Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
NCT07917221, Not applicable, Not yet recruiting, Casa Colina Hospital and Centers for Healthcare
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke | ClinicalTrials.gov |
| NCT number | NCT07917221 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 5 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Casa Colina Hospital and Centers for Healthcare | ClinicalTrials.gov |
| Conditions | Chronic Stroke, Ischemic Stroke, CVA (Cerebrovascular Accident) | ClinicalTrials.gov |
| Interventions | Transcutaneous Spinal Stimulation | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Fugl-Meyer Assessment for Upper Extremity - Motor Score (FMA-UE) | 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. | ClinicalTrials.gov |
| Secondary | Action Research Arm Test (ARAT) | 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. | ClinicalTrials.gov |
| Secondary | Box-and-Blocks Test (BBT) | 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. | ClinicalTrials.gov |
| Secondary | 9-Hole Peg Test (9HPT) | 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. | ClinicalTrials.gov |
| Secondary | Visual Analog Scale (VAS) for pain | 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. | ClinicalTrials.gov |
| Other | Motor Activity Log (MAL) | 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. | ClinicalTrials.gov |
| Other | Stroke Impact Scale (SIS) | 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. | ClinicalTrials.gov |
| Other | Modified Ashworth Scale (MAS) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 20
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 4033651 | BACKGROUND | PubMed |
| 7659438 | BACKGROUND | PubMed |
| 22282773 | BACKGROUND | PubMed |
| 25239073 | BACKGROUND | PubMed |
| 33652677 | BACKGROUND | PubMed |
| 33840592 | BACKGROUND | PubMed |
| 33894832 | BACKGROUND | PubMed |
| 35426510 | BACKGROUND | PubMed |
| 35522473 | BACKGROUND | PubMed |
| 36787001 | BACKGROUND | PubMed |
| 36807682 | BACKGROUND | PubMed |
| 37742304 | BACKGROUND | PubMed |
| 38174129 | BACKGROUND | PubMed |
| 38561821 | BACKGROUND | PubMed |
| 40139703 | BACKGROUND | PubMed |
| 40895113 | BACKGROUND | PubMed |
| 41054846 | BACKGROUND | PubMed |
| 41094520 | BACKGROUND | PubMed |
| 41875181 | BACKGROUND | PubMed |
| 42287562 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)