Actively Recruiting
Effects of Twice-Daily Dalfampridine (4-AP) on Functional Recovery After Spinal Cord Injury with STDP Stimulation and Limb Training
Led by Shirley Ryan AbilityLab · Updated on 2026-06-03
27
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating ways to improve lower limb motor function recovery in people with spinal cord injury (SCI). This study evaluates the effects of the FDA-approved drug Dalfampridine (4-AP) taken twice daily, combined with spike-timing-dependent plasticity (STDP) stimulation and limb training. The research focuses on whether adding 4-AP to STDP stimulation and training helps enhance motor function rehabilitation for those with chronic SCI. Participants will receive either twice-daily doses of 10 mg 4-AP or a matching placebo, along with STDP stimulation and lower-limb exercise training involving walking and stair climbing. The study involves 40 sessions of this combined treatment to assess functional recovery. The design includes two groups: one receiving 4-AP with STDP and training, and the other receiving placebo with STDP and training. During the study, researchers will measure changes in motor evoked potentials (TMEPs), maximal voluntary contraction (MVC), walking tests, neurological classification, sensory thresholds, and quality of life surveys at baseline, 6 weeks (after 20 sessions), and 12 weeks (after 40 sessions). MRI scans of motor pathways will be done at baseline and after 12 weeks. The study is randomized and triple-blinded, with participation lasting about 12 weeks.
CONDITIONS
Brief Title
Double Dose 4-AP on Functional Recovery After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 18 to 85 years
- Spinal cord injury at or above the L2 vertebra
- Injury occurred at least 6 months prior to enrollment
- ASIA impairment scale A, B, C, or D, complete or incomplete injury
- Ability to perform a small visible muscle contraction with foot dorsiflexion and hip flexor muscles
You will not qualify if you...
- Uncontrolled medical problems including lung, heart, or orthopedic disease
- History of kidney problems
- Debilitating disease before spinal cord injury causing exercise intolerance
- Major depression, psychosis, or altered cognitive status
- History of head injury or stroke
- Brain lesions from vascular, traumatic, tumoral, infectious, or metabolic causes
- History of seizures or epilepsy
- Use of drugs that lower seizure threshold
- Pregnancy or uncertain pregnancy status without testing
- Ongoing spinal cord compression, syrinx, or spinal cord diseases like spinal stenosis, spina bifida, multiple sclerosis, or herniated disk
- Presence of metal plate in skull
- Presence of scalp shrapnel, cochlear implants, or aneurysm clips
- Use of specific medications: Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or drugs prolonging PR interval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks (40 sessions)
Participants receive twice-daily doses of either 4-AP or placebo combined with STDP stimulation and lower-limb exercise training sessions to improve motor function after spinal cord injury.
40 sessions with twice-daily dosing and training visits
Trial Site Locations
Total: 1 location
1
Shirley Ryan Abilitylab
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
M
Monica Perez, PT, PhD
B
Bing Chen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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