Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke (EXA2611)

October 29, 2026 updated by: Casa Colina Hospital and Centers for Healthcare

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?

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Pomona, California, United States, 91767
        • Casa Colina Hospital and Centers for Healthcare
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Emily Rosario, PhD
        • Principal Investigator:
          • Yannick Darmon, PT, PhD
        • Sub-Investigator:
          • Daniel Humphrey, PT, DPT, NCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must have a documented diagnosis of a singular unilateral ischemic stroke event confirmed by radiology report.
  2. Participant is in the chronic stage of neurological recovery, defined as at least 6 months after the unilateral ischemic stroke event.
  3. Subject is aged 18-75 years
  4. 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)
  5. Subject must have a Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score between 20 and 50 (inclusive) at screening.
  6. 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
  7. 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.
  8. 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.

Exclusion Criteria:

  1. Active implanted medical device for electrical stimulation
  2. Index stroke is hemorrhagic or involves the brainstem, cerebellum, or thalamus, as confirmed by neuroimaging or medical records.
  3. Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
  4. Botox injections to the upper limb(s) in prior 3 months
  5. 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.
  6. Subject scores <20 or >50 points on the FMA-UE.
  7. BMI > 40.0 (morbid obesity)
  8. Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds, unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
  9. Subjects who are pregnant or planned pregnancy during the study. Participants of childbearing potential must agree to effective contraception for the duration of participation.
  10. Allergy to hydrogel, silicone, latex or other product materials
  11. Compromised skin in the area for electrode contact (back of neck and/or hip area)
  12. Uncontrolled cardiopulmonary disease or hypertension
  13. Presence of ongoing dysphagia or aspiration difficulties.
  14. 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.
  15. Other symptoms that would prohibit use or cause discomfort from stimulation such as hypersensitivity.
  16. History of more than one stroke episode
  17. Severe contractures of upper extremity(s)
  18. Severe receptive and/or expressive aphasia limiting communication and understanding of device and interventions
  19. History of uncontrolled epilepsy or seizures
  20. Unmanaged depression, psychiatric disorders or ongoing substance abuse
  21. Participation in another clinical trial that may interfere with this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANEUVO ExaStim Stimulation System
Device: Transcutaneous Spinal Stimulation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test (ARAT)
Time Frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17

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.
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

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.
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

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.
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

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.
Initial assessment at enrollment, at the end of each treatment session, and during re-assessment visits at weeks 4, 8, and 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Activity Log (MAL)
Time Frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17

The Motor Activity Log (MAL) is a structured, semi-structured clinical interview where stroke survivors rate their actual daily arm use in terms of Amount of Use (AOU) and How Well (HW) they perform 30 real-world functional tasks. Each item is scored on a 0-to-5 ordinal scale, ranging from 0 (not used at all) to 5 (used as well as before the stroke), with final scores derived from the average of all items. A change in score exceeding the minimal clinically important difference (typically around 1.0 to 1.1 points for either subscale) indicates a meaningful, real-world translation of laboratory motor gains into spontaneous, daily spontaneous arm use.
Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
Stroke Impact Scale (SIS)
Time Frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17

The Stroke Impact Scale (SIS) is a patient-reported outcome measure evaluating health-related quality of life across eight domains, including strength, hand function, ADLs, mobility, communication, emotion, memory, and participation. Each item is scored on a 1-to-5 ordinal scale, which is then transformed into a standardized 0-to-100 scale per domain, where higher scores reflect better recovery and fewer stroke-related limitations. A score change exceeding the minimal clinically important difference (typically ranging from about 3 to 17 points depending on the specific domain) indicates a statistically reliable and meaningful improvement in the patient's perceived recovery and daily well-being.
Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
Modified Ashworth Scale (MAS)
Time Frame: Initial assessment at enrollment, re-assessment at week 12

Modified Ashworth Scale (MAS), it grades spasticity and muscle hypertonia on a 6-point ordinal scale from 0 (no increase in tone) to 4 (rigid limb in flexion or extension). A decrease in score indicates a reduction in passive resistance and muscle hypertonia, reflecting successful management of spasticity.
Initial assessment at enrollment, re-assessment at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa Colina Hospital and Centers for Healthcare

Collaborators

Niche Biomedical, Inc. dba ANEUVO

Investigators

  • Study Director: Emily Rosario, PhD, Casa Colina Hospital and Centers for Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 18, 2026

Primary Completion (Estimated)

May 18, 2027

Study Completion (Estimated)

November 18, 2027

Study Registration Dates

First Submitted

October 29, 2026

First Submitted That Met QC Criteria

October 29, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

October 29, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StrokeTSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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