Upper Limb Hemiparesis Following StrokeNCT06950593
Transcutaneous Electrical Stimulation for Stroke Patients
A study testing Task Specific Training (TST) and Transcutaneous electrical spinal cord stimulation (TESS) in people with Upper Limb Hemiparesis Following Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Hemiparesis Following Stroke
- What is being tested?
- Task Specific Training (TST) and Transcutaneous electrical spinal cord stimulation (TESS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years or older
- able and willing to give written consent and comply with study procedures
- at least 6 months post-stroke
- hemiplegia secondary to stroke
- UE Fugle Meyer Assessment <35
- not currently receiving regular occupational therapy services
- participant has received clearance from physician to participate in study
- participant has at least a rudimentary comprehension of English
Who cannot join
- botox injection in upper extremity within the last 4 months
- modified ashworth score of 4 in any joint of the affected limb
- pregnant or nursing
- using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD), or anti-spasticity implantable pumps, or cochlear implants
- unhealed bone fractures
- severe contractures in the upper extremities
Show all 12Show fewer
- active cancer or cancer remission less than 5 years
- orthopedic dysfunction, injury, or surgery that would impact the individual's ability to use the upper extremities
- recent procedure or operation of the spinal cord within the past year
- traumatic brain injury or neurological conditions that would impact the study
- skull fracture that has developed within the past 6 months
- non-English speakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
About this study
Official title: Upper Limb Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. It will compare outcomes measures between individuals who receive upper limb task specific training with TESS and individuals who receive task specific training of the upper limb with Sham, or fake, TESS.
Read the detailed description
Upper limb (UL) hemiparesis is the most common post-stroke disability. Currently, there is no treatment used in the clinic that has shown to be efficacious for 75% of individuals who have moderate to severe UL hemiparesis. There are no interventions for individuals with moderate to severe hemiparesis that have demonstrated superiority in comparison to standard care. These stroke patients often have increased spasticity and muscle weakness, resulting in chronic upper limb dysfunction. We are proposing an alternative strategy to improve upper limb function after stroke: transcutaneous electrical stimulation of the spinal cord (TESS). Our objective is to evaluate the feasibility and neural effects of transcutaneous spinal stimulation plus task specific training in a two-arm study with three time points (pre-/post-intervention and follow-up). We will recruit 14 chronic post-stroke participants who will receive 15 sessions of either TESS plus task specific training or Sham TESS plus task specific training. Our long-term research goal is to use TESS as a therapeutic strategy, combined with task specific training, to improve upper limb impairment and function in chronic stroke survivors. Our central hypothesis is that excitation of spinal circuitry by spinal stimulation will result in more effective motor control that will improve volitional upper limb movement (as compared to sham stimulation plus task specific training). This hypothesis is based on published work in cervical spinal cord injury.
- Conditions
- Upper Limb Hemiparesis Following Stroke
- Being tested
- Task Specific Training (TST), Transcutaneous electrical spinal cord stimulation (TESS), Sham transcutaneous electrical spinal cord stimulation (Sham TESS)
- Keywords
- upper limb hemiparesis, stroke, transcutaneous spinal cord stimulation (TESS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task Specific Training (TST)Other
Task specific training activities are types of activities that may be used in standard of care for stroke rehabilitation. Tasks will be completed in sitting or standing. As is usual in studies for upper limb hemiparesis, study participants will be picking up objects with their affected hands. They will work on grasp, grasp-lift of objects, release of objects, reaching and grasping, and reaching without grasping.
Transcutaneous electrical spinal cord stimulation (TESS)Other
The Digitimer DS8R Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation. The stimulus intensity used during the intervention will be determined based on individual maximum tolerance. We expect this current amplitude to be between 10mA and 100mA. Stimulation time will be standardized to a 30min duration during which the participant will perform task specific training tasks.
Sham transcutaneous electrical spinal cord stimulation (Sham TESS)Other
The Sham TESS intervention will utilize the same device and setup as the true TESS intervention. However, after turning on the stimulation and reaching the appropriate intensity, the stimulation will be ramped down and turned off for the remainder of the treatment session. The participant will be told that the stimulation was brought down to a sub-threshold level in order to maintain treatment group blinding.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | This group receives task specific training and transcutaneous spinal cord stimulation (TESS) during treatment sessions. TESS is applied via electrodes placed vertically over the spinous processes of C5-C6. The stimulation will be adjusted within a range of 10mA to 100mA based on participant tolerance and will be delivered for 30 minutes per training session. Receives: Other: Task Specific Training (TST); Other: Transcutaneous electrical spinal cord stimulation (TESS) |
| Comparator Group | Active comparator | This group receives task specific training without real TESS during treatment sessions. Instead, they receive Sham TESS, which is a placebo version in which the electrodes are applied and the stimulation is turned on so that the patient can feel it, and then ramped down to zero for the duration of the session. Receives: Other: Task Specific Training (TST); Other: Sham transcutaneous electrical spinal cord stimulation (Sham TESS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Test of Upper Extremity Function (FMUE)
The FMUE is an impairment scale that addresses both synergy and isolated movements of the upper limb. The subscales include reflex movements, flexor synergy, extensor synergy, movements out of synergy, combining synergies, wrist, hand, and coordination subscales. The total score ranges from 0 to 66 with higher scores indicating greater function.
Measured: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
Modified Ashworth Scale (MAS)
The MAS is a test of muscle spasticity and increases in muscle tone. The scores range from 0-4 for each test item, depending on the increase in muscle tone when completing quick movement, or resting muscle tone.
Measured: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
Grip Strength
Grip strength will be an outcome measure measured via the Jamar Dynamometer. The procedure will consist of 3 tests of maximum grip strength force. Participants will be given ~30 seconds to 1 minute of rest time for each hand in between tests. The individual will maintain ~90 degrees of elbow flexion, 0 degrees of shoulder flexion, and a neutral wrist position while completing the testing.
Measured: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
Chedoke Arm & Hand Activity Index (CAHAI-9)
The CAHAI 9 is a test of bimanual function. There are nine activities including opening a jar, pouring water, drawing a line with a ruler, buttoning a shirt, using the telephone, wringing out a washcloth, applying toothpaste to a toothbrush, cutting food, and drying one's back with a bath towel. The scale ranges from 1 to 7 for each test item and are graded by the amount of use of the affected hand.
Measured: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
Canadian Occupational Performance Measure (COPM)
The COPM is a patient-reported outcome measure in which the participant will be asked to rate their ability to perform tasks of everyday living. Specifically, the assessment asks participants to identify tasks that they find value in completing, rank their priority, and rank their ability to perform them.
Measured: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
Secondary outcomes (3)
Motor evoked potential status (MEPs)
MEP status is a binary TMS stimulation measure for evaluation of the treatment target or, in this study, corticospinal excitability. There will be an attempt to elicit active MEPs in the biceps, ECR, and FDI. The MEP status of each of the 3 muscles will be tested by finding a hot spot using a single pulse TMS. Individual muscles will be labeled as MEP(-) or MEP(+). The criteria for being MEP(+) is any amplitude present in at least 50% (5/10) of the TMS stimuli using stimulation up to 100% maximal stimulator output.
Measured: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation
Maximum Voluntary Contraction (MVC)
Electromyographic (EMG) recordings will be recorded through surface electrodes secured to th skin over the belly of each muscle. In order to obtain MVCs of each affected upper limb muscle, subjects will perform three contractions of elbow flexion, wrist extension, and finger abduction individually. MVCs will be recorded for 3-5s, separated by ~60s of rest.
Measured: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation
H-reflex
The H-reflex is used to assess the reflexive reaction of the flexor carpi radialis muscle after stimulating the sensory nerve (Ia afferent) fibers. Percutaneous electrical stimulation of the median nerve will be delivered (using 1 ms rectangular electrical stimulus, DS7AH, Digitimer Ltd.) through bipolar electrodes (7-mm stainless steel) just proximal to the elbow. Stimulus intensities will be increased in steps of 0.05 mA, starting below H-reflex threshold and increasing up to measure the H-max and M-max at rest (0.25 Hz). The H-max and Mmax will be measured as peak-to-peak amplitude of the non-rectified response in control subjects and both arms of individuals.
Measured: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start18 Aug 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Upper Limb Hemiparesis Following 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This interventional study uses a randomized, single-blind (evaluator masked), parallel, two-arm experimental design with an appropriate active comparator.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Ellen Stoykov, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950593
- Sponsor's protocol ID
- STU00220717
- Status last verified
- Aug 2025
- First submitted
- 20 Mar 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095.
PubMed 17077374Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Barreca S, Gowland CK, Stratford P, Huijbregts M, Griffiths J, Torresin W, Dunkley M, Miller P, Masters L. Development of the Chedoke Arm and Hand Activity Inventory: theoretical constructs, item generation, and selection. Top Stroke Rehabil. 2004 Fall;11(4):31-42. doi: 10.1310/JU8P-UVK6-68VW-CF3W.
PubMed 15592988Benavides FD, Jo HJ, Lundell H, Edgerton VR, Gerasimenko Y, Perez MA. Cortical and Subcortical Effects of Transcutaneous Spinal Cord Stimulation in Humans with Tetraplegia. J Neurosci. 2020 Mar 25;40(13):2633-2643. doi: 10.1523/JNEUROSCI.2374-19.2020. Epub 2020 Jan 29.
PubMed 31996455Stoykov ME, King E, David FJ, Vatinno A, Fogg L, Corcos DM. Bilateral motor priming for post stroke upper extremity hemiparesis: A randomized pilot study. Restor Neurol Neurosci. 2020;38(1):11-22. doi: 10.3233/RNN-190943.
PubMed 31609714
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
- ClinicalTrials.gov ID
- NCT06950593
- Acronym / sponsor ID
- STU00220717
- Conditions
- Upper Limb Hemiparesis Following Stroke
- Keywords
- upper limb hemiparesis, stroke, transcutaneous spinal cord stimulation (TESS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 30 Apr 2025 (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.
This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. It will compare outcomes measures between individuals who receive upper limb task specific training with TESS and individuals who receive task specific training of the upper limb with Sham, or fake, TESS.
Detailed description
Upper limb (UL) hemiparesis is the most common post-stroke disability. Currently, there is no treatment used in the clinic that has shown to be efficacious for 75% of individuals who have moderate to severe UL hemiparesis. There are no interventions for individuals with moderate to severe hemiparesis that have demonstrated superiority in comparison to standard care. These stroke patients often have increased spasticity and muscle weakness, resulting in chronic upper limb dysfunction. We are proposing an alternative strategy to improve upper limb function after stroke: transcutaneous electrical stimulation of the spinal cord (TESS). Our objective is to evaluate the feasibility and neural effects of transcutaneous spinal stimulation plus task specific training in a two-arm study with three time points (pre-/post-intervention and follow-up). We will recruit 14 chronic post-stroke participants who will receive 15 sessions of either TESS plus task specific training or Sham TESS plus task specific training. Our long-term research goal is to use TESS as a therapeutic strategy, combined with task specific training, to improve upper limb impairment and function in chronic stroke survivors. Our central hypothesis is that excitation of spinal circuitry by spinal stimulation will result in more effective motor control that will improve volitional upper limb movement (as compared to sham stimulation plus task specific training). This hypothesis is based on published work in cervical spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This interventional study uses a randomized, single-blind (evaluator masked), parallel, two-arm experimental design with an appropriate active comparator.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Other: Task Specific Training (TST), Other: Transcutaneous electrical spinal cord stimulation (TESS)This group receives task specific training and transcutaneous spinal cord stimulation (TESS) during treatment sessions. TESS is applied via electrodes placed vertically over the spinous processes of C5-C6. The stimulation will be adjusted within a range of 10mA to 100mA based on participant tolerance and will be delivered for 30 minutes per training session. |
| Comparator Group | Active comparator | Other: Task Specific Training (TST), Other: Sham transcutaneous electrical spinal cord stimulation (Sham TESS)This group receives task specific training without real TESS during treatment sessions. Instead, they receive Sham TESS, which is a placebo version in which the electrodes are applied and the stimulation is turned on so that the patient can feel it, and then ramped down to zero for the duration of the session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years or older
- able and willing to give written consent and comply with study procedures
- at least 6 months post-stroke
- hemiplegia secondary to stroke
- UE Fugle Meyer Assessment <35
Key exclusion criteria (12 listed)
- botox injection in upper extremity within the last 4 months
- modified ashworth score of 4 in any joint of the affected limb
- pregnant or nursing
- using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD), or anti-spasticity implantable pumps, or cochlear implants
- unhealed bone fractures
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 |
|---|---|---|
| Task Specific Training (TST)Task specific training activities are types of activities that may be used in standard of care for stroke rehabilitation. Tasks will be completed in sitting or standing. As is usual in studies for upper limb hemiparesis, study participants will be picking up objects with their affected hands. They will work on grasp, grasp-lift of objects, release of objects, reaching and grasping, and reaching without grasping. | Other | Comparator Group, Experimental Group |
| Transcutaneous electrical spinal cord stimulation (TESS)The Digitimer DS8R Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation. The stimulus intensity used during the intervention will be determined based on individual maximum tolerance. We expect this current amplitude to be between 10mA and 100mA. Stimulation time will be standardized to a 30min duration during which the participant will perform task specific training tasks. | Other | Experimental Group |
| Sham transcutaneous electrical spinal cord stimulation (Sham TESS)The Sham TESS intervention will utilize the same device and setup as the true TESS intervention. However, after turning on the stimulation and reaching the appropriate intensity, the stimulation will be ramped down and turned off for the remainder of the treatment session. The participant will be told that the stimulation was brought down to a sub-threshold level in order to maintain treatment group blinding. | Other | Comparator Group |
Primary outcome
Fugl-Meyer Test of Upper Extremity Function (FMUE)
Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
The FMUE is an impairment scale that addresses both synergy and isolated movements of the upper limb. The subscales include reflex movements, flexor synergy, extensor synergy, movements out of synergy, combining synergies, wrist, hand, and coordination subscales. The total score ranges from 0 to 66 with higher scores indicating greater function.
Modified Ashworth Scale (MAS)
Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
The MAS is a test of muscle spasticity and increases in muscle tone. The scores range from 0-4 for each test item, depending on the increase in muscle tone when completing quick movement, or resting muscle tone.
Grip Strength
Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
Grip strength will be an outcome measure measured via the Jamar Dynamometer. The procedure will consist of 3 tests of maximum grip strength force. Participants will be given ~30 seconds to 1 minute of rest time for each hand in between tests. The individual will maintain ~90 degrees of elbow flexion, 0 degrees of shoulder flexion, and a neutral wrist position while completing the testing.
Chedoke Arm & Hand Activity Index (CAHAI-9)
Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
The CAHAI 9 is a test of bimanual function. There are nine activities including opening a jar, pouring water, drawing a line with a ruler, buttoning a shirt, using the telephone, wringing out a washcloth, applying toothpaste to a toothbrush, cutting food, and drying one's back with a bath towel. The scale ranges from 1 to 7 for each test item and are graded by the amount of use of the affected hand.
Canadian Occupational Performance Measure (COPM)
Time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
The COPM is a patient-reported outcome measure in which the participant will be asked to rate their ability to perform tasks of everyday living. Specifically, the assessment asks participants to identify tasks that they find value in completing, rank their priority, and rank their ability to perform them.
3 secondary outcomes
Motor evoked potential status (MEPs)
Time frame: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation
Maximum Voluntary Contraction (MVC)
Time frame: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation
H-reflex
Time frame: Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background: PubMed 17077374Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Background: PubMed 15592988Barreca S, Gowland CK, Stratford P, Huijbregts M, Griffiths J, Torresin W, Dunkley M, Miller P, Masters L. Development of the Chedoke Arm and Hand Activity Inventory: theoretical constructs, item generation, and selection. Top Stroke Rehabil. 2004 Fall;11(4):31-42. doi: 10.1310/JU8P-UVK6-68VW-CF3W.
- Background: PubMed 31996455Benavides FD, Jo HJ, Lundell H, Edgerton VR, Gerasimenko Y, Perez MA. Cortical and Subcortical Effects of Transcutaneous Spinal Cord Stimulation in Humans with Tetraplegia. J Neurosci. 2020 Mar 25;40(13):2633-2643. doi: 10.1523/JNEUROSCI.2374-19.2020. Epub 2020 Jan 29.
- Background: PubMed 31609714Stoykov ME, King E, David FJ, Vatinno A, Fogg L, Corcos DM. Bilateral motor priming for post stroke upper extremity hemiparesis: A randomized pilot study. Restor Neurol Neurosci. 2020;38(1):11-22. doi: 10.3233/RNN-190943.
- Provides information about current treatment options for stroke patients and their efficacy in helping to restore function of the upper limbs.Link provided by the sponsor.
- This source describes the Fugl-Meyer evaluation method and how this method has been validated for evaluation of the upper limb.Link provided by the sponsor.
- This source provides information about the CAHAI evaluation method, specifically about the development of the measure and how the included tests were selected.Link provided by the sponsor.
- This source outlines a procedure to determine the presence of motor-evoked potentials (MEPs) by transcutaneous magnetic stimulation (TMS) in the upper extremity. This information was used to help us design our protocol.Link provided by the sponsor.
- This source provides further explanation of the procedure for eliciting motor evoked potentials (MEPs) in the upper extremities.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Neurophysiological and Behavioral Effects of Combining Transcranial Direct Current Stimulation (tDCS) and Modified-Constraint Induced Movement Therapy (mCIMT)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task Specific Training (TST) and Transcutaneous electrical spinal cord stimulation (TESS) in people with Upper Limb Hemiparesis Following Stroke, run by Shirley Ryan AbilityLab 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Ellen Stoykov, PhD, OT (773-704-2422, mstoykov@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Test of Upper Extremity Function (FMUE) (time frame: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation). The study lists 5 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 NCT06950593, which also lists 5 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 12 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.