StrokeNCT03645122
Spinal Plasticity to Enhance Motor Retraining After Stroke
A study testing Paired corticospinal-motoneuronal stimulation (PCMS) in people with Stroke and Cerebrovascular Accident, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The objective of this project is to study the effects of an emerging noninvasive neuromodulation strategy in human stroke survivors with movement-related disability. Muscle weakness after stroke results from the abnormal interaction between cells in the brain that send commands to control movement and cells in the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebrovascular Accident, Hemiparesis
- What is being tested?
- Paired corticospinal-motoneuronal stimulation (PCMS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 75 years old
- Diagnosis of first-ever stroke
- Stroke onset of at least six months prior to the time of participation
Who cannot join
- History of seizure or epilepsy
- Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for subjects undergoing MRI)
- Pregnant or expecting to become pregnant
- Difficulty maintaining alertness and/or remaining still
- Body weight > 300 lbs due to MRI scanner dimensions (for subjects undergoing MRI)
- Cognitive or language impairments that would interfere with the ability to follow simple instructions, as judged by the investigators
- Diagnosis of movement disorder(s) other than stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Plasticity in the Spinal Cord to Enhance Motor Retraining After Stroke
The objective of this project is to study the effects of an emerging noninvasive neuromodulation strategy in human stroke survivors with movement-related disability. Muscle weakness after stroke results from the abnormal interaction between cells in the brain that send commands to control movement and cells in the spinal cord that cause muscles to produce movement. The neuromodulation strategy central to this project has been shown the strengthen the physical connection between both cells, producing a change in movement potential of muscles weakened by stroke.
Read the detailed description
Stroke is a leading cause of serious long-term disability in the United States with 795,000 individuals suffering a new or recurrent stroke each year. In most cases, disability is associated with incomplete motor recovery of the paretic limb. Full recovery is often not achieved, creating a need for neuromodulation strategies that target the physiological mechanisms impaired by stroke to fully harness the adaptive capacity of the nervous system. The neuromodulation protocol that will be tested in these experiments will target connections between the brain and spinal cord with noninvasive stimulation to enhance movement potential of the hand. Individuals who experienced a single stroke at least 6 months ago may be eligible to participate.
- Conditions
- Stroke, Cerebrovascular Accident, Hemiparesis
- Being tested
- Paired corticospinal-motoneuronal stimulation (PCMS), Sham stimulation
- Keywords
- Neuromodulation, Transcranial magnetic stimulation (TMS), Electrical stimulation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paired corticospinal-motoneuronal stimulation (PCMS)Other
Synapses in the spinal cord that transmit voluntary movement commands from the brain to hand muscles will be activated by noninvasive stimulation in a particular sequence and interval that has been shown to strengthen connectivity.
Sham stimulationOther
Synapses in the spinal cord that transmit voluntary movement commands from the brain to hand muscles will not be activated by noninvasive stimulation in a particular sequence and interval that has been shown to strengthen connectivity.
| Study group | Role | What they receive |
|---|---|---|
| PCMS REST | Experimental | PCMS will be triggered while the hand/digits are at rest. Receives: Other: Paired corticospinal-motoneuronal stimulation (PCMS) |
| SHAM | Active comparator | SHAM stimulation will be triggered when a criterion level of force stability by the hand/digits is achieved. Receives: Other: Sham stimulation |
| PCMS ACTIVE | Experimental | PCMS will be triggered when a criterion level of force stability by the hand/digits is achieved. Receives: Other: Paired corticospinal-motoneuronal stimulation (PCMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Control & Learning
A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed.
Measured: Measured under each condition, with approximately 2 months required for completion of all conditions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start4 Feb 2019
- Primary completion29 Sep 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Transcranial magnetic stimulation targeting the region of the brain responsible for voluntary movement control and electrical stimulation to a peripheral nerve innervating hand muscles will be triggered at an interval that elicits action potentials arriving in a set sequence and predetermined delay in the spinal cord.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael A. Urbin, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645122
- Sponsor's protocol ID
- B2837-W
- Other IDs
- 1617296
- Status last verified
- Sep 2024
- First submitted
- 22 Aug 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.
PubMed 22179539
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticity in the Spinal Cord to Enhance Motor Retraining After Stroke
- ClinicalTrials.gov ID
- NCT03645122
- Acronym / sponsor ID
- B2837-W
- Conditions
- Stroke, Cerebrovascular Accident, Hemiparesis
- Keywords
- Neuromodulation, Transcranial magnetic stimulation (TMS), Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to study the effects of an emerging noninvasive neuromodulation strategy in human stroke survivors with movement-related disability. Muscle weakness after stroke results from the abnormal interaction between cells in the brain that send commands to control movement and cells in the spinal cord that cause muscles to produce movement. The neuromodulation strategy central to this project has been shown the strengthen the physical connection between both cells, producing a change in movement potential of muscles weakened by stroke.
Detailed description
Stroke is a leading cause of serious long-term disability in the United States with 795,000 individuals suffering a new or recurrent stroke each year. In most cases, disability is associated with incomplete motor recovery of the paretic limb. Full recovery is often not achieved, creating a need for neuromodulation strategies that target the physiological mechanisms impaired by stroke to fully harness the adaptive capacity of the nervous system. The neuromodulation protocol that will be tested in these experiments will target connections between the brain and spinal cord with noninvasive stimulation to enhance movement potential of the hand. Individuals who experienced a single stroke at least 6 months ago may be eligible to participate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Transcranial magnetic stimulation targeting the region of the brain responsible for voluntary movement control and electrical stimulation to a peripheral nerve innervating hand muscles will be triggered at an interval that elicits action potentials arriving in a set sequence and predetermined delay in the spinal cord.
| Arm | Type | Receives |
|---|---|---|
| PCMS REST | Experimental | Other: Paired corticospinal-motoneuronal stimulation (PCMS)PCMS will be triggered while the hand/digits are at rest. |
| SHAM | Active comparator | Other: Sham stimulationSHAM stimulation will be triggered when a criterion level of force stability by the hand/digits is achieved. |
| PCMS ACTIVE | Experimental | Other: Paired corticospinal-motoneuronal stimulation (PCMS)PCMS will be triggered when a criterion level of force stability by the hand/digits is achieved. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 75 years old
- Diagnosis of first-ever stroke
- Stroke onset of at least six months prior to the time of participation
Key exclusion criteria (7 listed)
- History of seizure or epilepsy
- Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for subjects undergoing MRI)
- Pregnant or expecting to become pregnant
- Difficulty maintaining alertness and/or remaining still
- Body weight > 300 lbs due to MRI scanner dimensions (for subjects undergoing MRI)
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 |
|---|---|---|
| Paired corticospinal-motoneuronal stimulation (PCMS)Synapses in the spinal cord that transmit voluntary movement commands from the brain to hand muscles will be activated by noninvasive stimulation in a particular sequence and interval that has been shown to strengthen connectivity. | Other | PCMS ACTIVE, PCMS REST |
| Sham stimulationSynapses in the spinal cord that transmit voluntary movement commands from the brain to hand muscles will not be activated by noninvasive stimulation in a particular sequence and interval that has been shown to strengthen connectivity. | Other | SHAM |
Primary outcome
Motor Control & Learning
Time frame: Measured under each condition, with approximately 2 months required for completion of all conditions.
A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22179539Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.
- 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.
Michael A. Urbin, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paired corticospinal-motoneuronal stimulation (PCMS) in people with Stroke and Cerebrovascular Accident, 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 3 inclusion and 7 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 19 Sep 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Control & Learning (time frame: Measured under each condition, with approximately 2 months required for completion of all conditions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645122, which also lists 1 linked publication.
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 19 Sep 2024.