StrokePAS - StrokeNCT04515407
Plantarflexor PAS - Stroke
A study testing PAS at Rest, PAS - Active and PAS - Walking in people with Stroke and Hemiparesis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The current project investigates a method called paired associative stimulation (PAS) which is known to influence nervous system function through a process called neuroplasticity. Here the investigators will target function of the ankle plantarflexor muscles because they are critically important to walking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis, Gait Dysfunction
- What is being tested?
- PAS at Rest, PAS - Active and PAS - Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemiparesis resulting from stroke
- single, unilateral, hemispheric stroke (cortical or sub-cortical areas)
- stroke confirmed by neuroimaging (CT or MRI)
- stroke 3 months prior to enrollment
- ability to walk, independently at least 25' on level ground, even if requiring brace or assistive device (cane)
- Veteran Status prioritized
Who cannot join
- lower extremity pain affecting ability to bear weight on legs
- contractures limiting normal range of motion in major lower extremity joints
- other neurological conditions (e.g., Parkinson's Disease, Multiple Sclerosis, ALS), prior traumatic brain injury, severe osteoarthritis or prior pathological fracture
- cardiovascular conditions contraindicative to walking or light exercise
- severe hypertension (i.e., >200/110 at rest that cannot be controlled in resting range of 180/110 mmHg)
- perceptual or cognitive deficits affecting ability to: comprehend, follow three step directions, or provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
Martinez, California, 94553
About this study
Official title: Paired Associative Stimulation to Facilitate Plantarflexor Power Following Stroke
The current project investigates a method called paired associative stimulation (PAS) which is known to influence nervous system function through a process called neuroplasticity. Here the investigators will target function of the ankle plantarflexor muscles because they are critically important to walking. The investigators will study adults who have walking dysfunction resulting from stroke. The study will test three ways of delivering PAS targeted towards brain-muscle connections serving the ankle plantarflexors. The overall goal is to improve functioning of the plantarflexors. The investigators believe that improving plantarflexor function will increase the likelihood of positive effects from gait retraining programs for people post-stroke. Participants will experience all three PAS methods in separate sessions. The investigators will compare differences in the size of these effects to identify the optimal method for delivery of PAS to the ankle plantarflexors. This study is a preliminary step to help us design a better clinical trial of combined PAS and gait retraining.
Read the detailed description
The current project builds on preliminary work in which the investigators have observed a relationship between efficacy of the corticospinal tract serving the plantarflexors and walking function, specifically ankle plantarflexor power, in individuals with chronic post-stroke hemiparesis. The investigators have observed robust associations between: i) PF corticospinal efficacy, and ii) modulation of corticospinal drive, and PF power, particularly in individuals poststroke. Importantly, clinical and demographic factors including: age, stroke chronicity, and lesion location, neither explain, nor modify, these associations. In combination, these findings lead to the investigators' central premise, that improved efficacy of the corticospinal tract serving the plantarflexors will enable augmentation of ankle PF power and contribute to improved walking function in individuals post-stroke. Here the team will investigate use of paired associative stimulation (PAS) to enhance corticospinal efficacy and to the plantarflexors through targeted neuroplasticity. Specifically the team will investigate three approaches to PAS to determine its efficacy for enhancing: i) neural responses, ii) biomechanical effects (A2), and iii) retention of neural and biomechanical effects.
Objectives. This SPiRE project focuses on methodological variables required to optimize efficacy of PAS on:
- corticospinal efficacy to the plantarflexors, and b) walking function (quantified as A2) in Veterans and adults with poststroke walking dysfunction. By achieving the aims, data generated from this SPiRE will contribute to development of more focused and relevant hypotheses to be tested in future studies supported through competitive Merit Review. However, before motivating a larger study, the investigators first seek to determine the salience and magnitude of effects of PAS. In addition to exploring methodological issues related to PAS, data generated from the proposed SPiRE will enable us to determine the appropriate scope of a future project including sample size and dosing. The investigators seek to develop the methodology, determine feasibility, and generate preliminary/exploratory data for sake of determining effect sizes and computing statistical power for future large scale studies in human subjects. The investigators will compare effects of PAS targeting ankle plantarflexion when delivered: at rest, during submaximal activity, and during walking.
- Conditions
- Stroke, Hemiparesis, Gait Dysfunction
- Being tested
- PAS at Rest, PAS - Active, PAS - Walking
- Keywords
- stroke, adult, gait, neuroplasticity
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAS at RestOther
Also called REST
Paired Associative Stimulation will be delivered while the participant is seated and resting.
PAS - ActiveOther
Also called Active
Paired Associative Stimulation will be delivered while the participant is seated and producing submaximal background activity in the plantarflexor muscles.
PAS - WalkingOther
Also called Walking
Paired Associative Stimulation will be delivered while the participant is walking, during the late stance phase of the gait cycle.
| Study group | Role | What they receive |
|---|---|---|
| Order 1 | Other | All participants will receive PAS in three experimental conditions, randomized to the order of condition. Experimental order will be counterbalanced across participants. Order 1 will be: Seated@Rest, Seated@Active, Walking. Receives: Other: PAS at Rest; Other: PAS - Active; Other: PAS - Walking |
| Order 2 | Other | All participants will receive PAS in three experimental conditions, randomized to the order of condition. Experimental order will be counterbalanced across participants. Order 2 will be: Seated@Active, Walking, Seated@Rest. Receives: Other: PAS at Rest; Other: PAS - Active; Other: PAS - Walking |
| Order 3 | Other | All participants will receive PAS in three experimental conditions, randomized to the order of condition. Experimental order will be counterbalanced across participants. Order 3 will be: Walking, Seated@Rest, Seated@Active. Receives: Other: PAS at Rest; Other: PAS - Active; Other: PAS - Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Motor Evoked Potential (MEP) size
The difference in MEP size (area) post-PAS compared to pre-PAS will be quantified as the primary outcome for Aim 1. MEP size is considered an indicator of cortical/neural excitability. An increase in MEP size would suggest that PAS enhanced cortical excitability. MEP size can be expressed in either absolute/raw values or percentage change relative to baseline. A single session of PAS lasts 30-45 minutes.
Measured: immediately post-PAS
change in ankle plantarflexor power (A2)
The difference in A2 post-PAS compared to pre-PAS will be quantified as the primary outcome for Aim 2. A2 quantifies the dynamic force producing capacity and is critical to forward progression during walking. An increase in A2 amplitude, area, or slope would suggest that PAS enhanced cortical excitability/neural connectivity enabling production of greater, more effective plantarflexor power during walking. A2 is expressed relative to the individual subject's body weight. Change in A2 can be expressed in either these normalized units or percentage change relative to baseline. A single session of PAS lasts 30-45 minutes.
Measured: immediately post-PAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Oct 2021
- Primary completion31 Aug 2023
- Study completion30 Sep 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 VA Office of Research and DevelopmentThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive PAS in all three experimental conditions. Each condition will be delivered in a separate session. Sessions will be separated by one week. The order of conditions will be counterbalanced across subjects.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carolynn Patten, PhD, Principal investigator, Martinez Outpatient Clinic and Community Living Center, Martinez, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515407
- Sponsor's protocol ID
- B3609-P
- Other IDs
- 1I21RX003609-01
- Acronym
- PAS - Stroke
- Status last verified
- Feb 2024
- First submitted
- 30 Jul 2020
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Associative Stimulation to Facilitate Plantarflexor Power Following Stroke
- ClinicalTrials.gov ID
- NCT04515407
- Acronym / sponsor ID
- PAS - Stroke / B3609-P
- Conditions
- Stroke, Hemiparesis, Gait Dysfunction
- Keywords
- stroke, adult, gait, neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 17 Aug 2020 (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.
The current project investigates a method called paired associative stimulation (PAS) which is known to influence nervous system function through a process called neuroplasticity. Here the investigators will target function of the ankle plantarflexor muscles because they are critically important to walking. The investigators will study adults who have walking dysfunction resulting from stroke. The study will test three ways of delivering PAS targeted towards brain-muscle connections serving the ankle plantarflexors. The overall goal is to improve functioning of the plantarflexors. The investigators believe that improving plantarflexor function will increase the likelihood of positive effects from gait retraining programs for people post-stroke. Participants will experience all three PAS methods in separate sessions. The investigators will compare differences in the size of these effects to identify the optimal method for delivery of PAS to the ankle plantarflexors. This study is a preliminary step to help us design a better clinical trial of combined PAS and gait retraining.
Detailed description
The current project builds on preliminary work in which the investigators have observed a relationship between efficacy of the corticospinal tract serving the plantarflexors and walking function, specifically ankle plantarflexor power, in individuals with chronic post-stroke hemiparesis. The investigators have observed robust associations between: i) PF corticospinal efficacy, and ii) modulation of corticospinal drive, and PF power, particularly in individuals poststroke. Importantly, clinical and demographic factors including: age, stroke chronicity, and lesion location, neither explain, nor modify, these associations. In combination, these findings lead to the investigators' central premise, that improved efficacy of the corticospinal tract serving the plantarflexors will enable augmentation of ankle PF power and contribute to improved walking function in individuals post-stroke. Here the team will investigate use of paired associative stimulation (PAS) to enhance corticospinal efficacy and to the plantarflexors through targeted neuroplasticity. Specifically the team will investigate three approaches to PAS to determine its efficacy for enhancing: i) neural responses, ii) biomechanical effects (A2), and iii) retention of neural and biomechanical effects.
Objectives. This SPiRE project focuses on methodological variables required to optimize efficacy of PAS on:
- corticospinal efficacy to the plantarflexors, and b) walking function (quantified as A2) in Veterans and adults with poststroke walking dysfunction. By achieving the aims, data generated from this SPiRE will contribute to development of more focused and relevant hypotheses to be tested in future studies supported through competitive Merit Review. However, before motivating a larger study, the investigators first seek to determine the salience and magnitude of effects of PAS. In addition to exploring methodological issues related to PAS, data generated from the proposed SPiRE will enable us to determine the appropriate scope of a future project including sample size and dosing. The investigators seek to develop the methodology, determine feasibility, and generate preliminary/exploratory data for sake of determining effect sizes and computing statistical power for future large scale studies in human subjects. The investigators will compare effects of PAS targeting ankle plantarflexion when delivered: at rest, during submaximal activity, and during walking.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- All participants will receive PAS in all three experimental conditions. Each condition will be delivered in a separate session. Sessions will be separated by one week. The order of conditions will be counterbalanced across subjects.
| Arm | Type | Receives |
|---|---|---|
| Order 1 | Other | Other: PAS at Rest, Other: PAS - Active, Other: PAS - WalkingAll participants will receive PAS in three experimental conditions, randomized to the order of condition. Experimental order will be counterbalanced across participants. Order 1 will be: Seated@Rest, Seated@Active, Walking. |
| Order 2 | Other | Other: PAS at Rest, Other: PAS - Active, Other: PAS - WalkingAll participants will receive PAS in three experimental conditions, randomized to the order of condition. Experimental order will be counterbalanced across participants. Order 2 will be: Seated@Active, Walking, Seated@Rest. |
| Order 3 | Other | Other: PAS at Rest, Other: PAS - Active, Other: PAS - WalkingAll participants will receive PAS in three experimental conditions, randomized to the order of condition. Experimental order will be counterbalanced across participants. Order 3 will be: Walking, Seated@Rest, Seated@Active. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- hemiparesis resulting from stroke
- single, unilateral, hemispheric stroke (cortical or sub-cortical areas)
- stroke confirmed by neuroimaging (CT or MRI)
- stroke 3 months prior to enrollment
- ability to walk, independently at least 25' on level ground, even if requiring brace or assistive device (cane)
Key exclusion criteria (6 listed)
- lower extremity pain affecting ability to bear weight on legs
- contractures limiting normal range of motion in major lower extremity joints
- other neurological conditions (e.g., Parkinson's Disease, Multiple Sclerosis, ALS), prior traumatic brain injury, severe osteoarthritis or prior pathological fracture
- cardiovascular conditions contraindicative to walking or light exercise
- severe hypertension (i.e., >200/110 at rest that cannot be controlled in resting range of 180/110 mmHg)
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 |
|---|---|---|
| PAS at RestAlso: RESTPaired Associative Stimulation will be delivered while the participant is seated and resting. | Other | Order 1, Order 2, Order 3 |
| PAS - ActiveAlso: ActivePaired Associative Stimulation will be delivered while the participant is seated and producing submaximal background activity in the plantarflexor muscles. | Other | Order 1, Order 2, Order 3 |
| PAS - WalkingAlso: WalkingPaired Associative Stimulation will be delivered while the participant is walking, during the late stance phase of the gait cycle. | Other | Order 1, Order 2, Order 3 |
Primary outcome
change in Motor Evoked Potential (MEP) size
Time frame: immediately post-PAS
The difference in MEP size (area) post-PAS compared to pre-PAS will be quantified as the primary outcome for Aim 1. MEP size is considered an indicator of cortical/neural excitability. An increase in MEP size would suggest that PAS enhanced cortical excitability. MEP size can be expressed in either absolute/raw values or percentage change relative to baseline. A single session of PAS lasts 30-45 minutes.
change in ankle plantarflexor power (A2)
Time frame: immediately post-PAS
The difference in A2 post-PAS compared to pre-PAS will be quantified as the primary outcome for Aim 2. A2 quantifies the dynamic force producing capacity and is critical to forward progression during walking. An increase in A2 amplitude, area, or slope would suggest that PAS enhanced cortical excitability/neural connectivity enabling production of greater, more effective plantarflexor power during walking. A2 is expressed relative to the individual subject's body weight. Change in A2 can be expressed in either these normalized units or percentage change relative to baseline. A single session of PAS lasts 30-45 minutes.
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 22 Feb 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.
Carolynn Patten, PhD principal investigator
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAS at Rest, PAS - Active and PAS - Walking in people with Stroke and Hemiparesis, run by VA Office of Research and Development 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 6 inclusion and 6 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 22 Feb 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. 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?
change in Motor Evoked Potential (MEP) size (time frame: immediately post-PAS). The study lists 2 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 22 Feb 2024.