The Cerebellum as a Potential Treatment Site for PD Motor Symptoms

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Status: Unknown

Conditions: Parkinson's Disease

Treatments: Device: Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation; Device: Magstim Rapid 2 Sham Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02387346

4247

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Real Stimulation

Experimental group

Description:

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.

Treatment:

Device: Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation

Sham Stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Magstim Rapid 2 Sham Stimulation