TryAbility LLC
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.
Background and Rationale Spinal cord injury (SCI) can result in long-term impairments in voluntary motor control, muscle strength, mobility, balance, and functional independence. Although neurological recovery may be limited following chronic SCI, emerging research suggests that spinal neural networks below the level of injury may retain the capacity for functional activation through neuromodulation and activity-dependent rehabilitation. Transcutaneous spinal cord stimulation (TSS) is a noninvasive neuromodulation technique that delivers electrical stimulation through electrodes placed on th…
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: \- Exclusion Criteria: * History of uncontrolled seizure disorder. Contraindication to 4-aminopyridine (dalfampridine). Uncontrolled cardiovascular disease. Presence of implanted electrical medical devices, including…
The intervention consists of noninvasive transcutaneous spinal cord stimulation (TSS) delivered using the ANEUVO ExaStim Stimulation System in combination with intensive, task-specific physical and occupational therapy in adults with chronic spinal cord injury who are receiving physician-prescribed dalfampridine (4-aminopyridine). Stimulation will be delivered through surface electrodes positioned over the cervical (C5-C7) and thoracolumbar (T11-L1) spinal regions, with abdominal reference electrodes. The stimulation waveform will consist of biphasic rectangular pulses, with pulse widths ranging from 500 to 2000 microseconds and frequencies of 0-100 Hz. Stimulation intensity will be individualized to produce visible motor activation without discomfort. Participants will receive approximately three treatment visits per week for 12 weeks. Each visit will include 60 minutes of occupational therapy and 60 minutes of physical therapy, including device setup. Transcutaneous spinal stimulat