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

NCT ID: NCT05833490

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2023-12-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Repetitive Peripheral Magnetic Stimulation (rPMS)

Intervention Type: OTHER

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 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.

Group Type: SHAM_COMPARATOR

Sham Priming

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Sangeetha Madhavan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sangeetha Madhavan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Brain Plasticity lab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2022-0600

Identifier Type: -

Identifier Source: org_study_id