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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT05833490
Collaborator
(none)
100
1
2
22.2
4.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Repetitive Peripheral Magnetic Stimulation (rPMS)
  • Other: Sham Priming
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Masking Description:
participants will be blind to the experimental condition.
Primary Purpose:
Treatment
Official Title:
The Effect of Peripheral Sensory Priming Using Repetitive Peripheral Magnetic Stimulation (rPMS) on Motor Skill Performance in Persons With a Stroke.
Anticipated Study Start Date :
Apr 24, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sensory-based priming

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.

Other: Repetitive Peripheral Magnetic Stimulation (rPMS)
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.

Sham Comparator: Sham Priming

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.

Other: Sham Priming
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.

Outcome Measures

Primary Outcome Measures

  1. Motor skill performance [at baseline]

    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.

  2. Motor skill performance [0 minutes after the stimulation]

    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

  3. Motor skill performance [30 minutes after the stimulation]

    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

  4. Motor skill performance [60 minutes after the stimulation]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 neurological disorders such as (Alzheimer, Parkinson, etc.).

  • Complete paralysis that would limit the participant's' ability to perform motor skill tasks.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brain Plasticity lab Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago

Investigators

  • Principal Investigator: Sangeetha Madhavan, PhD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sangeetha Madhavan, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT05833490
Other Study ID Numbers:
  • 2022-0600
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Sangeetha Madhavan, Professor, University of Illinois at Chicago
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023