxford

Registry information

Official study title

Objective Assessment of Behavioural Disorders in Parkinson's Disease

Acronym: TECHNO-PARK

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2020
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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