Chronic StrokeEXA2611NCT07917221
Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
A study testing Transcutaneous Spinal Stimulation in people with Chronic Stroke and Ischemic Stroke, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the safety, tolerability, and feasibility of ExaStim transcutaneous electrical stimulation combined with task-specific rehabilitation, and to characterize changes in arm function in adults with chronic unilateral ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Stroke, Ischemic Stroke, CVA (Cerebrovascular Accident)
- What is being tested?
- Transcutaneous Spinal Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2026to 18 Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have a documented diagnosis of a singular unilateral ischemic stroke event confirmed by radiology report.
- Participant is in the chronic stage of neurological recovery, defined as at least 6 months after the unilateral ischemic stroke event.
- Subject is aged 18-75 years
- In the investigators or qualified clinician's judgment, the subject must possess sufficient global cognitive capacity to understand and follow study-related instructions, actively participate in task-specific rehabilitation, and provide informed consent. Cognitive capacity will be supported by the subject's ability to follow a three-step command and demonstrate orientation to person, place, time, and situation (4/4)
- Subject must have a Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score between 20 and 50 (inclusive) at screening.
- Subject must be able to commit to participating in a 17-week study, and be willing to comply with study instructions, agree to make all office and therapy appointments, and complete the entire course of the study
- Subject must be deemed medically stable for intensive physical rehabilitation and transcutaneous electrical stimulation, supported by formal written clearance from their primary care physician or managing neurologist.
- Subject must be able to understand the study, provide informed consent, and complete the applicable HIPAA authorization using IRB-approved procedures. Literacy alone is not an exclusion. IRB-approved accessible consent methods may be used when needed, while the investigator confirms the participant's own understanding, decision-making capacity, and ability to meet study communication requirements.
Who cannot join
- Active implanted medical device for electrical stimulation
- Index stroke is hemorrhagic or involves the brainstem, cerebellum, or thalamus, as confirmed by neuroimaging or medical records.
- Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
- Botox injections to the upper limb(s) in prior 3 months
- Severe spasticity, MAS grade >3 (grade 4 only; grade 3 is not excluded by this criterion) in any of the following muscles: shoulder abductors, shoulder flexors, elbow flexors/extensors, wrist flexion, forearm supination or pronation, or finger flexors.
- Subject scores <20 or >50 points on the FMA-UE.
Show all 21Show fewer
- BMI > 40.0 (morbid obesity)
- Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds, unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
- Subjects who are pregnant or planned pregnancy during the study. Participants of childbearing potential must agree to effective contraception for the duration of participation.
- Allergy to hydrogel, silicone, latex or other product materials
- Compromised skin in the area for electrode contact (back of neck and/or hip area)
- Uncontrolled cardiopulmonary disease or hypertension
- Presence of ongoing dysphagia or aspiration difficulties.
- Significant sensory impairments. Subjects who score below a 6 out of 12 on the sensory subscale (section H) of the Fugl Meyer Assessment will be excluded.
- Other symptoms that would prohibit use or cause discomfort from stimulation such as hypersensitivity.
- History of more than one stroke episode
- Severe contractures of upper extremity(s)
- Severe receptive and/or expressive aphasia limiting communication and understanding of device and interventions
- History of uncontrolled epilepsy or seizures
- Unmanaged depression, psychiatric disorders or ongoing substance abuse
- Participation in another clinical trial that may interfere with this study
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
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767
Emily Rosario, PhD, 609-596-7733 ext. 3036, erosario@casacolina.org
Daniel Humphrey, PT, DPT, NCS, 609-596-7733 ext. 3036, dhumphrey@casacolina.org
About this study
Official title: Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Chronic Stroke Population
The goal of this clinical trial is to learn about the safety, tolerability, and feasibility of ExaStim transcutaneous electrical stimulation combined with task-specific rehabilitation, and to characterize changes in arm function in adults with chronic unilateral ischemic stroke. The main questions it aims to answer are:
- Does 12 weeks of ExaStim stimulation combined with structured, task-specific rehabilitation improve arm function?
- What are the safety, tolerability, and feasibility of ExaStim use in individuals with chronic stroke?
Read more
Participants will:
- Complete a 12-week intervention period combining ExaStim transcutaneous electrical stimulation with structured, task-specific rehabilitation
- Undergo clinical assessments and outcome testing baseline, week 4, week 8, week 12, and week 17 (follow-up)
- Monitor and report pain and quality of life via Visual Analog Scales (VAS) and questionnaires throughout the 17-week study duration
Read the detailed description
Primary exploratory clinical objective: To characterize change in upper extremity motor impairment following 12 weeks of ExaStim stimulation combined with structured, task-specific rehabilitation in individuals with chronic stroke.
Secondary objective: To characterize safety, tolerability, and feasibility of ExaStim use in individuals with chronic stroke. Exploratory objectives include describing immediate on/off-stimulation differences in dexterity and persistence of observed changes at Week 17; the design is not intended to establish causal effectiveness.
Additional exploratory outcomes:
- Change from baseline to Weeks 4, 8, and 17 in each of FMA-UE, ARAT, BBT, 9HPT, MAL, and SIS.
- Change from Week 12 to Week 17 in each of FMA-UE, ARAT, BBT, 9HPT, MAL, and SIS.
- Descriptive comparison of the group mean FMA-UE change from baseline to Week 12 with the exploratory 4.25-point reference.
- Change from baseline to Week 12 in Modified Ashworth Scale scores.
The FMA-UE screening range of 20-50 is supported by its use in chronic stroke neuromodulation studies, including VNS-REHAB (Dawson et al., 2021) and the TRICEPS protocol (Baig et al., 2025). This eligibility precedent does not establish a clinically meaningful change threshold for ExaStim. Page, Fulk, and Boyne (2012) reported clinically important differences of 4.25-7.25 points in chronic stroke with mild-to-moderate impairment, depending szon the therapist-rated anchor. Accordingly, 4.25 points will be used only as an exploratory reference when describing observed changes. Group mean change will summarize the overall magnitude of change, while individual changes and baseline scores will show participant variability. Neither a group mean nor an individual change of ≥4.25 points will define study success or a clinically meaningful responder in this proof-of-concept study.
Feasibility will be summarized using screening and enrollment counts, retention through Week 17, completed sessions out of 24 planned, sessions delivering at least 45 minutes of stimulated rehabilitation, actual stimulation minutes, interruptions, and reasons for missed visits or discontinuation. Twice-weekly paired BBT and 9HPT measurements will describe unstimulated trajectories and within-visit changes with stimulation. These summaries supplement the synopsis endpoints without changing their hierarchy. Feasibility measures will be reported descriptively with their denominators; no additional operational success thresholds are specified for this proof-of-concept study.
- Being tested
- Transcutaneous Spinal Stimulation
- Keywords
- transcutaneous spinal stimulation, upper extremity motor recovery, electrical stimulation, stroke recovery
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal StimulationDevice
Week 0 includes one baseline assessment session and two to three parameter optimization sessions. Participants will attend 2 rehabilitation sessions per week for 12 weeks, for a total of 24 sessions. Each session will provide ~60 minutes of rehabilitation, including at least 45 minutes of active stimulation delivered concurrently with therapeutic activity. The therapist will select activities according to participant goals, affected-arm capacity, movement quality, fatigue, pain, and cardiovascular tolerance. Each session will emphasize repeated practice, functional strength or functional practice. Missed sessions will be rescheduled within the 12-week period if appropriate.
Separate assessment visits occur in Weeks 4, 8, 12, and 17 and may last approximately one to two hours with rest breaks.
The final evaluation is scheduled for Week 17. All assessments will use the same participant-specific baseline date as the time reference, and actual visit dates and intervals will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| ANEUVO ExaStim Stimulation System | Experimental | Not described Receives: Device: Transcutaneous Spinal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity - Motor Score (FMA-UE)
The Fugl-Meyer Upper Extremity Assessment is a 66-point stroke-specific scale measuring sensorimotor recovery across reflexes, synergies, isolated movements, wrist stability, hand function, and coordination. Each item is scored from 0 to 2 based on performance completeness and compensation. Changes exceeding the minimal clinically important difference (typically 4 to 10 points) reflect meaningful gains in motor control and functional independence.
Measured: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
Secondary outcomes (4)
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 57-point, 19-item observational assessment measuring upper extremity functional capacity and dexterity across grasp, grip, pinch, and gross movement subscales. Each task is scored from 0 to 3 based on completion time, movement quality, and compensation patterns. A score change exceeding the minimal clinically important difference (typically 6 to 10 points) indicates meaningful improvement in real-world arm and hand function.
Measured: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
Box-and-Blocks Test (BBT)
The Box and Block Test measures unilateral gross manual dexterity by recording the number of one-inch wooden blocks a patient can transport over a partition from one compartment to another in 60 seconds. The scoring system simply counts the total number of successfully transferred blocks per hand, with multiple blocks carried simultaneously counting as a single point. An increase in score exceeding the minimal detectable change (typically around 6 or more blocks for stroke populations) indicates a true, statistically significant improvement in hand transport speed and unilateral functional capacity.
Measured: Initial assessment at enrollment, at the start of each treatment session, and during re-assessment visits at weeks 4, 8, 12, and 17
9-Hole Peg Test (9HPT)
The Nine-Hole Peg Test (9HPT) measures manual dexterity and finger-movement speed by recording the total seconds required for a patient to place and subsequently remove nine pegs into a board. Scoring is based on timing (seconds per trial), where lower times indicate better performance, or converted to "pegs per second" for rate-based analysis. A change in score exceeding the minimal detectable change (typically a reduction of several seconds or roughly 15 to 20% from baseline) indicates a statistically significant improvement in fine motor speed and coordination.
Measured: Initial assessment at enrollment, at the start of each treatment session, and during re-assessment visits at weeks 4, 8, 12, and 17
Visual Analog Scale (VAS) for pain
The Visual Analog Scale (VAS) measures subjective symptom intensity, such as pain, using a continuous horizontal line anchored by "no symptom" at one end and "worst imaginable symptom" at the other. Patients mark their perceived level, and the score is quantified from 0 to 10, where higher numbers reflect greater symptom severity. A score change exceeding a 2 point change indicates a clinically meaningful improvement or worsening of the patient's symptom experience.
Measured: Initial assessment at enrollment, at the end of each treatment session, and during re-assessment visits at weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start18 Nov 2026 (estimated)
- Primary completion18 May 2027 (estimated)
- Study completion18 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-facility, single-arm, prospective, interventional proof-of-concept study
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Niche Biomedical, Inc. dba ANEUVO
- Responsible party
- Sponsor
- Investigators
- Emily Rosario, PhD, Study director, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917221
- Sponsor's protocol ID
- StrokeTSS
- Acronym
- EXA2611
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zamurd, N., & Obaid Baig, M. (2022). The correlation between Fugl Meyer Upper Extremity Scale and Action Research Arm Test as a measure of upper extremity rehabilitation in stroke patients. Stroke Research and Therapy, 6(6), 153. https://doi.org/10.36648/IPSRT.22.6.6.153
Yao MC, Zhu SG, Yao CH. Gene amplification in Tetrahymena thermophila: formation of extrachromosomal palindromic genes coding for rRNA. Mol Cell Biol. 1985 Jun;5(6):1260-7. doi: 10.1128/mcb.5.6.1260-1267.1985.
PubMed 4033651Uchiyama Y, Takebayashi T, Takahashi K, Amano S, Gosho M, Sakai M, Hashimoto K, Hachisuka K, Domen K. Estimating the minimal clinically important difference of upper extremity outcome measures in chronic stroke patients with moderate to severe impairment: a cross-sectional study. Top Stroke Rehabil. 2024 May;31(4):409-417. doi: 10.1080/10749357.2023.2259649. Epub 2023 Sep 24.
PubMed 37742304Serlin RC, Mendoza TR, Nakamura Y, Edwards KR, Cleeland CS. When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain. 1995 May;61(2):277-284. doi: 10.1016/0304-3959(94)00178-H.
PubMed 7659438Sakamoto D, Hamaguchi T, Nakayama Y, Abo M. Reliability and validity of a newly developed Action Research Arm Test for upper limb function assessment in patients with stroke: A comparison with the conventional version. PLoS One. 2026 Mar 24;21(3):e0334199. doi: 10.1371/journal.pone.0334199. eCollection 2026.
PubMed 41875181Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20.
PubMed 36807682Park JH, Chang Y, Park S, Song TJ. Burden of stroke in the United States of America, 1990-2021: a systematic analysis for the US burden of disease study 2021. Front Neurol. 2025 Aug 14;16:1609508. doi: 10.3389/fneur.2025.1609508. eCollection 2025.
PubMed 40895113Page SJ, Fulk GD, Boyne P. Clinically important differences for the upper-extremity Fugl-Meyer Scale in people with minimal to moderate impairment due to chronic stroke. Phys Ther. 2012 Jun;92(6):791-8. doi: 10.2522/ptj.20110009. Epub 2012 Jan 26.
PubMed 22282773Oh J, Scheffler MS, Mahan EE, King ST, Martin CA, Dinh J, Steele AG, O'Malley MK, Sayenko DG. Combinatorial Effects of Transcutaneous Spinal Stimulation and Task-Specific Training to Enhance Hand Motor Output after Paralysis. Top Spinal Cord Inj Rehabil. 2023 Fall;29(Suppl):15-22. doi: 10.46292/sci23-00040S. Epub 2023 Nov 17.
PubMed 38174129Moshonkina TR, Zharova EN, Ananev SS, Shandybina ND, Vershinina EA, Lyakhovetskii VA, Grishin AA, Shlyakhto EV, Gerasimenko YP. A New Technology for Recovery of Locomotion in Patients after a Stroke. Dokl Biochem Biophys. 2022 Dec;507(1):353-356. doi: 10.1134/S1607672922340087. Epub 2023 Feb 14.
PubMed 36787001Moon Y, Zuleger T, Lamberti M, Bansal A, Mummidisetty CK, McKenzie KA, Yingling L, Madhavan S, Roth EJ, Lieber RL, Jayaraman A. Characterization of Motor-Evoked Responses Obtained with Transcutaneous Electrical Spinal Stimulation from the Lower-Limb Muscles after Stroke. Brain Sci. 2021 Feb 26;11(3):289. doi: 10.3390/brainsci11030289.
PubMed 33652677Moon Y, Yang C, Veit NC, McKenzie KA, Kim J, Aalla S, Yingling L, Buchler K, Hunt J, Jenz S, Shin SY, Kishta A, Edgerton VR, Gerasimenko YP, Roth EJ, Lieber RL, Jayaraman A. Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series. Biomed Eng Online. 2024 Apr 1;23(1):38. doi: 10.1186/s12938-024-01231-1.
PubMed 38561821Hays SA, Adehunoluwa EA, Epperson JD, Malley KM, Porter AL, Gallaway HL, Swank C, Carrera AJ, Stevens C, Gillespie J, Arnold D, Kian S, Bynum ZS, Meyers EC, Bleker N, Naftalis RC, Foreman ML, Hamilton RG, Rennaker RL, Kilgard MP, Wigginton JG. Closed-Loop Vagus Nerve Stimulation Delivered With a Miniaturized System Produces Lasting Recovery in Individuals With Chronic Stroke. Stroke. 2026 Jan;57(1):38-49. doi: 10.1161/STROKEAHA.125.052937. Epub 2025 Oct 7.
PubMed 41054846Flodin J, Mikkelsen C, Ackermann PW. Knee extensor force production and discomfort during neuromuscular electrical stimulation of quadriceps with and without gluteal muscle co-stimulation. Eur J Appl Physiol. 2022 Jun;122(6):1521-1530. doi: 10.1007/s00421-022-04949-9. Epub 2022 Apr 15.
PubMed 35426510Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
PubMed 33894832
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Chronic Stroke Population
- ClinicalTrials.gov ID
- NCT07917221
- Acronym / sponsor ID
- EXA2611 / StrokeTSS
- Keywords
- transcutaneous spinal stimulation, upper extremity motor recovery, electrical stimulation, stroke recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
- Collaborators
- Niche Biomedical, Inc. dba ANEUVO
- Study start
- 18 Nov 2026 (estimated)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 18 Nov 2027 (estimated)
- First posted
- 4 Nov 2026 (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 goal of this clinical trial is to learn about the safety, tolerability, and feasibility of ExaStim transcutaneous electrical stimulation combined with task-specific rehabilitation, and to characterize changes in arm function in adults with chronic unilateral ischemic stroke. The main questions it aims to answer are:
- Does 12 weeks of ExaStim stimulation combined with structured, task-specific rehabilitation improve arm function?
- What are the safety, tolerability, and feasibility of ExaStim use in individuals with chronic stroke?
Participants will:
- Complete a 12-week intervention period combining ExaStim transcutaneous electrical stimulation with structured, task-specific rehabilitation
- Undergo clinical assessments and outcome testing baseline, week 4, week 8, week 12, and week 17 (follow-up)
- Monitor and report pain and quality of life via Visual Analog Scales (VAS) and questionnaires throughout the 17-week study duration
Detailed description
Primary exploratory clinical objective: To characterize change in upper extremity motor impairment following 12 weeks of ExaStim stimulation combined with structured, task-specific rehabilitation in individuals with chronic stroke.
Secondary objective: To characterize safety, tolerability, and feasibility of ExaStim use in individuals with chronic stroke. Exploratory objectives include describing immediate on/off-stimulation differences in dexterity and persistence of observed changes at Week 17; the design is not intended to establish causal effectiveness.
Additional exploratory outcomes:
- Change from baseline to Weeks 4, 8, and 17 in each of FMA-UE, ARAT, BBT, 9HPT, MAL, and SIS.
- Change from Week 12 to Week 17 in each of FMA-UE, ARAT, BBT, 9HPT, MAL, and SIS.
- Descriptive comparison of the group mean FMA-UE change from baseline to Week 12 with the exploratory 4.25-point reference.
- Change from baseline to Week 12 in Modified Ashworth Scale scores.
The FMA-UE screening range of 20-50 is supported by its use in chronic stroke neuromodulation studies, including VNS-REHAB (Dawson et al., 2021) and the TRICEPS protocol (Baig et al., 2025). This eligibility precedent does not establish a clinically meaningful change threshold for ExaStim. Page, Fulk, and Boyne (2012) reported clinically important differences of 4.25-7.25 points in chronic stroke with mild-to-moderate impairment, depending szon the therapist-rated anchor. Accordingly, 4.25 points will be used only as an exploratory reference when describing observed changes. Group mean change will summarize the overall magnitude of change, while individual changes and baseline scores will show participant variability. Neither a group mean nor an individual change of ≥4.25 points will define study success or a clinically meaningful responder in this proof-of-concept study.
Feasibility will be summarized using screening and enrollment counts, retention through Week 17, completed sessions out of 24 planned, sessions delivering at least 45 minutes of stimulated rehabilitation, actual stimulation minutes, interruptions, and reasons for missed visits or discontinuation. Twice-weekly paired BBT and 9HPT measurements will describe unstimulated trajectories and within-visit changes with stimulation. These summaries supplement the synopsis endpoints without changing their hierarchy. Feasibility measures will be reported descriptively with their denominators; no additional operational success thresholds are specified for this proof-of-concept study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-facility, single-arm, prospective, interventional proof-of-concept study
| Arm | Type | Receives |
|---|---|---|
| ANEUVO ExaStim Stimulation System | Experimental | Device: Transcutaneous Spinal Stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must have a documented diagnosis of a singular unilateral ischemic stroke event confirmed by radiology report.
- Participant is in the chronic stage of neurological recovery, defined as at least 6 months after the unilateral ischemic stroke event.
- Subject is aged 18-75 years
- In the investigators or qualified clinician's judgment, the subject must possess sufficient global cognitive capacity to understand and follow study-related instructions, actively participate in task-specific rehabilitation, and provide informed consent. Cognitive capacity will be supported by the subject's ability to follow a three-step command and demonstrate orientation to person, place, time, and situation (4/4)
- Subject must have a Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score between 20 and 50 (inclusive) at screening.
Key exclusion criteria (21 listed)
- Active implanted medical device for electrical stimulation
- Index stroke is hemorrhagic or involves the brainstem, cerebellum, or thalamus, as confirmed by neuroimaging or medical records.
- Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
- Botox injections to the upper limb(s) in prior 3 months
- Severe spasticity, MAS grade >3 (grade 4 only; grade 3 is not excluded by this criterion) in any of the following muscles: shoulder abductors, shoulder flexors, elbow flexors/extensors, wrist flexion, forearm supination or pronation, or finger flexors.
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 |
|---|---|---|
| Transcutaneous Spinal StimulationWeek 0 includes one baseline assessment session and two to three parameter optimization sessions. Participants will attend 2 rehabilitation sessions per week for 12 weeks, for a total of 24 sessions. Each session will provide ~60 minutes of rehabilitation, including at least 45 minutes of active stimulation delivered concurrently with therapeutic activity. The therapist will select activities according to participant goals, affected-arm capacity, movement quality, fatigue, pain, and cardiovascular tolerance. Each session will emphasize repeated practice, functional strength or functional practice. Missed sessions will be rescheduled within the 12-week period if appropriate. Separate assessment visits occur in Weeks 4, 8, 12, and 17 and may last approximately one to two hours with rest breaks. The final evaluation is scheduled for Week 17. All assessments will use the same participant-specific baseline date as the time reference, and actual visit dates and intervals will be recorded. | Device | ANEUVO ExaStim Stimulation System |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity - Motor Score (FMA-UE)
Time frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
The Fugl-Meyer Upper Extremity Assessment is a 66-point stroke-specific scale measuring sensorimotor recovery across reflexes, synergies, isolated movements, wrist stability, hand function, and coordination. Each item is scored from 0 to 2 based on performance completeness and compensation. Changes exceeding the minimal clinically important difference (typically 4 to 10 points) reflect meaningful gains in motor control and functional independence.
4 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
Box-and-Blocks Test (BBT)
Time frame: Initial assessment at enrollment, at the start of each treatment session, and during re-assessment visits at weeks 4, 8, 12, and 17
9-Hole Peg Test (9HPT)
Time frame: Initial assessment at enrollment, at the start of each treatment session, and during re-assessment visits at weeks 4, 8, 12, and 17
Visual Analog Scale (VAS) for pain
Time frame: Initial assessment at enrollment, at the end of each treatment session, and during re-assessment visits at weeks 4, 8, and 12
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 4 Nov 2026.
- BackgroundZamurd, N., & Obaid Baig, M. (2022). The correlation between Fugl Meyer Upper Extremity Scale and Action Research Arm Test as a measure of upper extremity rehabilitation in stroke patients. Stroke Research and Therapy, 6(6), 153. https://doi.org/10.36648/IPSRT.22.6.6.153
- Background: PubMed 4033651Yao MC, Zhu SG, Yao CH. Gene amplification in Tetrahymena thermophila: formation of extrachromosomal palindromic genes coding for rRNA. Mol Cell Biol. 1985 Jun;5(6):1260-7. doi: 10.1128/mcb.5.6.1260-1267.1985.
- Background: PubMed 37742304Uchiyama Y, Takebayashi T, Takahashi K, Amano S, Gosho M, Sakai M, Hashimoto K, Hachisuka K, Domen K. Estimating the minimal clinically important difference of upper extremity outcome measures in chronic stroke patients with moderate to severe impairment: a cross-sectional study. Top Stroke Rehabil. 2024 May;31(4):409-417. doi: 10.1080/10749357.2023.2259649. Epub 2023 Sep 24.
- Background: PubMed 7659438Serlin RC, Mendoza TR, Nakamura Y, Edwards KR, Cleeland CS. When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain. 1995 May;61(2):277-284. doi: 10.1016/0304-3959(94)00178-H.
- Background: PubMed 41875181Sakamoto D, Hamaguchi T, Nakayama Y, Abo M. Reliability and validity of a newly developed Action Research Arm Test for upper limb function assessment in patients with stroke: A comparison with the conventional version. PLoS One. 2026 Mar 24;21(3):e0334199. doi: 10.1371/journal.pone.0334199. eCollection 2026.
- Background: PubMed 36807682Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20.
- Background: PubMed 40895113Park JH, Chang Y, Park S, Song TJ. Burden of stroke in the United States of America, 1990-2021: a systematic analysis for the US burden of disease study 2021. Front Neurol. 2025 Aug 14;16:1609508. doi: 10.3389/fneur.2025.1609508. eCollection 2025.
- Background: PubMed 22282773Page SJ, Fulk GD, Boyne P. Clinically important differences for the upper-extremity Fugl-Meyer Scale in people with minimal to moderate impairment due to chronic stroke. Phys Ther. 2012 Jun;92(6):791-8. doi: 10.2522/ptj.20110009. Epub 2012 Jan 26.
- Background: PubMed 38174129Oh J, Scheffler MS, Mahan EE, King ST, Martin CA, Dinh J, Steele AG, O'Malley MK, Sayenko DG. Combinatorial Effects of Transcutaneous Spinal Stimulation and Task-Specific Training to Enhance Hand Motor Output after Paralysis. Top Spinal Cord Inj Rehabil. 2023 Fall;29(Suppl):15-22. doi: 10.46292/sci23-00040S. Epub 2023 Nov 17.
- Background: PubMed 36787001Moshonkina TR, Zharova EN, Ananev SS, Shandybina ND, Vershinina EA, Lyakhovetskii VA, Grishin AA, Shlyakhto EV, Gerasimenko YP. A New Technology for Recovery of Locomotion in Patients after a Stroke. Dokl Biochem Biophys. 2022 Dec;507(1):353-356. doi: 10.1134/S1607672922340087. Epub 2023 Feb 14.
- Background: PubMed 33652677Moon Y, Zuleger T, Lamberti M, Bansal A, Mummidisetty CK, McKenzie KA, Yingling L, Madhavan S, Roth EJ, Lieber RL, Jayaraman A. Characterization of Motor-Evoked Responses Obtained with Transcutaneous Electrical Spinal Stimulation from the Lower-Limb Muscles after Stroke. Brain Sci. 2021 Feb 26;11(3):289. doi: 10.3390/brainsci11030289.
- Background: PubMed 38561821Moon Y, Yang C, Veit NC, McKenzie KA, Kim J, Aalla S, Yingling L, Buchler K, Hunt J, Jenz S, Shin SY, Kishta A, Edgerton VR, Gerasimenko YP, Roth EJ, Lieber RL, Jayaraman A. Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series. Biomed Eng Online. 2024 Apr 1;23(1):38. doi: 10.1186/s12938-024-01231-1.
- 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.
Emily Rosario, PhD study director
Casa Colina Hospital and Centers for Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Stimulation in people with Chronic Stroke and Ischemic Stroke, run by Casa Colina Hospital and Centers for Healthcare 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 21 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 Emily Rosario, PhD (609-596-7733 ext. 3036, erosario@casacolina.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for Upper Extremity - Motor Score (FMA-UE) (time frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17). 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 NCT07917221, which also lists 21 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 4 Nov 2026.