Can common drugs boost hand recovery after spinal cord injury?
NCT ID NCT05708274
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 trial tested whether three FDA-approved drugs (cyproheptadine, carbidopa-levodopa, and atomoxetine) could improve hand function when combined with hand training exercises in 25 people with chronic spinal cord injury. Participants took a single dose of one drug or a placebo, then performed hand tasks. The study measured dexterity, grip strength, and nerve signals to see if the drugs help strengthen brain-spinal cord connections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cyproheptadine, carbidopa-levodopa, and atomoxetine
- What this could lead to
- If successful, this could point toward a drug-assisted therapy to improve hand strength and dexterity after spinal cord injury.
- What could go wrong
- This is a small, early-phase trial with only 25 participants and single doses, so results may not apply widely or lead to a lasting treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Oct 2025
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female between 18 and 65 years of age; clinically stable chronic (\> 12 months) SCI at or above C8 spinal segment; * Motor-incomplete with a score of 2 or more (out of 5) on manual muscle testing (MMT) of finger extension, finger flexion, or finger abduction in left or right hand(s); or able to perform thumb-index finger pinch of the left or right hand; * Detectable stimulation-evoked muscle responses of the left or right first dorsal interosseous (FDI) and/or abductor pollicis brevis (APB); Detectable FDI/APB surface electromyography (EMG) muscle activity during thumb-index finger pinch; * Must have stable: medication \[≥ 30 days prior\]; rehabilitation regimen \[≥ 15 days prior\]; * Must be able to: abstain from alcohol, smoking and caffeine consumption on the day prior/of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 7 visits); provide informed consent. Exclusion Criteria: * History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging); * History of other serious central or peripheral neurological injury; * History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain stimulation or task performance; * Ventilator dependence or patent tracheostomy site; * Unstable syrinx, or multiple spinal cord lesions; * Unclear diagnosis; History of stroke, brain tumor, brain abscess, or multiple sclerosis; * Personal history of seizures; extensive family history of seizures; use of medications that lower seizure threshold (e.g., amphetamines, dalfampridine, and bupropion); * Use of the study medications; Use of medications known to have significant adverse interactions with the study medication as described in the manufacturers' prescribing information \[14 days prior\]; previous allergic reaction or hypersensitivity to study drug(s); * Presence of a medical condition that represents a risk for study drug(s) administration; evidence of liver disease or clinical jaundice; neutropenia; glaucoma; gastrointestinal ulcer(s); active malignancy; undiagnosed skin lesions; autoimmune disorders; chronic infectious diseases (e.g. HIV, hepatitis B or C); pregnancy or nursing mothers (a pregnancy urine test may be warranted); neurologic disorders (including a history of serious head trauma or seizures), and uncontrolled cardiovascular, metabolic, pulmonary or renal disease; premorbid, ongoing major depression or psychosis, altered cognitive status; bipolar disorder; suicidal ideation or past suicide attempts; * History of severe hearing problems, loss or tinnitus; * Presence of urinary infection, fever, pressure ulcer; or open skin lesions (shoulders or arms); * Recent history (\< 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in HR, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (closely monitored during all testing procedures); * Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous 48 hours; * Recent history (\>1 year) of chemical substance dependency or significant psychosocial disturbance; * Study participation of an investigational drug or device \[60 days prior\]; * Unsuitable for study participation as determined by the study physician.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468, United States
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Other studies related to the condition(s) this trial covers.
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