StrokeNCT03517657
Bilateral Priming Plus Task Specific Training for Severe Upper Limb Hemiparesis
A study testing Bilateral Motor Priming + Task Specific Training (BMP + TST) in people with Stroke, run by Northwestern University at 2 sites in United States.
Trial summary
The purpose of the study is to determine the best treatment for the arm that has been affected by a stroke. The investigators plan to determine if the arm affected by a stroke will improve with a combination of motor priming and motor training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Bilateral Motor Priming + Task Specific Training (BMP + TST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jan 2018to 30 Mar 2025
- 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
- FMUE TEST score of 23 to 40
- evidence of stroke without involvement of cerebellum at least 6 months prior to enrollment;
- 0-3 wrist flexion/wrist extension on Modified Ashworth Scale
Who cannot join
- orthopedic conditions of less affected or affected wrist
- MMSE of lower than 21
- metal implant or fragments in head or neck area
- history of seizures, epilepsy or convulsions
- previous concussion associated with LOC
- ringing in ears; cochlear implants
Show all 11Show fewer
- history of persistent headaches
- presence of pacemaker or neurostimulator
- pregnant women
- Metastatic cancer
- Other neurological conditions (as in Cerebral Palsy or Parkinson's)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University and Shirley Ryan Ability Lab
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60613
About this study
The purpose of the study is to determine the best treatment for the arm that has been affected by a stroke. The investigators plan to determine if the arm affected by a stroke will improve with a combination of motor priming and motor training. Motor priming provides a warm up for the brain so that the brain and body will better respond to treatment. There are two types of priming in this study. One is called bilateral motor priming which involves using both hands. Bilateral priming requires that the individual make continuous wrist movements in a low-tech gadget called the Exsurgo primer, a piece of equipment in which each hand goes between two plates that are connected together so that the stronger wrist moves the weaker wrist in and out at the same time. The second type of priming includes use of low intensity stimulation for your affected arm. The investigators expect the bilateral priming group will have more improvement. The study team anticipates enrolling approximately 76 individuals with stroke at Northwestern University and Shirley Ryan AbilityLab into this study. Each participant will have 24 visits. Nine visits will be for evaluation and fifteen for therapy. Each visit will be two to three hours depending on the type of visit and tests being done. Participants who are eligible and want to participate in this study will be randomized (selected by chance) to one of the two groups. The possible groups are: 1) bilateral priming plus motor training and 2) electrical stimulation priming and motor training. Participants are not blinded. Evaluation sessions consist of three separate days of testing and will occur at three time points: (1) before treatment starts; (2) after treatment is completed; and (3) 8 weeks later (follow-up evaluation: visits 22-24). There are three motor assessments, the Neuro-QOL (short form), and an evaluation of cortical excitability using TMS. After a stroke, there is often an imbalance of excitability between the affected and less affected parts of the brain. The imbalance will be measured using Transcranial Magnetic Stimulation (TMS), a technique used in neurorehabilitation research. TMS will not be used for treatment. There will also be a grip termination evaluation. This test will determine how long it takes to relax the affected hand after gripping an object.
Read the detailed description
Priming techniques to enhance use dependent plasticity have been examined in stroke rehabilitation research. Priming can upregulate ipsilesional cortex and/or down regulate contralesional cortex to improve effectiveness of subsequent therapy. Most priming techniques are costly and approved only for research. Here, we describe a priming technique that is cost-effective and has the potential to significantly change clinical practice. Bilateral motor priming (BMP) uses bilateral, symmetrical, rhythmic movement to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the more affected one in symmetrical wrist flexion and extension. Active range of motion of the affected wrist is not necessary, and, thus, BMP can be used in severely impaired participants. Beneficial aspects of bilateral motor priming (compared to priming using rTMS and tDCS) include the fact that BMP is: 1) cost-effective; 2) available to a larger pool of individuals due to a paucity of safety concerns; (3) does not require a skilled operator; and (4) can be used the clinic. Previous studies comparing bilateral priming plus therapy found the priming and therapy combination to be more effective than therapy alone. This project compares two groups of randomly assigned participants receiving task specific training (TST). Seventy-six participants will be randomized to receive either fifteen 2-hour sessions (30 hours) of BMP + TST or 30 hours control priming (CP) + training. Participants will attend sessions 3 times per week for 5 weeks with possible missed sessions scheduled at week 6. Outcome measures will be collected at pre-intervention, post-intervention, and follow-up (8 weeks post discharge). Aim 1 will determine the magnitude of change in upper limb impairment and function in chronic stroke survivors who have undergone 5 weeks of BMP+TST. The primary outcome measure is the Fugl-Meyer Test of Upper Extremity Function (FMUE). The secondary outcome is the Chedoke Arm and Hand Activity Index, an assessment of bimanual functional tasks. The investigators expect both groups to improve on behavioral measures from pre-to post-intervention. However, the BMP+TST group is expected to have larger improvements than the CP + TST. The investigators also expect these measures to persist at follow-up (8 weeks post cessation of treatment) in the BMP+TST group but not in CP + TST. Aim 2 will determine the effects of bilateral priming on cortical mechanisms as measured by transcranial magnetic stimulation (TMS). The investigators expect to find changes in TMS parameters that reflect a greater balance of hemispheric excitability in the BMP+TST group only. The hypothesis is that increases in hemispheric excitability will be associated with improvements in the FMUE. Currently, there is no clinically demonstrated long-term effective treatment for individuals with severe chronic upper limb hemiparesis. It is important to identify treatments for this underserved and under-investigated population.
- Conditions
- Stroke
- Being tested
- Bilateral Motor Priming + Task Specific Training (BMP + TST), Control Priming + TST (CP + TST)
- Keywords
- upper limb, occupational therapy, bilateral priming
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Motor Priming + Task Specific Training (BMP + TST)Behavioural
Also called Active-Passive Bilateral Therapy
Priming will always precede task specific training. During bilateral motor priming, the "Rocker" (Exsurgo Bilateral Primer, Aukland, New Zealand) will be used. For the individuals assigned to the bilateral priming group, both hands will be strapped in place in the vertically oriented plates which are attached via a mechanical linkage. They will move both wrists in rhythmic, symmetrical wrist flexion and extension for 15 minutes at a frequency of 1 Hz as cued by a metranome. Subjects do not need to have active flexion and extension of the affected hand as the less affected arm drives the weaker one (through an acutator underneath the surface) in in-phase bilateral symmetrical movement.
Control Priming + TST (CP + TST)Behavioural
Also called Transcutaneous Electric Stimulation
The control priming intervention for the active comparator group will be intermittent cutaneous electric stimulation of the volar aspect of the paretic forearm, using a standard TENS unit delivered for 15 seconds (including 2-second ramp-up, 2-second ramp-down), once per minute, for 15 minutes. Intensity will be minimized
| Study group | Role | What they receive |
|---|---|---|
| Bilateral motor priming + Task specific training (BMP + TST) | Experimental | A combination of bilateral motor priming (BMP) plus task specific training (TST) for 30 hours over 5 weeks. Receives: Behavioral: Bilateral Motor Priming + Task Specific Training (BMP + TST) |
| Control Priming + TST (CP + TST) | Active comparator | The control priming is transcutaneous electric stimulation (TENS) set at a low threshold followed by the same task specific training protocol for 30 hours over 5 weeks. Receives: Behavioral: Control Priming + TST (CP + TST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Myer Test of Upper Extremity Function
Examines upper extremity impairment looking at synergy and isolated movement
Measured: Change in baseline Fugl Myer Score at follow-up (8 weeks after treatment ends)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start20 Jan 2018
- Primary completion7 Feb 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Parallel groups
- Model description
- Patients are stratified by Fugl Meyer score. After stratification, patients will be randomized to one of two groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Corcos, Northwestern University
- Investigators
- Daniel M Corcos, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517657
- Sponsor's protocol ID
- STU00205857
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2018
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
King EC, Trevarrow M, Urday S, Schauer JM, Corcos DM, Stoykov ME. MEP Status is Not Predictive of Response to Upper Limb Training in People With Chronic, Moderate-Severe Hemiparesis Post-Stroke. Neurorehabil Neural Repair. 2025 Jun;39(6):445-451. doi: 10.1177/15459683251327582. Epub 2025 Mar 25.
PubMed 40130687Stoykov ME, Biller OM, Wax A, King E, Schauer JM, Fogg LF, Corcos DM. Bilateral upper extremity motor priming (BUMP) plus task-specific training for severe, chronic upper limb hemiparesis: study protocol for a randomized clinical trial. Trials. 2022 Jun 22;23(1):523. doi: 10.1186/s13063-022-06465-9.
PubMed 35733202
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Priming Plus Task Specific Training for Severe Upper Limb Hemiparesis
- ClinicalTrials.gov ID
- NCT03517657
- Acronym / sponsor ID
- STU00205857
- Conditions
- Stroke
- Keywords
- upper limb, occupational therapy, bilateral priming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Shirley Ryan AbilityLab, University of Chicago
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 7 May 2018 (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 purpose of the study is to determine the best treatment for the arm that has been affected by a stroke. The investigators plan to determine if the arm affected by a stroke will improve with a combination of motor priming and motor training. Motor priming provides a warm up for the brain so that the brain and body will better respond to treatment. There are two types of priming in this study. One is called bilateral motor priming which involves using both hands. Bilateral priming requires that the individual make continuous wrist movements in a low-tech gadget called the Exsurgo primer, a piece of equipment in which each hand goes between two plates that are connected together so that the stronger wrist moves the weaker wrist in and out at the same time. The second type of priming includes use of low intensity stimulation for your affected arm. The investigators expect the bilateral priming group will have more improvement. The study team anticipates enrolling approximately 76 individuals with stroke at Northwestern University and Shirley Ryan AbilityLab into this study. Each participant will have 24 visits. Nine visits will be for evaluation and fifteen for therapy. Each visit will be two to three hours depending on the type of visit and tests being done. Participants who are eligible and want to participate in this study will be randomized (selected by chance) to one of the two groups. The possible groups are: 1) bilateral priming plus motor training and 2) electrical stimulation priming and motor training. Participants are not blinded. Evaluation sessions consist of three separate days of testing and will occur at three time points: (1) before treatment starts; (2) after treatment is completed; and (3) 8 weeks later (follow-up evaluation: visits 22-24). There are three motor assessments, the Neuro-QOL (short form), and an evaluation of cortical excitability using TMS. After a stroke, there is often an imbalance of excitability between the affected and less affected parts of the brain. The imbalance will be measured using Transcranial Magnetic Stimulation (TMS), a technique used in neurorehabilitation research. TMS will not be used for treatment. There will also be a grip termination evaluation. This test will determine how long it takes to relax the affected hand after gripping an object.
Detailed description
Priming techniques to enhance use dependent plasticity have been examined in stroke rehabilitation research. Priming can upregulate ipsilesional cortex and/or down regulate contralesional cortex to improve effectiveness of subsequent therapy. Most priming techniques are costly and approved only for research. Here, we describe a priming technique that is cost-effective and has the potential to significantly change clinical practice. Bilateral motor priming (BMP) uses bilateral, symmetrical, rhythmic movement to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the more affected one in symmetrical wrist flexion and extension. Active range of motion of the affected wrist is not necessary, and, thus, BMP can be used in severely impaired participants. Beneficial aspects of bilateral motor priming (compared to priming using rTMS and tDCS) include the fact that BMP is: 1) cost-effective; 2) available to a larger pool of individuals due to a paucity of safety concerns; (3) does not require a skilled operator; and (4) can be used the clinic. Previous studies comparing bilateral priming plus therapy found the priming and therapy combination to be more effective than therapy alone. This project compares two groups of randomly assigned participants receiving task specific training (TST). Seventy-six participants will be randomized to receive either fifteen 2-hour sessions (30 hours) of BMP + TST or 30 hours control priming (CP) + training. Participants will attend sessions 3 times per week for 5 weeks with possible missed sessions scheduled at week 6. Outcome measures will be collected at pre-intervention, post-intervention, and follow-up (8 weeks post discharge). Aim 1 will determine the magnitude of change in upper limb impairment and function in chronic stroke survivors who have undergone 5 weeks of BMP+TST. The primary outcome measure is the Fugl-Meyer Test of Upper Extremity Function (FMUE). The secondary outcome is the Chedoke Arm and Hand Activity Index, an assessment of bimanual functional tasks. The investigators expect both groups to improve on behavioral measures from pre-to post-intervention. However, the BMP+TST group is expected to have larger improvements than the CP + TST. The investigators also expect these measures to persist at follow-up (8 weeks post cessation of treatment) in the BMP+TST group but not in CP + TST. Aim 2 will determine the effects of bilateral priming on cortical mechanisms as measured by transcranial magnetic stimulation (TMS). The investigators expect to find changes in TMS parameters that reflect a greater balance of hemispheric excitability in the BMP+TST group only. The hypothesis is that increases in hemispheric excitability will be associated with improvements in the FMUE. Currently, there is no clinically demonstrated long-term effective treatment for individuals with severe chronic upper limb hemiparesis. It is important to identify treatments for this underserved and under-investigated population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are stratified by Fugl Meyer score. After stratification, patients will be randomized to one of two groups
| Arm | Type | Receives |
|---|---|---|
| Bilateral motor priming + Task specific training (BMP + TST) | Experimental | Behavioral: Bilateral Motor Priming + Task Specific Training (BMP + TST)A combination of bilateral motor priming (BMP) plus task specific training (TST) for 30 hours over 5 weeks. |
| Control Priming + TST (CP + TST) | Active comparator | Behavioral: Control Priming + TST (CP + TST)The control priming is transcutaneous electric stimulation (TENS) set at a low threshold followed by the same task specific training protocol for 30 hours over 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- FMUE TEST score of 23 to 40
- evidence of stroke without involvement of cerebellum at least 6 months prior to enrollment;
- 0-3 wrist flexion/wrist extension on Modified Ashworth Scale
Key exclusion criteria (11 listed)
- orthopedic conditions of less affected or affected wrist
- MMSE of lower than 21
- metal implant or fragments in head or neck area
- history of seizures, epilepsy or convulsions
- previous concussion associated with LOC
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 |
|---|---|---|
| Bilateral Motor Priming + Task Specific Training (BMP + TST)Also: Active-Passive Bilateral TherapyPriming will always precede task specific training. During bilateral motor priming, the "Rocker" (Exsurgo Bilateral Primer, Aukland, New Zealand) will be used. For the individuals assigned to the bilateral priming group, both hands will be strapped in place in the vertically oriented plates which are attached via a mechanical linkage. They will move both wrists in rhythmic, symmetrical wrist flexion and extension for 15 minutes at a frequency of 1 Hz as cued by a metranome. Subjects do not need to have active flexion and extension of the affected hand as the less affected arm drives the weaker one (through an acutator underneath the surface) in in-phase bilateral symmetrical movement. | Behavioural | Bilateral motor priming + Task specific training (BMP + TST) |
| Control Priming + TST (CP + TST)Also: Transcutaneous Electric StimulationThe control priming intervention for the active comparator group will be intermittent cutaneous electric stimulation of the volar aspect of the paretic forearm, using a standard TENS unit delivered for 15 seconds (including 2-second ramp-up, 2-second ramp-down), once per minute, for 15 minutes. Intensity will be minimized | Behavioural | Control Priming + TST (CP + TST) |
Primary outcome
Fugl Myer Test of Upper Extremity Function
Time frame: Change in baseline Fugl Myer Score at follow-up (8 weeks after treatment ends)
Examines upper extremity impairment looking at synergy and isolated movement
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 29 Apr 2025.
- Derived from this study: PubMed 40130687King EC, Trevarrow M, Urday S, Schauer JM, Corcos DM, Stoykov ME. MEP Status is Not Predictive of Response to Upper Limb Training in People With Chronic, Moderate-Severe Hemiparesis Post-Stroke. Neurorehabil Neural Repair. 2025 Jun;39(6):445-451. doi: 10.1177/15459683251327582. Epub 2025 Mar 25.
- Derived from this study: PubMed 35733202Stoykov ME, Biller OM, Wax A, King E, Schauer JM, Fogg LF, Corcos DM. Bilateral upper extremity motor priming (BUMP) plus task-specific training for severe, chronic upper limb hemiparesis: study protocol for a randomized clinical trial. Trials. 2022 Jun 22;23(1):523. doi: 10.1186/s13063-022-06465-9.
- 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.
Daniel M Corcos, PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Motor Priming + Task Specific Training (BMP + TST) in people with Stroke, run by Northwestern University at 2 sites 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 11 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fugl Myer Test of Upper Extremity Function (time frame: Change in baseline Fugl Myer Score at follow-up (8 weeks after treatment ends)). 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 NCT03517657, which also lists 2 linked publications.
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 29 Apr 2025.