Somatotopy in Parkinson's Disease

Sponsor
Pacific Parkinson's Research Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04876404
Collaborator
University of British Columbia (Other)
20
1
15.1
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PET/MR Imaging

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

  1. 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)

  2. 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

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Somatotopy and Striatal Plasticity in Parkinson's Disease
Actual Study Start Date :
Jan 25, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Parkinson's Disease

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

Diagnostic Test: PET/MR Imaging
The hybrid PET/MR scanner can provide information on brain activity during various motor and cognitive tasks.
Other Names:
  • Positron Emission Tomography and Magnetic Resonance Imaging
  • Healthy Controls

    Healthy control individuals with no neurological or mood disorders.

    Diagnostic Test: PET/MR Imaging
    The hybrid PET/MR scanner can provide information on brain activity during various motor and cognitive tasks.
    Other Names:
  • Positron Emission Tomography and Magnetic Resonance Imaging
  • Outcome Measures

    Primary Outcome Measures

    1. Striatal Dopamine Release [Baseline]

      [11C]raclopride PET

    2. Striatal Activation [Baseline]

      BOLD fMRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Parkinson's Disease Individuals

    Inclusion Criteria:
    1. Recently diagnosed with early stage Parkinson's Disease (within 5 years of diagnosis)
    2. 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

    Inclusion Criteria:
    1. 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
    Exclusion Criteria (All Individuals):
    1. 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.

    2. 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;

    • Shrapnel, bullets, or other metal fragments;

    • Surgery (brain or otherwise), tattoos or injection into a join in the last 6 weeks

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monica Yenko Vancouver British Columbia Canada

    Sponsors and Collaborators

    • Pacific Parkinson's Research Centre
    • University of British Columbia

    Investigators

    • Study Director: Jess McKenzie, Pacific Parkinson's Research Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    A. Jon Stoessl, Professor & Head of Neurology, Pacific Parkinson's Research Centre
    ClinicalTrials.gov Identifier:
    NCT04876404
    Other Study ID Numbers:
    • H19-03166
    First Posted:
    May 6, 2021
    Last Update Posted:
    May 6, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2021