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

NCT05833490 | Completed DMC

• 1 other identifier: 2022-0600
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

rPMS; motor skill performance

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  0 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 30 minutes after the stimulation

  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

  60 minutes after the stimulation

Study Arms (2)

Sensory-based priming

EXPERIMENTAL

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)

Sham Priming

SHAM COMPARATOR

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

Interventions

Repetitive Peripheral Magnetic Stimulation (rPMS) 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.

Sensory-based priming

Sham Priming 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.

Sham Priming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

Brain Plasticity lab

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sangeetha Madhavan, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will be blind to the experimental condition.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 27, 2023
• Study Start: April 24, 2023
• Primary Completion: October 17, 2023
• Study Completion: December 1, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)