Recruiting

Observational Study

Sponsor:

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Code:

NCT02387346

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation

Magstim Rapid 2 Sham Stimulation

Study Details

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.

Conditions

Parkinson's Disease

Study ID

NCT02387346

Start date

Apr, 2015

Status verified date

Apr, 2015

Completion date

Aug, 2015

Anticipated

Primary completion date

Aug, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation

Magstim Rapid 2 Sham Stimulation

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Shannon Lefaivre, BSc

lefa3540@mylaurier.ca

Locations

Sun Life Financial Movement Disorders Research & Rehabilitation Centre

Recruiting

Waterloo, Ontario, Canada, N2L3C5

Contacts

Shannon Lefaivre, BSc

lefa3540@mylaurier.ca

More Information

Sponsor

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Last update posted

Apr 9, 2015

Last verified

Apr, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sun Life Financial Movement Disorders Research and Rehabilitation Centre on 2015-04-09.