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Trial record 2 of 2 for:    apple | First posted from 11/01/2020 to 11/06/2020

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04611581
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : April 29, 2021
Sponsor:
Collaborators:
University of Bern
University of Oxford
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date October 15, 2020
First Posted Date November 2, 2020
Last Update Posted Date April 29, 2021
Actual Study Start Date April 1, 2021
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2020)
  • 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)
  • 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)
  • Performance in an effort-based decision making task (Apple Tree Paradigm) [ Time Frame: Visit 3 (only for DBS patients; 11-13 months after DBS-surgery) ]
    Decision (yes/no)
  • Performance in a reward task [ Time Frame: Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery) ]
    Pupil diameter (in mm)
  • Performance in a reward task [ Time Frame: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery) ]
    Pupil diameter (in mm)
  • Performance in a reward task [ Time Frame: Visit 3 (only for DBS patients; 11-13 months after DBS-surgery) ]
    Pupil diameter (in mm)
  • 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)
  • Performance in an emotion processing task [ Time Frame: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery) ]
    Pupil diameter (in mm)
  • Performance in an emotion processing task [ Time Frame: Visit 3 (only for DBS patients; 11-13 months after DBS-surgery) ]
    Pupil diameter (in mm)
  • Change in overall activity from Baseline to 12 months after DBS-surgery [ Time Frame: In-home sensor measurements will be collected from 1-3 months before DBS-surgery until 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Objective Assessment of Behavioural Disorders in PD
Official Title Objective Assessment of Behavioural Disorders in Parkinson's Disease
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 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Parkinson's Disease
  • Non-motor Symptoms
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 26, 2020)
45
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Deborah Amstutz, MSc Psy +41 31 664 05 67 deborah.amstutz@insel.ch
Contact: Paul Krack, MD +41 31 632 21 68 paul.krack@insel.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04611581
Other Study ID Numbers 2020-01777
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators
  • University of Bern
  • University of Oxford
Investigators
Principal Investigator: Paul Krack, MD Insel Gruppe AG University Hospital Bern
PRS Account University Hospital Inselspital, Berne
Verification Date April 2021