NCT04611581

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

4.7 years

First QC Date

October 15, 2020

Last Update Submit

November 4, 2024

Conditions

Parkinson's DiseaseNon-motor Symptoms

Keywords

Parkinson's DiseaseNon-motor symptomsAssessment of non-motor symptomsSensor monitoringBehavioural disordersDeep Brain StimulationApathyImpulse Control Disorder

Outcome Measures

Primary Outcomes (5)

  • 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 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)

  • Change in overall activity from Baseline to 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

    In-home sensor measurements will be collected from 1-3 months before DBS-surgery and 4 months after DBS-surgery

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insel Gruppe AG University Hospital of Bern

Bern, CH-3010, Switzerland

Location

MeSH Terms

Conditions

Parkinson DiseaseMental DisordersLethargyDisruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Krack, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

November 2, 2020

Study Start

April 1, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 6, 2024

Record last verified: 2024-11

Locations

CH(1)