Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Public ClinicalTrials.gov record NCT07922122. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Combination Therapy: Transcutaneous Spinal Stimulation (TSS), 4 Aminopyridine (4 AP), and Intensive Rehabilitation for Motor Recovery After Spinal Cord Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07922122
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 8 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 6, 2026 (Actual)
- Primary completion
- Jul 8, 2027 (Estimated)
- Completion
- Sep 8, 2027 (Estimated)
- Last update posted
- Nov 6, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| TryAbility Neuro Recovery Center | Downers Grove | Illinois | 60515 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07922122, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2026 · Synced Nov 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07922122 live on ClinicalTrials.gov.