Double Dose 4-AP on Functional Recovery After Spinal Cord Injury
NCT ID: NCT06853015
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2025-02-01
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Dalfampridine
The study drug (4-AP) will be administered as a 10 mg dose twice a day.
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.
Exercise training
Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.
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.
Placebo
The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.
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.
Exercise training
Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.
Interventions
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Dalfampridine
The study drug (4-AP) will be administered as a 10 mg dose twice a day.
Placebo
The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.
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.
Exercise training
Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Shirley Ryan AbilityLab
OTHER
Responsible Party
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Monica Perez
Scientific Chair
Principal Investigators
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Monica Perez, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan Ability Lab
Locations
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Shirley Ryan Abilitylab
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00221545
Identifier Type: -
Identifier Source: org_study_id
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