TSS, Dalfampridine, RehabilitationTranscutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI

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.