Double Dose 4-AP on Functional Recovery After Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dalfampridine, Placebo, STDP stimulation, Exercise training.
- Who it may be relevant to
- Registry conditions: SCI - Spinal Cord Injury. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Twice-daily Dosing 4-AP on Functional Recovery After Spinal Cord Injury
Overview
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.
Detailed description
Currently, research has shown that 4-AP has a positive effect on sensory and motor function rehabilitation in humans with chronic SCI in addition to decreasing recorded spasticity, increased sensation, and decreased pain. A pharmacokinetic study showed that twice-daily administration of sustained release 4-AP maintains a steadier plasma concentration. Utilizing limb training to promote recovery of motor function is enhanced by eliciting STDP in the limbs. An important strength of this aim is the combination of training and STDP, which aims to enhance the beneficial effects of motor training by promoting plasticity in the corticospinal pathway. Training effects on physiological pathways will be explored and correlated with lower limb motor function. We hypothesize that introducing 4-AP into the STDP stimulation and STDP stimulation with training will further improve motor function rehabilitation in patients with chronic SCI.
Interventions
- Drug Dalfampridine
The study drug (4-AP) will be administered as a 10 mg dose twice a day. - Drug Placebo
The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day. - Other STDP stimulation
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. - Behavioral Exercise training
Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.
Primary outcome measures
- Change in TMEPs [Time frame: TMEPs measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).]
- Change in MVC [Time frame: MVC measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).]
Secondary outcome measures (6)
- Change in 10-meter walk test [Time frame: 10-m walk measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).]
- Change in 6-minute walk test [Time frame: 6-min walk measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).]
- Change in International Standards for Neurological Classification of Spinal Cord Injury exam [Time frame: Scores measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).]
- Change in EPT [Time frame: EPT will be measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).]
- Change in surveys on ambulation, basic mobility, bowel and bladder management difficulties [Time frame: SCI-QOL measured at at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).]
- Change in morphological characterization of corticospinal and reticulospinal pathways in MRI [Time frame: MRI measured at baseline, and at 12 weeks (post 40 sessions).]
Eligibility criteria
Inclusion criteria
- 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
- The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles
Exclusion criteria
- 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
- History of head injury or stroke
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
- History of seizures or epilepsy
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2)
- Pregnant females
- If a women of child bearing age is unsure of the pregnancy, and does not want to take the pregnancy test
- Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk
- Metal plate in skull
- Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
- Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Shirley Ryan Abilitylab — Chicago
Identifiers
NCT: NCT06853015 · STU00221545