Parkinson's DiseaseNCT02463617
Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study
A study testing magnetic resonance imaging in people with Parkinson's Disease, run by Poitiers University Hospital at 3 sites in France.
Trial summary
This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Nov 2014to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Early onset PD patients and late onset PD patients with siblings available PD patients with or without impulse control disorders Current or past treatment with dopamine agonists or levodopa PD patients without dementia Age < 80 ans
Who cannot join
- Early onset PD patients and late onset PD patients without siblings available PD patients with dementia Age > 80 years
Trial locations and contacts
3 sites in 1 country.
France3 sites
Pascal DERKINDEREN
Nantes
Chu de Poitiers
Poitiers, 86021
Marc VERIN
Rennes
About this study
This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).
- Conditions
- Parkinson's Disease
- Being tested
- magnetic resonance imaging
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingOther
| Study group | Role | What they receive |
|---|---|---|
| PD patients | Other | Not described Receives: Other: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barratt Impulsiveness Scale
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study start21 Nov 2014
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc HOUETO, MD PhD, Principal investigator, Poitiers University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463617
- Sponsor's protocol ID
- IMPULSPARK
- Status last verified
- Sep 2021
- First submitted
- 13 Feb 2015
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT02463617
- Acronym / sponsor ID
- IMPULSPARK
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 21 Nov 2014 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Jun 2015 (estimated)
- 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.
This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients | Other | Other: magnetic resonance imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early onset PD patients and late onset PD patients with siblings available PD patients with or without impulse control disorders Current or past treatment with dopamine agonists or levodopa PD patients without dementia Age < 80 ans
Key exclusion criteria (1 listed)
- Early onset PD patients and late onset PD patients without siblings available PD patients with dementia Age > 80 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imaging | Other | PD patients |
Primary outcome
Barratt Impulsiveness Scale
Time frame: up to three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Jean-Luc HOUETO, MD PhD principal investigator
Poitiers University Hospital, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging in people with Parkinson's Disease, run by Poitiers University Hospital at 3 sites in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Barratt Impulsiveness Scale (time frame: up to three months). 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 5 Oct 2021.