Clinical trial NCT02387346: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Gait (GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.)
timeFrame: Immediately post stimulation, effects up to one hour
measure: Balance: Postural Stability Testing (quiet stance on a balance force plate)
timeFrame: Immediately post stimulation, effects up to one hour
measure: Balance: Sensory Integration Testing (modified clinical test of sensory integration on balance (m-CTSIB)
timeFrame: Immediately post stimulation, effects up to one hour
measure: Tremor: Kinesia Homeview Tablet (tremor magnitude, frequency and amplitude can be measured with wireless finger accelerometer)
timeFrame: Immediately post stimulation, effects up to one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Sun Life Financial Movement Disorders Research & Rehabilitation Centre
state: Ontario
Study officials:
affiliation: SunLife Financial Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University
name: Quincy J Almeida, PhD
role: STUDY_DIRECTOR
References: