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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UNKNOWN
EARLY_PHASE1
44 participants
INTERVENTIONAL
2022-06-30
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Dalfampridine (4-AP)+STDP+training
The effects of the functional recovery of the lower-limb muscles will be determined after 10 sessions of 4-AP, STDP stimulation and training.
Dalfampridine
The study drug (4-AP) will be administered as a 10 mg dose.
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+STDP+training
The effects of the functional recovery of the lower-limb muscles will be determined after 10 sessions of placebo drug, STDP stimulation and training.
Placebo drug
The pharmacy will also provide a placebo drug that looks identical to 4-AP to verify participants and therapists do not know who is receiving the drug and who is receiving the placebo.
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.
Dalfampridine (4-AP)+STDP+training for extended sessions
The long-term effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of 4-AP, STDP stimulation and training.
Dalfampridine
The study drug (4-AP) will be administered as a 10 mg dose.
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.
Placebo drug
The pharmacy will also provide a placebo drug that looks identical to 4-AP to verify participants and therapists do not know who is receiving the drug and who is receiving the placebo.
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 at least 4 weeks post injury
* Spinal Cord injury at or above L2
* ASIA A,B,C, or D, complete or incomplete
* Possess the following abilities
* 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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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Monica Perez
Chair, Arms and Hands
Principal Investigators
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Monica A 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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Other Identifiers
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STU00215984
Identifier Type: -
Identifier Source: org_study_id
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