Motor Learning After Cerebellar Damage: The Role of the Primary Motor Cortex
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Amanda S Therrien, PhD
- Phone Number: 215-663-6329
- Email: Amanda.Therrien@jefferson.edu
Study Locations
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-
Pennsylvania
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Elkins Park, Pennsylvania, United States, 19027
- Moss Rehabilitation Research Institute
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of cerebellar ataxia from cerebellar degeneration
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
- Meet safety criteria for receipt of transcranial magnetic stimulation
Exclusion Criteria:
- Extrapyramidal signs on neurologic examination
- History of alcohol or illicit drug abuse
- Peripheral sensory loss in the arms
- Cognitive or attention deficits that interfere with testing, the capacity to understand and follow task instructions, or the capacity to provide informed consent
- Orthopedic injury or pain in the arms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: rTMS Intervention
In aim 2 of the study, participants receive a repetitive transcranial magnetic stimulation intervention called theta burst stimulation (TBS) to study its effect on motor learning behavior.
All participants will complete 3 sessions in which they will receive continuous TBS, intermittent TBS, or sham TBS before completing a behavioral motor learning task.
The order of TBS sessions will be counter-balanced across participants.
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Aim 2 of the study includes an intervention where participants receive a repetitive TMS protocol called theta burst stimulation (TBS) to study its effect on motor learning behavior.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Cooperative Ataxia Rating Scale Total Score
Time Frame: Baseline
|
The sore out of 100 that results from assessment using the International Cooperative Ataxia Rating Scale (ICARS).
The rating scale has a minimum score of 0 and a maximum score of 100.
Higher scores indicate more severe impairment.
|
Baseline
|
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International Cooperative Ataxia Rating Scale Limb Coordination Sub-Score
Time Frame: Baseline
|
The score out of 52 that results from assessment using the Limb Kinetic sub-section of the International Cooperative Ataxia Rating Scale (ICARS).
The Limb Kinetic sub-score has a minimum score of 0 and a maximum score of 52.
Higher scores indicate more severe impairment.
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Baseline
|
|
Reinforcement Learning Rate
Time Frame: During the intervention, assessed up to 10 days
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The slope of the time series of reach path lengths (determined from digital 3D kinematic data recorded using a motion capture system) over the first 80 trials of the intervention phase of the reinforcement motor learning task.
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During the intervention, assessed up to 10 days
|
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Total Reinforcement Learning
Time Frame: During the intervention, assessed up to 10 days
|
The difference in mean reach path length (determined from digital 3D kinematic data recorded using a motion capture system) between the baseline phase and the end of the intervention phase of the reinforcement motor learning task.
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During the intervention, assessed up to 10 days
|
|
Slope of the Corticomotor Excitability Recruitment Curve
Time Frame: Baseline
|
The slope of motor evoked potential amplitudes (determined from electromyographic recordings of target muscle activity) between TMS intensities of 120-140% of resting motor threshold.
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Baseline
|
|
Slope of the Short-Interval Intracortical Inhibition (SICI) Recruitment Curve
Time Frame: Baseline
|
SICI will be computed as the difference in average motor evoked potential amplitude (determined from electromyographic recordings of target muscle activity) between a TMS condition where a single conditioning pulse is applied 3 ms before a single test pulse and a TMS condition where only the test pulse is applied.
A range of conditioning pulse TMS intensities will be tested and SICI will be measured for each.
The outcome measure comprises the slope of the SICI values over each conditioning pulse intensity.
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Baseline
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Cortical Silent Period
Time Frame: Baseline
|
Single pulses of TMS will be applied at an intensity of 110% of resting motor threshold while participants tonically activate the target muscle at 20% of their maximum voluntary isometric contraction.
12 repetitions of the protocol will be performed.
The outcome measure comprises the average time, in ms, from the end of the motor evoked potential to the reoccurrence of tonic background electromyographic activity.
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Baseline
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Amanda S Therrien, PhD, Moss Rehabilitation Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AEHN-IRB-2022-881
- P2CHD086844 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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