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The Effect of rPMS on Motor Skill Performance in Persons With a Stroke.

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Peripheral Magnetic Stimulation (rPMS)
Sham Priming
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rPMS, motor skill performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Diagnosed mono-hemispheric stroke More than 3 months since stroke onset. Participants must demonstrate adequate cognitive abilities to be able to follow the protocol (21>MMSE). Exclusion Criteria: Individuals with lesions affecting the brainstem or cerebellum. Other musculoskeletal or neurological impairments such as (Alzheimer, Parkinson, etc.). Complete paralysis that would limit the participant's' ability to perform motor skill tasks.

Sites / Locations

  • Brain Plasticity labRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Sensory-based priming

Sham Priming

Arm Description

Participants will receive rPMS at 10% above motor threshold with the coil placed on the Tibialis Anterior muscle belly. rPMS parameters will be: 40 trains, intermittently (3) seconds on, (19) seconds off, with an intensity ~10% above motor threshold.

Participants will receive sham rPMS at a very low intensity with the coil placed on the dorsal part of the foot. rPMS parameters will be: 40 trains, intermittently (3) seconds on, (19) seconds off, with an intensity at 5% of maximum stimulator output.

Outcomes

Primary Outcome Measures

Motor skill performance
The investigators will assess motor skill performance by asking the participants to track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Each trial lasts for 60 seconds. Participants will be asked to perform 10 familiarization trials, this only to make participants familiar with the task. After the familiarization, participants will perform 5 trials at baseline.
Motor skill performance
The investigators will assess motor skill performance by asking the participants to track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Each trial lasts for 60 seconds. Participants will be asked to perform 5 trials immediately after the stimulation
Motor skill performance
The investigators will assess motor skill performance by asking the participants to track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Each trial lasts for 60 seconds. Participants will be asked to perform 5 trials at 30 minutes after the stimulation
Motor skill performance
The investigators will assess motor skill performance by asking the participants to track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Each trial lasts for 60 seconds. Participants will be asked to perform 5 trials at 60 minutes after the stimulation

Secondary Outcome Measures

Full Information

First Posted
April 10, 2023
Last Updated
June 15, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05833490
Brief Title
The Effect of rPMS on Motor Skill Performance in Persons With a Stroke.
Official Title
The Effect of Peripheral Sensory Priming Using Repetitive Peripheral Magnetic Stimulation (rPMS) on Motor Skill Performance in Persons With a Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the past two decades, even as stroke cases increase around the world, advances in motor rehabilitation have been limited. Clinical trials of stroke rehabilitation have examined the therapeutic utility of several neuromodulatory devices to improve efficacy of motor training. However, there is limited knowledge on the effects of sensory-based priming techniques using repetitive peripheral magnetic stimulation (rPMS) post stroke. This project focuses on understanding the effect of rPMS on motor skill performance in persons with stroke.
Detailed Description
The central hypothesis of this study is that rPMS is a suitable priming technique for enhancing motor skill performance in individuals with stroke. The investigators plan to test our hypothesis by pursuing the following specific aim: To determine whether rPMS can facilitate lower limb's motor skill performance more than sham rPMS in individuals with stroke. Hypothesis: The effect of stimulation on lower limb's motor skill performance will be measured using a visuomotor tracking task at different time points: baseline, immediately after, at 30 minutes, and 60 minutes after stimulation. Individuals with stroke during the rPMS condition will demonstrate greater motor skill performance following rPMS and will be able to sustain the enhanced performance at 30 and 60 minutes after the stimulation, compared to sham condition. This study will improve our understanding of the effects of rPMS, thus encouraging the use of a single session of rPMS as a priming tool to enhance motor skill performance. The proposal is important as it is the first to study the time course effects of rPMS on lower limb's motor skill performance in stroke populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
rPMS, motor skill performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Masking Description
participants will be blind to the experimental condition.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sensory-based priming
Arm Type
Experimental
Arm Description
Participants will receive rPMS at 10% above motor threshold with the coil placed on the Tibialis Anterior muscle belly. rPMS parameters will be: 40 trains, intermittently (3) seconds on, (19) seconds off, with an intensity ~10% above motor threshold.
Arm Title
Sham Priming
Arm Type
Sham Comparator
Arm Description
Participants will receive sham rPMS at a very low intensity with the coil placed on the dorsal part of the foot. rPMS parameters will be: 40 trains, intermittently (3) seconds on, (19) seconds off, with an intensity at 5% of maximum stimulator output.
Intervention Type
Other
Intervention Name(s)
Repetitive Peripheral Magnetic Stimulation (rPMS)
Intervention Description
Repetitive Peripheral Magnetic Stimulation (rPMS) is an external device that delivers repetitive pulsed magnetic fields of sufficient magnitude, will be applied on the tibialis anterior muscle belly at ~ 10% of motor threshold, in order to induce neural action potentials in the lower extremities.
Intervention Type
Other
Intervention Name(s)
Sham Priming
Intervention Description
Sham Priming using the Repetitive Peripheral Magnetic Stimulation (rPMS), it will be applied on the dorsal part of the foot with a minimal intensity at 5% of maximum stimulator output, that is of insufficient magnitude to induce changes in the muscle or nerves of lower extremities.
Primary Outcome Measure Information:
Title
Motor skill performance
Description
The investigators will assess motor skill performance by asking the participants to track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Each trial lasts for 60 seconds. Participants will be asked to perform 10 familiarization trials, this only to make participants familiar with the task. After the familiarization, participants will perform 5 trials at baseline.
Time Frame
at baseline
Title
Motor skill performance
Description
The investigators will assess motor skill performance by asking the participants to track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Each trial lasts for 60 seconds. Participants will be asked to perform 5 trials immediately after the stimulation
Time Frame
0 minutes after the stimulation
Title
Motor skill performance
Description
The investigators will assess motor skill performance by asking the participants to track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Each trial lasts for 60 seconds. Participants will be asked to perform 5 trials at 30 minutes after the stimulation
Time Frame
30 minutes after the stimulation
Title
Motor skill performance
Description
The investigators will assess motor skill performance by asking the participants to track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Each trial lasts for 60 seconds. Participants will be asked to perform 5 trials at 60 minutes after the stimulation
Time Frame
60 minutes after the stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed mono-hemispheric stroke More than 3 months since stroke onset. Participants must demonstrate adequate cognitive abilities to be able to follow the protocol (21>MMSE). Exclusion Criteria: Individuals with lesions affecting the brainstem or cerebellum. Other musculoskeletal or neurological impairments such as (Alzheimer, Parkinson, etc.). Complete paralysis that would limit the participant's' ability to perform motor skill tasks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab E Aljuhni, Msc
Phone
312-996-9056
Email
raljuh2@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sangeetha Madhavan, PhD
Phone
312-995-2517
Email
smadhava@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Plasticity lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab Aljuhni, MSc
Phone
312-996-9056
Email
raljuh2@uic.edu
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan, PhD
Phone
312-995-2517
Email
smadhava@uic.edu
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of rPMS on Motor Skill Performance in Persons With a Stroke.

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