NCT04876404

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 26, 2024

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

May 3, 2021

Last Update Submit

October 23, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Striatal Dopamine Release

    \[11C\]raclopride PET

    Baseline

  • Striatal Activation

    BOLD fMRI

    Baseline

Study Arms (2)

Parkinson's Disease

Individuals with early stage Parkinson's Disease (diagnosed within the last 5 years)

Diagnostic Test: PET/MR Imaging

Healthy Controls

Healthy control individuals with no neurological or mood disorders.

Diagnostic Test: PET/MR Imaging

Interventions

PET/MR ImagingDIAGNOSTIC_TEST

The hybrid PET/MR scanner can provide information on brain activity during various motor and cognitive tasks.

Also known as: Positron Emission Tomography and Magnetic Resonance Imaging
Healthy ControlsParkinson's Disease

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with Parkinson's Disease and those without.

You may qualify if:

  • i. 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
  • i. 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

You may not qualify if:

  • i. 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.
  • ix. 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;
  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Pacific Parkinson's Research Centre

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Positron-Emission TomographyMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Jess McKenzie

    Pacific Parkinson's Research Centre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Head of Neurology

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 6, 2021

Study Start

January 25, 2021

Primary Completion

November 27, 2023

Study Completion

August 1, 2024

Last Updated

October 26, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations