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

I

Insel Gruppe AG, University Hospital Bern

Status

Active, not recruiting

Conditions

Non-motor Symptoms
Parkinson's Disease

Study type

Observational

Funder types

Other

Identifiers

NCT04611581
2020-01777

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

45 participants in 3 patient groups

PD patients with apathy
Description:
PD patients with apathy according to the diagnostic criteria by Robert et al. 2018
PD patients with impulse control disorder
Description:
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
Description:
PD patients with a score \<2 on each item of the Ardouin Scale of Behaviour in Parkinson's Disease

Trial contacts and locations

1

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Central trial contact

Paul Krack, MD; Deborah Amstutz, MSc Psy

Data sourced from clinicaltrials.gov

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