StrokeNCT05833490
The Effect of rPMS on Motor Skill Performance in Persons With a Stroke.
A study testing Repetitive Peripheral Magnetic Stimulation (rPMS) in people with Stroke, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Repetitive Peripheral Magnetic Stimulation (rPMS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peripheral Sensory Priming Using Repetitive Peripheral Magnetic Stimulation (rPMS) on Motor Skill Performance in Persons With a Stroke.
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.
Read the 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
- Being tested
- Repetitive Peripheral Magnetic Stimulation (rPMS), Sham Priming
- Keywords
- rPMS, motor skill performance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham PrimingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 60 minutes after the stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start24 Apr 2023
- Primary completion17 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangeetha Madhavan, University of Illinois Chicago
- Investigators
- Sangeetha Madhavan, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833490
- Sponsor's protocol ID
- 2022-0600
- Status last verified
- May 2024
- First submitted
- 10 Apr 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peripheral Sensory Priming Using Repetitive Peripheral Magnetic Stimulation (rPMS) on Motor Skill Performance in Persons With a Stroke.
- ClinicalTrials.gov ID
- NCT05833490
- Acronym / sponsor ID
- 2022-0600
- Conditions
- Stroke
- Keywords
- rPMS, motor skill performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory-based priming | Experimental | Other: Repetitive Peripheral Magnetic Stimulation (rPMS)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. |
| Sham Priming | Sham comparator | Other: Sham PrimingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Sensory-based priming |
| Sham PrimingSham 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. | Other | Sham Priming |
Primary outcome
Motor skill performance
Time frame: 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.
Motor skill performance
Time frame: 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
Motor skill performance
Time frame: 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
Motor skill performance
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeetha Madhavan, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Peripheral Magnetic Stimulation (rPMS) in people with Stroke, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor skill performance (time frame: at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.