The Cerebellum as a Potential Treatment Site for PD Motor Symptoms

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02387346
• Other study ID #: 4247
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2015
• Last updated: April 8, 2015
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: April 2015
• Source: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
• Contact: Shannon Lefaivre, BSc
• Email: lefa3540[@]mylaurier.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation

• Magstim Rapid 2 Sham Stimulation

Locations

Country	Name	City	State
Canada	Sun Life Financial Movement Disorders Research & Rehabilitation Centre	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No