Parkinson's DiseaseTECHNO-PARKNCT04611581
Objective Assessment of Behavioural Disorders in PD
An observational study of Parkinson's Disease and Non-motor Symptoms, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease, Non-motor Symptoms
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with idiopathic Parkinson's disease, treated at the movement disorders clinic in the University Hospital of Bern, Switzerland.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Insel Gruppe AG University Hospital of Bern
Bern, CH-3010
About this study
Official title: Objective Assessment of Behavioural Disorders in Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson's Disease, Non-motor Symptoms
- Keywords
- Parkinson's Disease, Non-motor symptoms, Assessment of non-motor symptoms, Sensor monitoring, Behavioural disorders, Deep Brain Stimulation, Apathy, Impulse Control Disorder
- Medical subject headings
- Parkinson Disease, Mental Disorders, Lethargy, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in an effort-based decision making task (Apple Tree Paradigm)
Decision (yes/no)
Measured: 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)
Measured: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
Performance in an emotion processing task
Pupil diameter (in mm)
Measured: 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)
Measured: 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
Measured: In-home sensor measurements will be collected from 1-3 months before DBS-surgery and 4 months after DBS-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Apr 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Paul Krack, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611581
- Sponsor's protocol ID
- 2020-01777
- Acronym
- TECHNO-PARK
- Status last verified
- Nov 2024
- First submitted
- 15 Oct 2020
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Behavioural Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04611581
- Acronym / sponsor ID
- TECHNO-PARK / 2020-01777
- Conditions
- Parkinson's Disease, Non-motor Symptoms
- Keywords
- Parkinson's Disease, Non-motor symptoms, Assessment of non-motor symptoms, Sensor monitoring, Behavioural disorders, Deep Brain Stimulation, Apathy, Impulse Control Disorder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, University of Oxford
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with idiopathic Parkinson's disease, treated at the movement disorders clinic in the University Hospital of Bern, Switzerland.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Krack, MD principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Non-motor Symptoms, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.