Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI

A vizsgálat adatai

Ki végzi

TryAbility LLC

Azonosító

NCT07922122

A regiszteradat frissítve

2026. november 6.

Eredeti leírás

The purpose of this prospective, single-arm pilot feasibility study is to evaluate the safety, feasibility, and preliminary functional outcomes of combining transcutaneous spinal cord stimulation (TSS), dalfampridine (4-aminopyridine), and intensive rehabilitation in adults with chronic spinal cord injury (SCI).A teljes eredeti leírásKevesebb

Combination Therapy: Transcutaneous Spinal Stimulation (TSS), 4 Aminopyridine (4 AP), and Intensive Rehabilitation for Motor Recovery After Spinal Cord Injury

The purpose of this prospective, single-arm pilot feasibility study is to evaluate the safety, feasibility, and preliminary functional outcomes of combining transcutaneous spinal cord stimulation (TSS), dalfampridine (4-aminopyridine), and intensive rehabilitation in adults with chronic spinal cord injury (SCI).

The primary research question is whether this combined treatment approach can be safely and feasibly implemented in an outpatient neurorehabilitation setting. The study will also explore whether participants demonstrate improvements in upper and lower extremity motor function, muscle strength, walking ability, balance, and functional mobility following the intervention.

Eight adults with chronic spinal cord injury will participate in a 12-week rehabilitation program at TRYAbility NeuroRecovery Center. Participants will attend approximately three treatment sessions per week, consisting of 60 minutes of physical therapy and 60 minutes of occupational therapy combined with noninvasive transcutaneous spinal cord stimulation using the ANEUVO ExaStim Stimulation System. All participants will be receiving dalfampridine prescribed by their treating physicians as part of routine medical care. The research team will not prescribe, administer, or adjust medication dosages.

The primary outcomes will focus on participant recruitment, treatment attendance, intervention tolerability, and adverse events to assess the feasibility and safety of the combined approach. Secondary exploratory outcomes will examine changes in upper extremity motor function, hand dexterity, walking speed, walking endurance, balance, and functional mobility.

Participants will undergo standardized clinical assessments at baseline, week 6, and week 12 to evaluate changes in functional performance over time.

The findings will provide preliminary evidence regarding the feasibility, safety, and potential functional benefits of integrating spinal cord stimulation, physician-prescribed dalfampridine, and intensive rehabilitation. Results will help inform the design of larger controlled clinical trials investigating combined treatment approaches for motor recovery following chronic spinal cord injury.

Kizáró feltételek: History of uncontrolled seizure disorder; Contraindication to 4-aminopyridine (dalfampridine); Uncontrolled cardiovascular disease; Presence of implanted electrical medical devices, including pacemakers or neurostimulators; Pregnancy; Severe pressure injuries that prevent safe electrode placement; Known or suspected significant cognitive impairment, dementia, intellectual disability, or other neurological or psychiatric conditions that interfere with comprehension of study requirements or the ability to complete study assessments.

Inclusion Adults between 18 and 75 years of age; Diagnosis of chronic spinal cord injury (SCI), at least 12 months post-injury; Medically stable and able to participate in intensive rehabilitation therapy; Able to provide informed consent; Currently receiving 4-aminopyridine (dalfampridine) prescribed by their treating physician as part of routine medical care. Criteria:; -.

ClinicalTrials.gov NCT07922122