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Spine stimulation, a medicine and intensive therapy for long-term spinal cord injury

Tests safety and practicality of combined treatment in adults with long-standing spinal cord injury.

Key facts

Who runs it
TryAbility LLC
Where
Downers Grove, United StatesSee the site
Trial code
Registry title
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Status
Recruiting
People taking part
8 people, planned
Started
6 Jun 2026
Expected to end
8 Sept 2027
Type of study
Interventional
Treatments tested
  • Transcutaneous spinal cord stimulation
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a long-lasting spinal cord injury who already take 4-aminopyridine (dalfampridine). They get skin-surface spinal stimulation plus intensive rehabilitation for 12 weeks.

Age
18 to 75 years
Sex
All sexes
Disease stage
Chronic spinal cord injury, at least 12 months after the injury. Medically stable and able to take part in intensive rehabilitation therapy.
Earlier treatment
Must currently take 4-aminopyridine (dalfampridine), prescribed by their own doctor as part of routine care.

Main reasons for not taking part

  • Seizure disorder that is not under control
  • Any reason you cannot take 4-aminopyridine (dalfampridine), or heart and blood vessel disease that is not under control
  • Implanted electrical devices, such as pacemakers or neurostimulators
  • Pregnancy
  • Severe pressure sores that prevent safe placement of electrodes, or serious problems with thinking or understanding that make it hard to follow the study

The registry criteria, word for word

Show all 7 criteriaShow less

Who cannot take part

  • 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

Other criteria

  • 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:
  • -

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

  • TryAbility Neuro Recovery CenterDowners Grove, United StatesContact: Arjun Kumar, OTDTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The group in the trial

  • Participants in this single-arm pilot feasibility study will undergo a 12-week intervention combininTreatment being tested

    Intervention Type Intervention Name Device ANEUVO ExaStim Transcutaneous Spinal Cord Stimulation Other Intensive Task-Specific Rehabilitation (Physical and Occupational Therapy)

    Treatment: Transcutaneous spinal cord stimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Combination Therapy: Transcutaneous Spinal Stimulation (TSS), 4 Aminopyridine (4 AP), and Intensive Rehabilitation for Motor Recovery After Spinal Cord Injury
Plain-language title
Spine stimulation, a medicine and intensive therapy for long-term spinal cord injuryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07922122, who can take part
Record updated
6 November 2026