The Cerebellum as a Potential Treatment Site for PD Motor Symptoms

April 8, 2015 updated by: Sun Life Financial Movement Disorders Research and Rehabilitation Centre

The Contribution of the Cerebello-thalamo-cortical Circuit to the Pathology of Non-dopaminergic Responsive Parkinson's Disease Symptoms

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L3C5
        • Recruiting
        • Sun Life Financial Movement Disorders Research & Rehabilitation Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real Stimulation
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.
Device: Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation
Sham Comparator: Sham Stimulation
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.
Device: Magstim Rapid 2 Sham Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait (GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.)
Time Frame: Immediately post stimulation, effects up to one hour
5 trials of self-paced gait on a GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.
Immediately post stimulation, effects up to one hour
Balance: Postural Stability Testing (quiet stance on a balance force plate)
Time Frame: Immediately post stimulation, effects up to one hour
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
Immediately post stimulation, effects up to one hour
Balance: Sensory Integration Testing (modified clinical test of sensory integration on balance (m-CTSIB)
Time Frame: Immediately post stimulation, effects up to one hour
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.
Immediately post stimulation, effects up to one hour
Tremor: Kinesia Homeview Tablet (tremor magnitude, frequency and amplitude can be measured with wireless finger accelerometer)
Time Frame: Immediately post stimulation, effects up to one hour
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)
Immediately post stimulation, effects up to one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Investigators

  • Study Director: Quincy J Almeida, PhD, SunLife Financial Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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