An interventional study of Transcutaneous Spinal Stimulation in Chronic Stroke, Ischemic Stroke and CVA (Cerebrovascular Accident), sponsored by Casa Colina Hospital and Centers for Healthcare. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Casa Colina Hospital and Centers for Healthcare · Not applicable, Interventional, and Device feasibility
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:
Participants will:
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:
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.
2,679 studies on the registry are indexed under Ischemic Stroke; 959 are open to participants now.
This study's planned enrollment of 5 is below the median of 120 across 1,818 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Casa Colina Hospital and Centers for Healthcare is the lead sponsor of 13 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
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.
Time frame: 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.
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)
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.
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
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.
Time frame: Initial assessment at enrollment, at the end of each treatment session, and during re-assessment visits at weeks 4, 8, and 12
Motor Activity Log (MAL)
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.
Time frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
Stroke Impact Scale (SIS)
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.
Time frame: Initial assessment at enrollment, re-assessment at weeks 4, 8, 12, and 17
Modified Ashworth Scale (MAS)
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.
Time frame: Initial assessment at enrollment, re-assessment at week 12
Plan to share: No
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Casa Colina Hospital and Centers for Healthcare