StrokeNCT05020080
Operant Conditioning for Rehabilitation After Stroke
A study testing Operant conditioning of motor evoked potentials in people with Stroke, run by University of Houston at 1 site in United States.
Trial summary
The purposes of this study include: 1. To test if multiple upper extremity muscles represented within a discrete primary motor cortex site reflect existing muscle synergies after stroke. 2. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Operant conditioning of motor evoked potentials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2022to 12 Jul 2024
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female whose age range between 40 and 75
- no known neurological injuries
- male or female hemiparetic chronic stroke survivors;
- age ranging between 40-75 year;
- with single unilateral ischemic or hemorrhagic middle cerebral artery stroke;
- neurologically stable for >6 months;
Show all 12Show fewer
- have an expectation that current medication will be maintained without changes for at least 3 months. Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted;
- with moderate-to-severe impairments (FMA<45/66);
- with weak wrist extension (i.e., <4 by manual muscle strength test);
- eligible to receive transcranial magnetic stimulation (TMS), and extensor carpi radialis (ECR) motor evoked potential (MEP) must be present in the more affected arm;
- without severe spasticity (Modified Ashworth (MA) <4);
- have not received botulinum toxin on the impaired arm within 3 months.
Who cannot join
- have an orthopedic disorder involving upper limbs;
- have a history of any neurologic disease;
- have any history of epilepsy of the potential participants and/or their family members;
- had an adverse reaction to TMS;
- are unable to consent;
- are pregnant.
Show all 24Show fewer
- have an orthopedic disorder involving upper limbs;
- have no measurable MEP elicited in the ECR;
- unable to produce any voluntary ECR EMG activity;
- cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol (Montreal Cognitive Assessment (MoCA) score < 26);
- a history of another neurologic disease;
- a history of vertigo;
- a history of vestibular or cochlear dysfunction;
- have a history of convulsion or a seizure;
- anesthesia of joint position sense in upper limbs;
- are pregnant or have a chance that they might be (self-reported);
- have metal in the brain/skull (except titanium; e.g. splinters, fragments, clips, etc.);
- have cochlear implants;
- have an implanted neurostimulator (DBS, epidural/subdural, VNS);
- have a cardiac pacemaker or intracardiac lines or metal in the body;
- have a medication infusion device;
- are taking any medications to treat mental illness;
- have spinal or ventricular derivations;
- had an adverse reaction to TMS.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Houston
Houston, Texas, 77204
Jinsook Roh, PhD, 713-743-2578, jroh@central.uh.edu
Manuel A Portilla-Jiménez, MS, BME, 3467194921, maporti4@cougarnet.uh.edu
About this study
Official title: Examining the Effects of Operant Conditioning of Wrist Extensor MEP on Arm Intermuscular Coordination After Stroke
The purposes of this study include:
- To test if multiple upper extremity muscles represented within a discrete primary motor cortex site reflect existing muscle synergies after stroke.
- To test if altered muscle synergies and intermuscular coordination are malleable to motor evoked potential conditioning that induces corticospinal plasticity for the targeted muscle, wrist extensor carpi radialis
Read the detailed description
Stroke is a leading cause of long-term disabilities in the U.S., which can markedly impact the function of the upper extremity (UE). One of the major UE motor impairments is abnormal intermuscular coordination, which leads to impaired post-stroke function and life participation. Also, relatively little is understood about how stroke affects the corticospinal innervation of multiple UE muscles, visualized as multi-muscle motor evoked potentials (MEPs) to transcranial magnetic stimulation (TMS) of the primary motor cortex (M1), and its association with intermuscular coordination and impaired UE motor function in stroke. Some studies have shown that improvement in corticospinal excitability for the affected limb may be able to improve intermuscular coordination and enhance motor function recovery after stroke. Operant conditioning is a method that can be used to produce not only targeted plasticity but also wider beneficial plasticity in multiple spinal/supraspinal pathways. Recent studies have shown that MEP operant up-conditioning can increase the corticospinal excitability for the targeted muscle in people with SCI in the UE and lower extremity (LE) and in the LE of multiple sclerosis.
For the aim 1 of the project, MEPs elicited by TMS will be applied at the hot spot for the wrist ECR. EMG signal from 15 UE muscle will be collected simultaneously during isometric force generation tasks. This aim will enroll 10 age-matched (age of 40-75 yo) healthy adult and 10 adult (age of 40-75 yo) stroke survivors. Each participant will have a single measurement session.
For the aim 2 of the project, 4 randomized out of 10 stroke survivors will perform operant conditioning method of the wrist ECR; also, assessment of the intermuscular coordination, UE Fugl-Meyer (FM), and Action Research Arm Test (ARAT) will be performed. Participants will have three visits per week for 10 weeks for training session. Finally, to test retention of the intervention effect, they will perform two assessment sessions one and three months after finishing the training.
- Conditions
- Stroke
- Being tested
- Operant conditioning of motor evoked potentials
- Keywords
- operant conditioning, motor evoked potential, transcranial magnetic stimulation, muscle synergy, motor control, motor coordination
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operant conditioning of motor evoked potentialsOther
MEPs elicited by TMS will be applied at the hot spot for the wrist extensor carpi radialis. During training trials, participants will be asked to increase the size of their MEP response. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT.
| Study group | Role | What they receive |
|---|---|---|
| ECR MEP conditioning - Stroke | Experimental | MEP operant conditioning of ECR in stroke survivors Receives: Other: Operant conditioning of motor evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intermuscular coordination patterns (ICoPs)
EMGs will be recorded from 15 muscles. To assess whether wrist extensor MEP OC induces changes in the composition of intermuscular coordination patterns, non-negative matrix factorization will be applied to EMGs to identify and compare ICoPs.
Measured: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
Change in motor evoked potential (MEP)
To measure the amount of the corticospinal excitability of the target muscle (extensor carpi radialis) and its antagonist (flexor carpi radialis), MEPs will be elicited while the participant provides ~30% maximum voluntary contraction level of each muscle background electromyographic (EMG) signals. For all trials, transcranial magnetic stimulation at ~10% above active motor threshold at the optimum location of the cortex will be used to elicit the MEP.
Measured: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
Change in Fugl-Meyer Assessment (FMA) score
To measure severity of motor impairment after stroke, FMA will be performed in the human upper extremity. FMA is commonly used to assess severity of motor impairment and motor recovery. The maximum FMA upper extremity motor score is 66 (i.e., 0: complete motor impairment; 66: normal motor performance). Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Measured: Time Frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
Change in Action Research Arm Test (ARAT) score
To measure motor function after stroke, ARAT will be performed in the human upper extremity. 19 Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
Measured: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
Secondary outcomes (1)
Change in force errors that occur during isometric wrist force tracking tasks
As a mechanistic outcome, force errors that occur during isometric wrist force tracking tasks (ramp up-hold-ramp down) will be recorded to assess wrist motor control function that can change as corticospinal excitability increases through MEP up-conditioning.
Measured: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start13 Jan 2022
- Primary completion12 Jul 2024 (estimated)
- Study completion12 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Neuromodulation for Rehabilitation
- Responsible party
- Principal investigator, Jinsook Roh, University of Houston
- Investigators
- Jinsook Roh, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020080
- Sponsor's protocol ID
- STUDY00002996
- Status last verified
- Nov 2023
- First submitted
- 13 Aug 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ting LH, Chiel HJ, Trumbower RD, Allen JL, McKay JL, Hackney ME, Kesar TM. Neuromechanical principles underlying movement modularity and their implications for rehabilitation. Neuron. 2015 Apr 8;86(1):38-54. doi: 10.1016/j.neuron.2015.02.042.
PubMed 25856485McMorland AJ, Runnalls KD, Byblow WD. A neuroanatomical framework for upper limb synergies after stroke. Front Hum Neurosci. 2015 Feb 16;9:82. doi: 10.3389/fnhum.2015.00082. eCollection 2015.
PubMed 25762917Tresch MC, Jarc A. The case for and against muscle synergies. Curr Opin Neurobiol. 2009 Dec;19(6):601-7. doi: 10.1016/j.conb.2009.09.002. Epub 2009 Oct 12.
PubMed 19828310Roh J, Rymer WZ, Perreault EJ, Yoo SB, Beer RF. Alterations in upper limb muscle synergy structure in chronic stroke survivors. J Neurophysiol. 2013 Feb;109(3):768-81. doi: 10.1152/jn.00670.2012. Epub 2012 Nov 14.
PubMed 23155178Roh J, Rymer WZ, Beer RF. Evidence for altered upper extremity muscle synergies in chronic stroke survivors with mild and moderate impairment. Front Hum Neurosci. 2015 Feb 11;9:6. doi: 10.3389/fnhum.2015.00006. eCollection 2015.
PubMed 25717296Thompson AK, Fiorenza G, Smyth L, Favale B, Brangaccio J, Sniffen J. Operant conditioning of the motor-evoked potential and locomotion in people with and without chronic incomplete spinal cord injury. J Neurophysiol. 2019 Mar 1;121(3):853-866. doi: 10.1152/jn.00557.2018. Epub 2019 Jan 9.
PubMed 30625010Thompson AK, Cote RH, Sniffen JM, Brangaccio JA. Operant conditioning of the tibialis anterior motor evoked potential in people with and without chronic incomplete spinal cord injury. J Neurophysiol. 2018 Dec 1;120(6):2745-2760. doi: 10.1152/jn.00362.2018. Epub 2018 Sep 12.
PubMed 30207863Thompson AK, Favale BM, Velez J, Falivena P. Operant Up-Conditioning of the Tibialis Anterior Motor-Evoked Potential in Multiple Sclerosis: Feasibility Case Studies. Neural Plast. 2018 Jul 15;2018:4725393. doi: 10.1155/2018/4725393. eCollection 2018.
PubMed 30123249
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Operant Conditioning of Wrist Extensor MEP on Arm Intermuscular Coordination After Stroke
- ClinicalTrials.gov ID
- NCT05020080
- Acronym / sponsor ID
- STUDY00002996
- Conditions
- Stroke
- Keywords
- operant conditioning, motor evoked potential, transcranial magnetic stimulation, muscle synergy, motor control, motor coordination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Center of Neuromodulation for Rehabilitation
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 12 Jul 2024 (estimated)
- Study completion
- 12 Jul 2024 (estimated)
- First posted
- 25 Aug 2021 (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 purposes of this study include:
- To test if multiple upper extremity muscles represented within a discrete primary motor cortex site reflect existing muscle synergies after stroke.
- To test if altered muscle synergies and intermuscular coordination are malleable to motor evoked potential conditioning that induces corticospinal plasticity for the targeted muscle, wrist extensor carpi radialis
Detailed description
Stroke is a leading cause of long-term disabilities in the U.S., which can markedly impact the function of the upper extremity (UE). One of the major UE motor impairments is abnormal intermuscular coordination, which leads to impaired post-stroke function and life participation. Also, relatively little is understood about how stroke affects the corticospinal innervation of multiple UE muscles, visualized as multi-muscle motor evoked potentials (MEPs) to transcranial magnetic stimulation (TMS) of the primary motor cortex (M1), and its association with intermuscular coordination and impaired UE motor function in stroke. Some studies have shown that improvement in corticospinal excitability for the affected limb may be able to improve intermuscular coordination and enhance motor function recovery after stroke. Operant conditioning is a method that can be used to produce not only targeted plasticity but also wider beneficial plasticity in multiple spinal/supraspinal pathways. Recent studies have shown that MEP operant up-conditioning can increase the corticospinal excitability for the targeted muscle in people with SCI in the UE and lower extremity (LE) and in the LE of multiple sclerosis.
For the aim 1 of the project, MEPs elicited by TMS will be applied at the hot spot for the wrist ECR. EMG signal from 15 UE muscle will be collected simultaneously during isometric force generation tasks. This aim will enroll 10 age-matched (age of 40-75 yo) healthy adult and 10 adult (age of 40-75 yo) stroke survivors. Each participant will have a single measurement session.
For the aim 2 of the project, 4 randomized out of 10 stroke survivors will perform operant conditioning method of the wrist ECR; also, assessment of the intermuscular coordination, UE Fugl-Meyer (FM), and Action Research Arm Test (ARAT) will be performed. Participants will have three visits per week for 10 weeks for training session. Finally, to test retention of the intervention effect, they will perform two assessment sessions one and three months after finishing the training.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECR MEP conditioning - Stroke | Experimental | Other: Operant conditioning of motor evoked potentialsMEP operant conditioning of ECR in stroke survivors |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female whose age range between 40 and 75
- no known neurological injuries
- male or female hemiparetic chronic stroke survivors;
- age ranging between 40-75 year;
- with single unilateral ischemic or hemorrhagic middle cerebral artery stroke;
Key exclusion criteria (24 listed)
- have an orthopedic disorder involving upper limbs;
- have a history of any neurologic disease;
- have any history of epilepsy of the potential participants and/or their family members;
- had an adverse reaction to TMS;
- are unable to consent;
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 |
|---|---|---|
| Operant conditioning of motor evoked potentialsMEPs elicited by TMS will be applied at the hot spot for the wrist extensor carpi radialis. During training trials, participants will be asked to increase the size of their MEP response. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT. | Other | ECR MEP conditioning - Stroke |
Primary outcome
Change in intermuscular coordination patterns (ICoPs)
Time frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
EMGs will be recorded from 15 muscles. To assess whether wrist extensor MEP OC induces changes in the composition of intermuscular coordination patterns, non-negative matrix factorization will be applied to EMGs to identify and compare ICoPs.
Change in motor evoked potential (MEP)
Time frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
To measure the amount of the corticospinal excitability of the target muscle (extensor carpi radialis) and its antagonist (flexor carpi radialis), MEPs will be elicited while the participant provides ~30% maximum voluntary contraction level of each muscle background electromyographic (EMG) signals. For all trials, transcranial magnetic stimulation at ~10% above active motor threshold at the optimum location of the cortex will be used to elicit the MEP.
Change in Fugl-Meyer Assessment (FMA) score
Time frame: Time Frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
To measure severity of motor impairment after stroke, FMA will be performed in the human upper extremity. FMA is commonly used to assess severity of motor impairment and motor recovery. The maximum FMA upper extremity motor score is 66 (i.e., 0: complete motor impairment; 66: normal motor performance). Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Change in Action Research Arm Test (ARAT) score
Time frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
To measure motor function after stroke, ARAT will be performed in the human upper extremity. 19 Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
1 secondary outcome
Change in force errors that occur during isometric wrist force tracking tasks
Time frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 25856485Ting LH, Chiel HJ, Trumbower RD, Allen JL, McKay JL, Hackney ME, Kesar TM. Neuromechanical principles underlying movement modularity and their implications for rehabilitation. Neuron. 2015 Apr 8;86(1):38-54. doi: 10.1016/j.neuron.2015.02.042.
- Background: PubMed 25762917McMorland AJ, Runnalls KD, Byblow WD. A neuroanatomical framework for upper limb synergies after stroke. Front Hum Neurosci. 2015 Feb 16;9:82. doi: 10.3389/fnhum.2015.00082. eCollection 2015.
- Background: PubMed 19828310Tresch MC, Jarc A. The case for and against muscle synergies. Curr Opin Neurobiol. 2009 Dec;19(6):601-7. doi: 10.1016/j.conb.2009.09.002. Epub 2009 Oct 12.
- Background: PubMed 23155178Roh J, Rymer WZ, Perreault EJ, Yoo SB, Beer RF. Alterations in upper limb muscle synergy structure in chronic stroke survivors. J Neurophysiol. 2013 Feb;109(3):768-81. doi: 10.1152/jn.00670.2012. Epub 2012 Nov 14.
- Background: PubMed 25717296Roh J, Rymer WZ, Beer RF. Evidence for altered upper extremity muscle synergies in chronic stroke survivors with mild and moderate impairment. Front Hum Neurosci. 2015 Feb 11;9:6. doi: 10.3389/fnhum.2015.00006. eCollection 2015.
- Background: PubMed 30625010Thompson AK, Fiorenza G, Smyth L, Favale B, Brangaccio J, Sniffen J. Operant conditioning of the motor-evoked potential and locomotion in people with and without chronic incomplete spinal cord injury. J Neurophysiol. 2019 Mar 1;121(3):853-866. doi: 10.1152/jn.00557.2018. Epub 2019 Jan 9.
- Background: PubMed 30207863Thompson AK, Cote RH, Sniffen JM, Brangaccio JA. Operant conditioning of the tibialis anterior motor evoked potential in people with and without chronic incomplete spinal cord injury. J Neurophysiol. 2018 Dec 1;120(6):2745-2760. doi: 10.1152/jn.00362.2018. Epub 2018 Sep 12.
- Background: PubMed 30123249Thompson AK, Favale BM, Velez J, Falivena P. Operant Up-Conditioning of the Tibialis Anterior Motor-Evoked Potential in Multiple Sclerosis: Feasibility Case Studies. Neural Plast. 2018 Jul 15;2018:4725393. doi: 10.1155/2018/4725393. eCollection 2018.
- 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.
Jinsook Roh, Ph.D. principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operant conditioning of motor evoked potentials in people with Stroke, run by University of Houston 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 12 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsook Roh, PhD (7137432578, jroh@Central.UH.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intermuscular coordination patterns (ICoPs) (time frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively). 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?
On the ClinicalTrials.gov record for NCT05020080, which also lists 8 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 Nov 2023.