Double Dose 4-AP on Functional Recovery After Spinal Cord Injury
ConditionSCI - Spinal Cord Injury
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShirley Ryan AbilityLab
About this trial
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.
Eligibility criteria
Qualifiers
Male and females between ages 18-85 years
SCI 6 months post injury
Spinal Cord injury at or above L2
ASIA A, B, C, or D, complete or incomplete
Disqualifiers
Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
Any history of renal impairment
Any debilitating disease prior to the SCI that caused exercise intolerance
Premorbid, ongoing major depression or psychosis, altered cognitive status
Trial design
Treatments tested in this trial
- Dalfampridine
- Placebo
- STDP stimulation
- Exercise training
Treatment groups
27 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov