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

A vizsgálat adatai

Ki végzi

Casa Colina Hospital and Centers for Healthcare

Azonosító

NCT07917221

A regiszteradat frissítve

2026. november 4.

Eredeti leírás

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:A teljes eredeti leírásKevesebb

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

Bevonási feltételek: 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.

Kizáró feltételek: 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; Index stroke is hemorrhagic or involves the brainstem, cerebellum, or thalamus, as confirmed by neuroimaging or medical records; Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds, unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction; Allergy to hydrogel, silicone, latex or other product materials; Uncontrolled cardiopulmonary disease or hypertension; Other symptoms that would prohibit use or cause discomfort from stimulation such as hypersensitivity; History of more than one stroke episode; History of uncontrolled epilepsy or seizures; Unmanaged depression, psychiatric disorders or ongoing substance abuse; Active implanted medical device for electrical stimulation; 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; BMI > 40.0 (morbid obesity); Subjects who are pregnant or planned pregnancy during the study. Participants of childbearing potential must agree to effective contraception for the duration of participation; Compromised skin in the area for electrode contact (back of neck and/or hip area); 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; Severe contractures of upper extremity(s); Severe receptive and/or expressive aphasia limiting communication and understanding of device and interventions; Participation in another clinical trial that may interfere with this study.

ClinicalTrials.gov NCT07917221