Parkinson's DiseaseNCT02387346
The Cerebellum as a Potential Treatment Site for PD Motor Symptoms
A study testing Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation in people with Parkinson's Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with idiopathic Parkinson's disease
- ability to walk 10 metres unassisted
- ability to stand for 5 minutes unassisted
- understand verbal instructions in English
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Shannon Lefaivre, BSc contact
Canada1 site, 1 recruiting
- Recruiting
Sun Life Financial Movement Disorders Research & Rehabilitation Centre
Waterloo, Ontario, N2L3C5
Shannon Lefaivre, BSc, lefa3540@mylaurier.ca
About this study
Official title: The Contribution of the Cerebello-thalamo-cortical Circuit to the Pathology of Non-dopaminergic Responsive Parkinson's Disease Symptoms
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
- Being tested
- Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation, Magstim Rapid 2 Sham Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim Rapid 2 Repetitive Transcranial Magnetic StimulationDevice
Magstim Rapid 2 Sham StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation | Experimental | 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. Receives: Device: Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation |
| Sham Stimulation | Sham comparator | 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. Receives: Device: Magstim Rapid 2 Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post stimulation, effects up to one hour
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
Measured: Immediately post stimulation, effects up to one hour
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.
Measured: Immediately post stimulation, effects up to one hour
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)
Measured: Immediately post stimulation, effects up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quincy J Almeida, PhD, Study director, SunLife Financial Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387346
- Sponsor's protocol ID
- 4247
- Status last verified
- Apr 2015
- First submitted
- 3 Mar 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of the Cerebello-thalamo-cortical Circuit to the Pathology of Non-dopaminergic Responsive Parkinson's Disease Symptoms
- ClinicalTrials.gov ID
- NCT02387346
- Acronym / sponsor ID
- 4247
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation CentreUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation | Experimental | Device: Magstim Rapid 2 Repetitive Transcranial Magnetic StimulationParticipants 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 Stimulation | Sham comparator | Device: Magstim Rapid 2 Sham StimulationParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with idiopathic Parkinson's disease
- ability to walk 10 metres unassisted
- ability to stand for 5 minutes unassisted
- understand verbal instructions in English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation | Device | Real Stimulation |
| Magstim Rapid 2 Sham Stimulation | Device | Sham Stimulation |
Primary outcome
Gait (GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Lefaivre, BSc contact
Quincy J Almeida, PhD study director
SunLife Financial Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation in people with Parkinson's Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon Lefaivre, BSc (lefa3540@mylaurier.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.