The Cerebellum as a Potential Treatment Site for PD Motor Symptoms

Not Applicable

• Conditions: Parkinson's Disease

• Registration Number: NCT02387346
• Lead Sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-13
• Status Verified: 2015-04
• Study Start: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait (GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.)	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.
Balance: Postural Stability Testing (quiet stance on a balance force plate)	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
Balance: Sensory Integration Testing (modified clinical test of sensory integration on balance (m-CTSIB)	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.
Tremor: Kinesia Homeview Tablet (tremor magnitude, frequency and amplitude can be measured with wireless finger accelerometer)	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)

Trial Locations

Locations (1)

Sun Life Financial Movement Disorders Research & Rehabilitation Centre; 🇨🇦 Waterloo, Ontario, Canada