Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm pilot study will enroll eight adults with chronic spinal cord injury (at least 12 months post-injury) to receive a 12-week outpatient program combining transcutaneous spinal cord stimulation, dalfampridine, and intensive physical and occupational therapy. The objective is to assess safety and feasibility of the combined approach in a real-world rehabilitation setting and to explore preliminary changes in upper and lower extremity motor function, strength, ambulation, balance, and functional mobility. Participants will undergo about three treatment sessions per week, each session including 60 minutes of physical therapy and 60 minutes of occupational therapy, alongside ongoing dalfampridine as prescribed by their treating physician. The study builds on the rationale that neuromodulation and pharmacologic augmentation may enhance activity-dependent neuroplasticity when paired with task-specific rehabilitation. Outcomes from this pilot will inform whether this multimodal strategy merits further investigation in larger, controlled trials.

Why it matters

Who can join: the full rules

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:

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Exclusion Criteria:

* 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.

Where it's running

• TryAbility Neuro Recovery Center
  Downers Grove, Illinois, United States Recruiting

Study contacts

• Principal investigator: Sakina Valika, DPT — TryAbility NeuroRecovery Centr
• Study coordinator: Sakina Valika, DPT
• Email: sakina@tryabilityrehab.com
• Phone: 331-775-2813

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.