The Cerebellum as a Potential Treatment Site for PD Motor Symptoms

NCT ID: NCT02387346

Last Updated: 2015-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Real Stimulation

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.

Group Type EXPERIMENTAL

Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Sham Stimulation

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.

Group Type SHAM_COMPARATOR

Magstim Rapid 2 Sham Stimulation

Intervention Type DEVICE

Interventions

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Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Magstim Rapid 2 Sham Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Life Financial Movement Disorders Research and Rehabilitation Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Quincy J Almeida, PhD

Role: STUDY_DIRECTOR

SunLife Financial Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University

Locations

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Sun Life Financial Movement Disorders Research & Rehabilitation Centre

Waterloo, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Shannon Lefaivre, BSc

Role: CONTACT

Facility Contacts

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Shannon Lefaivre, BSc

Role: primary

Other Identifiers

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4247

Identifier Type: -

Identifier Source: org_study_id

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