The Cerebellum as a Potential Treatment Site for PD Motor Symptoms
The Contribution of the Cerebello-thalamo-cortical Circuit to the Pathology of Non-dopaminergic Responsive Parkinson's Disease Symptoms
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedApril 9, 2015
April 1, 2015
4 months
March 3, 2015
April 8, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Immediately post stimulation, effects up to one hour
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
Immediately post stimulation, effects up to one hour
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.
Immediately post stimulation, effects up to one hour
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)
Immediately post stimulation, effects up to one hour
Study Arms (2)
Real Stimulation
EXPERIMENTALParticipants 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.
Sham Stimulation
SHAM COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- diagnosed with idiopathic Parkinson's disease
- ability to walk 10 metres unassisted
- ability to stand for 5 minutes unassisted
- understand verbal instructions in English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Life Financial Movement Disorders Research & Rehabilitation Centre
Waterloo, Ontario, N2L3C5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Quincy J Almeida, PhD
SunLife Financial Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 13, 2015
Study Start
April 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
April 9, 2015
Record last verified: 2015-04