Parkinson DiseaseNCT04876404
Somatotopy in Parkinson's Disease
An observational study of Parkinson Disease, run by Pacific Parkinson's Research Centre at 1 site in Canada.
Trial summary
This study aims to assess changes in connections within the brain in Parkinson's disease (PD). We will invite up to 10 people with PD to participate in this study and complete several brain scans using PET (Positron Emission Tomography) and fMRI (functional Magnetic Resonance Imaging) on the Hybrid PET/MRI scanner. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PET/MR Imaging
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2021to 1 Aug 2024
- Phase
- Observational
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with Parkinson's Disease and those without.
Who may be able to join
- Recently diagnosed with early stage Parkinson's Disease (within 5 years of diagnosis) ii. Between the ages of 50 to 85 iii. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
- Healthy Control Individuals
- Healthy male between the ages of 50 and 85 ii. Healthy female between the ages of 50 and 85 iii. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Who cannot join
- Current or past major psychiatric disorders (e.g. depression, anxiety disorders) or other major neurological disease ii. Current or past substance use problems iii. Serious head injury with loss of consciousness for ≥ 5 minutes iv. Fear of enclosed, confined spaces v. Pregnant or breastfeeding vi. Presence of active, recent, or repeated cancer vii. Unstable/undiagnosed medical conditions viii. Certain medications or conditions may impact the ability to participate and these will be discussed on a case by case basis with the study team.
- Weight of more 158 kg x. Inability to remain still during the scans. xi. People for whom MRI is contra-indicated:
- People with a non-MRI safe intrauterine device (IUD);
- Machinist or Metalworkers;
- Cardiac pacemaker, wires or defibrillator;
- Past injury where a piece of metal lodged in your eye or orbit;
Show all 17Show fewer
- Ferromagnetic aneurysm clip;
- Artificial heart valve;
- Brain aneurysm clip;
- Electrical stimulator for nerves or bones or brains;
- Ear or eye implant;
- Implanted drug infusion pump;
- Coil, catheter, or filter in any blood vessel;
- Orthopaedic hardware (artificial joint, plate, screws);
- Other metallic prostheses;
- Shrapnel, bullets, or other metal fragments;
- Surgery (brain or otherwise), tattoos or injection into a join in the last 6 weeks
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC Pacific Parkinson's Research Centre
Vancouver, British Columbia
About this study
Official title: Somatotopy and Striatal Plasticity in Parkinson's Disease
This study aims to assess changes in connections within the brain in Parkinson's disease (PD). We will invite up to 10 people with PD to participate in this study and complete several brain scans using PET (Positron Emission Tomography) and fMRI (functional Magnetic Resonance Imaging) on the Hybrid PET/MRI scanner. We will also invite 10 participants without PD to complete the same scans for comparison. "Somatotopy" refers to how areas of the brain are organized according to the body part they affect. The striatum is the brain region that coordinates complex thinking and movement. Plasticity refers to changes in connections within the brain, which can happen to make up for changes that are related to PD. In this study we will use PET and fMRI imaging together to investigate changes in the striatum in people affected by Parkinson's disease. The hybrid PET/MR scanner allows us to perform simultaneous PET and MRI measurements to investigate this.
Read the detailed description
Purpose
The current investigation aims to study the altered striatal plasticity in early stage PD versus healthy controls to delineate the functional reorganization of dopaminergic projections in PD neurodegeneration. Analysis will be initially restricted to early PD, when compensatory mechanisms are likely compensating for deficits arising from dopamine deficiency. The use of hybrid PET-MRI imaging will allow for the simultaneous assessment of patterns of striatal activation and functional connectivity, as well as dopamine release induced by a variety of cognitive and motor tasks. In the future, depending upon the findings of this study, we will examine the effects of disease progression on segregation of striatal function. Altered plasticity is likely to contribute to clinical progression of disease and to disease and treatment related complications, thus this investigation may help advance the development of more effective PD treatment measures.
This investigation is intended as a pilot study. We currently do not have data on which to base a power analysis for sample size, however based on our previous experience using a double or triple bolus [11C] raclopride techniques, a sample size of 10 individuals per study group is adequate to detect between-group differences in dopamine release using a single bolus technique. Previous investigations we will be referencing in our study have similarly relied on small sample sizes to obtain their data.
We are specifically interested in tracking functional changes within the brain in early PD, as this is when compensatory mechanisms are still compensating for deficits arising from dopamine deficiency. Thus for the purposes of this investigation we would like to focus on early PD, with the potential to follow the PD cohort in a longitudinal fashion in future investigations, to assess progressive loss of segregation over time.
Hypotheses
- In healthy subjects, there will be segregation of striatal activation as measured by cerebral blood flow determined by BOLD fMRI, as well as striatal dopamine release determined using simultaneous [11C]raclopride PET, according to body site (motor activation) and task type (motor vs. cognitive vs. reward)
- In patients with PD, this segregation will be lost in a progressive fashion, in which caudal and dorsal striatal activation and dopamine release are lost first, with these functions shifted to progressively more rostral and ventral regions of the striatum.
Research Design
This is a cross-sectional study on 20 subjects (10 healthy control, 10 PD), involving 2-3 visits per subject to the Pacific Parkinson's Research Centre in UBC, Vancouver, BC. Each study participant will undergo 4 separate scans, 2 scans per day.
- Conditions
- Parkinson Disease
- Being tested
- PET/MR 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.
PET/MR ImagingDiagnostic test
Also called Positron Emission Tomography and Magnetic Resonance Imaging
The hybrid PET/MR scanner can provide information on brain activity during various motor and cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease | Individuals with early stage Parkinson's Disease (diagnosed within the last 5 years) Receives: Diagnostic Test: PET/MR Imaging | |
| Healthy Controls | Healthy control individuals with no neurological or mood disorders. Receives: Diagnostic Test: PET/MR Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Striatal Dopamine Release
[11C]raclopride PET
Measured: Baseline
Striatal Activation
BOLD fMRI
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start25 Jan 2021
- Primary completion27 Nov 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Parkinson's Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, A. Jon Stoessl, Pacific Parkinson's Research Centre
- Investigators
- Jess McKenzie, Study director, Pacific Parkinson's Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876404
- Sponsor's protocol ID
- H19-03166
- Status last verified
- Nov 2023
- First submitted
- 3 May 2021
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatotopy and Striatal Plasticity in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04876404
- Acronym / sponsor ID
- H19-03166
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pacific Parkinson's Research CentreUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 6 May 2021 (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.
This study aims to assess changes in connections within the brain in Parkinson's disease (PD). We will invite up to 10 people with PD to participate in this study and complete several brain scans using PET (Positron Emission Tomography) and fMRI (functional Magnetic Resonance Imaging) on the Hybrid PET/MRI scanner. We will also invite 10 participants without PD to complete the same scans for comparison. "Somatotopy" refers to how areas of the brain are organized according to the body part they affect. The striatum is the brain region that coordinates complex thinking and movement. Plasticity refers to changes in connections within the brain, which can happen to make up for changes that are related to PD. In this study we will use PET and fMRI imaging together to investigate changes in the striatum in people affected by Parkinson's disease. The hybrid PET/MR scanner allows us to perform simultaneous PET and MRI measurements to investigate this.
Detailed description
Purpose
The current investigation aims to study the altered striatal plasticity in early stage PD versus healthy controls to delineate the functional reorganization of dopaminergic projections in PD neurodegeneration. Analysis will be initially restricted to early PD, when compensatory mechanisms are likely compensating for deficits arising from dopamine deficiency. The use of hybrid PET-MRI imaging will allow for the simultaneous assessment of patterns of striatal activation and functional connectivity, as well as dopamine release induced by a variety of cognitive and motor tasks. In the future, depending upon the findings of this study, we will examine the effects of disease progression on segregation of striatal function. Altered plasticity is likely to contribute to clinical progression of disease and to disease and treatment related complications, thus this investigation may help advance the development of more effective PD treatment measures.
This investigation is intended as a pilot study. We currently do not have data on which to base a power analysis for sample size, however based on our previous experience using a double or triple bolus [11C] raclopride techniques, a sample size of 10 individuals per study group is adequate to detect between-group differences in dopamine release using a single bolus technique. Previous investigations we will be referencing in our study have similarly relied on small sample sizes to obtain their data.
We are specifically interested in tracking functional changes within the brain in early PD, as this is when compensatory mechanisms are still compensating for deficits arising from dopamine deficiency. Thus for the purposes of this investigation we would like to focus on early PD, with the potential to follow the PD cohort in a longitudinal fashion in future investigations, to assess progressive loss of segregation over time.
Hypotheses
- In healthy subjects, there will be segregation of striatal activation as measured by cerebral blood flow determined by BOLD fMRI, as well as striatal dopamine release determined using simultaneous [11C]raclopride PET, according to body site (motor activation) and task type (motor vs. cognitive vs. reward)
- In patients with PD, this segregation will be lost in a progressive fashion, in which caudal and dorsal striatal activation and dopamine release are lost first, with these functions shifted to progressively more rostral and ventral regions of the striatum.
Research Design
This is a cross-sectional study on 20 subjects (10 healthy control, 10 PD), involving 2-3 visits per subject to the Pacific Parkinson's Research Centre in UBC, Vancouver, BC. Each study participant will undergo 4 separate scans, 2 scans per day.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | Diagnostic Test: PET/MR ImagingIndividuals with early stage Parkinson's Disease (diagnosed within the last 5 years) |
| Healthy Controls | – | Diagnostic Test: PET/MR ImagingHealthy control individuals with no neurological or mood disorders. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with Parkinson's Disease and those without.
Key inclusion criteria (3 listed)
- Recently diagnosed with early stage Parkinson's Disease (within 5 years of diagnosis) ii. Between the ages of 50 to 85 iii. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
- Healthy Control Individuals
- Healthy male between the ages of 50 and 85 ii. Healthy female between the ages of 50 and 85 iii. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Key exclusion criteria (17 listed)
- Current or past major psychiatric disorders (e.g. depression, anxiety disorders) or other major neurological disease ii. Current or past substance use problems iii. Serious head injury with loss of consciousness for ≥ 5 minutes iv. Fear of enclosed, confined spaces v. Pregnant or breastfeeding vi. Presence of active, recent, or repeated cancer vii. Unstable/undiagnosed medical conditions viii. Certain medications or conditions may impact the ability to participate and these will be discussed on a case by case basis with the study team.
- Weight of more 158 kg x. Inability to remain still during the scans. xi. People for whom MRI is contra-indicated:
- People with a non-MRI safe intrauterine device (IUD);
- Machinist or Metalworkers;
- Cardiac pacemaker, wires or defibrillator;
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 |
|---|---|---|
| PET/MR ImagingAlso: Positron Emission Tomography and Magnetic Resonance ImagingThe hybrid PET/MR scanner can provide information on brain activity during various motor and cognitive tasks. | Diagnostic test | Healthy Controls, Parkinson's Disease |
Primary outcome
Striatal Dopamine Release
Time frame: Baseline
[11C]raclopride PET
Striatal Activation
Time frame: Baseline
BOLD fMRI
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 26 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Jess McKenzie study director
Pacific Parkinson's Research Centre
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 Disease, run by Pacific Parkinson's Research Centre at 1 site in Canada.
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 3 inclusion and 17 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 26 Oct 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 Canada. 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?
Striatal Dopamine Release (time frame: Baseline). The study lists 2 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 26 Oct 2024.