Double Dose 4-AP on Functional Recovery After Spinal Cord Injury

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT06853015
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • SCI - Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dalfampridine — DRUG
    The study drug (4-AP) will be administered as a 10 mg dose twice a day.
  • Placebo — DRUG
    The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.
  • STDP stimulation — OTHER
    Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.
  • Exercise training — BEHAVIORAL
    Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.

Study Details

The purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (SCI). The FDA approved drug, Dalfampridine (4-AP). 4-AP will be used twice-daily in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Key Dates

Start date
Feb 1, 2025
Status verified
Jun 2026
Primary completion
Mar 1, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4-AP(AM) + STDP stimulation + training + 4-AP(PM)
    The effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of twice-daily-dosing 4-AP, STDP stimulation and training.
  • Placebo Comparator: Placebo(AM) + STDP stimulation + training + Placebo(PM)
    The effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of twice-daily-dosing Placebo, STDP stimulation and training.

Primary Outcome Measure

Change in TMEPs [ Time Frame: TMEPs measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilitylabChicagoIllinois60611
Monica Perez, PT, PhD
[email protected]
312-238-2886

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Shirley Ryan Abilitylab· Chicago, IL

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