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The Cerebellum as a Potential Treatment Site for PD Motor Symptoms

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation
Magstim Rapid 2 Sham Stimulation
Sponsored by
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with idiopathic Parkinson's disease
  • ability to walk 10 metres unassisted
  • ability to stand for 5 minutes unassisted
  • understand verbal instructions in English

Exclusion Criteria:

  • presence of brain implants (aneurysm clips, deep brain stimulation electrodes)
  • cochlear implants
  • diagnosed with vascular Parkinson's disease
  • history or increased risk of seizure
  • severe dyskinesia of neck muscles

Sites / Locations

  • Sun Life Financial Movement Disorders Research & Rehabilitation CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real Stimulation

Sham Stimulation

Arm Description

Participants in this group will receive Repetitive Transcranial Magnetic Stimulation, characterized by 900 pulses at 1Hz over the medial cerebellum at 120% resting motor threshold of the right first dorsal interosseous.

Participants will receive Sham Repetitive Transcranial Magnetic Stimulation by having the coil angled at 90 degrees to the scalp; this will allow adequate noise output from the stimulator in the absence on real magnetic stimulation.

Outcomes

Primary Outcome Measures

Gait (GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.)
5 trials of self-paced gait on a GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.
Balance: Postural Stability Testing (quiet stance on a balance force plate)
3 trials lasting 30 seconds each of quiet stance on a balance force plate, where postural deviations from a central reference point on the platform will give an overall measure of postural sway, as well as score in the medial-lateral and anterior-posterior direction
Balance: Sensory Integration Testing (modified clinical test of sensory integration on balance (m-CTSIB)
In accordance with the modified clinical test of sensory integration on balance (m-CTSIB), where four trials lasting 20 seconds each measure balance during various sensory conditions: 1) eyes open, firm platform, 2) eyes closed, firm platform, 3) eyes open, foam platform, 4) eyes closed, foam platform.
Tremor: Kinesia Homeview Tablet (tremor magnitude, frequency and amplitude can be measured with wireless finger accelerometer)
With the use of a wireless finger accelerometer, tremor magnitude, frequency and amplitude can be measured during the upper limb movement tasks (such as rapid alternation and pointing tasks)

Secondary Outcome Measures

Full Information

First Posted
March 3, 2015
Last Updated
April 8, 2015
Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02387346
Brief Title
The Cerebellum as a Potential Treatment Site for PD Motor Symptoms
Official Title
The Contribution of the Cerebello-thalamo-cortical Circuit to the Pathology of Non-dopaminergic Responsive Parkinson's Disease Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The role of the cerebello-thalamo-cortical loop in the generation of tremor, gait impairments and postural instability has been made evident. The current study will use a Magstim Rapid 2 to deliver rTMS with the aim of modulating the activity in the vermal/paravermal region of the cerebellum, and consequently the cerebello-thalamo-cortical pathway. Analysis of the effects of an acute session of stimulation will be made to determine the therapeutic potential of the protocol. Motor symptom improvement will be assessed immediately following stimulation to detect motor symptom improvement up to one hour following stimulation, providing insight into the effectiveness of the protocol to produce benefits which outlast the period of stimulation. Participants will each receive one session of stimulation in the ON state of medication. A pre-assessment will be performed before beginning the session and a post-assessment will be performed immediately following stimulation. There will be two groups, which will both undergo the exact same protocol, however one group will receive real stimulation, and one group will receive sham stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real Stimulation
Arm Type
Experimental
Arm Description
Participants in this group will receive Repetitive Transcranial Magnetic Stimulation, characterized by 900 pulses at 1Hz over the medial cerebellum at 120% resting motor threshold of the right first dorsal interosseous.
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
Participants will receive Sham Repetitive Transcranial Magnetic Stimulation by having the coil angled at 90 degrees to the scalp; this will allow adequate noise output from the stimulator in the absence on real magnetic stimulation.
Intervention Type
Device
Intervention Name(s)
Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
Magstim Rapid 2 Sham Stimulation
Primary Outcome Measure Information:
Title
Gait (GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.)
Description
5 trials of self-paced gait on a GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.
Time Frame
Immediately post stimulation, effects up to one hour
Title
Balance: Postural Stability Testing (quiet stance on a balance force plate)
Description
3 trials lasting 30 seconds each of quiet stance on a balance force plate, where postural deviations from a central reference point on the platform will give an overall measure of postural sway, as well as score in the medial-lateral and anterior-posterior direction
Time Frame
Immediately post stimulation, effects up to one hour
Title
Balance: Sensory Integration Testing (modified clinical test of sensory integration on balance (m-CTSIB)
Description
In accordance with the modified clinical test of sensory integration on balance (m-CTSIB), where four trials lasting 20 seconds each measure balance during various sensory conditions: 1) eyes open, firm platform, 2) eyes closed, firm platform, 3) eyes open, foam platform, 4) eyes closed, foam platform.
Time Frame
Immediately post stimulation, effects up to one hour
Title
Tremor: Kinesia Homeview Tablet (tremor magnitude, frequency and amplitude can be measured with wireless finger accelerometer)
Description
With the use of a wireless finger accelerometer, tremor magnitude, frequency and amplitude can be measured during the upper limb movement tasks (such as rapid alternation and pointing tasks)
Time Frame
Immediately post stimulation, effects up to one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with idiopathic Parkinson's disease ability to walk 10 metres unassisted ability to stand for 5 minutes unassisted understand verbal instructions in English Exclusion Criteria: presence of brain implants (aneurysm clips, deep brain stimulation electrodes) cochlear implants diagnosed with vascular Parkinson's disease history or increased risk of seizure severe dyskinesia of neck muscles
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Lefaivre, BSc
Email
lefa3540@mylaurier.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quincy J Almeida, PhD
Organizational Affiliation
SunLife Financial Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Life Financial Movement Disorders Research & Rehabilitation Centre
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Lefaivre, BSc
Email
lefa3540@mylaurier.ca

12. IPD Sharing Statement

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The Cerebellum as a Potential Treatment Site for PD Motor Symptoms

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