Your session is about to expire
← Back to Search
Norepinephrine Reuptake Inhibitor
Drugs + Hand Training for Spinal Cord Injury
Phase 1
Recruiting
Led By Lynda M Murray, PhD
Research Sponsored by Bronx VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every 5-10 minutes, for up to 4 hours. change will be compared to baseline.
Summary
This trial is studying if drugs & hand training exercises can help strengthen brain-spinal cord connections after injury, with assessments of nerve transmission, muscle response, and motor performance.
Who is the study for?
This trial is for adults aged 18-65 with stable chronic spinal cord injury at or above C8, who have some hand muscle activity and are on a consistent medication and rehab plan. Participants must avoid alcohol, smoking, caffeine before visits, not use recreational drugs during the study, and commit to all sessions.
What is being tested?
The study tests if FDA-approved drugs (cyproheptadine, carbidopa-levodopa, atomoxetine) combined with hand exercises can improve brain-spinal cord connections in people with chronic spinal cord injuries. It measures nerve transmission and muscle response through noninvasive stimulation.
What are the potential side effects?
Potential side effects of the drugs may include drowsiness from cyproheptadine; nausea or low blood pressure from carbidopa-levodopa; increased heart rate or dry mouth from atomoxetine. Side effects vary by individual.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured every 5-10 minutes, for up to 4 hours. change will be compared to baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured every 5-10 minutes, for up to 4 hours. change will be compared to baseline.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessing task performance (dexterity)
Secondary study objectives
Assessing cortical plasticity
Assessing corticospinal plasticity
Assessing spinal plasticity
+8 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: CPH + hand trainingExperimental Treatment1 Intervention
A single dose of Cyproheptadine (CPH) (8 mg) will be administered. Supplied as 2 over-encapsulated pills of 4 mg each.
Group II: CD-LD + hand trainingExperimental Treatment1 Intervention
A single dose of IR Carbidopa-levodopa (CD-LD) (50/200 mg) will be administered. Supplied as 2 over-encapsulated pills (25 mg carbidopa / 100 mg levodopa each).
Group III: ATX + hand trainingExperimental Treatment1 Intervention
A single dose of Atomoxetine (ATX) (40 mg) will be administered. Supplied as 1 over-encapsulated pill of 40 mg plus 1 placebo capsule.
Group IV: Placebo + hand trainingPlacebo Group1 Intervention
A single dose of Placebo will be administered. Supplied as 2 gelatin capsules, identical in number, size, shape and color, filled with microcrystalline cellulose.
Find a Location
Who is running the clinical trial?
Bronx VA Medical CenterLead Sponsor
21 Previous Clinical Trials
1,318 Total Patients Enrolled
Lynda M Murray, PhDPrincipal InvestigatorBronx VA Medical Center / James J. Peters Veterans Affairs Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that could make the study drug unsafe for me.I rely on a ventilator to breathe or have an open tracheostomy.I have had repeated episodes of autonomic dysreflexia in the last 6 months.I do not have any implants or conditions that would interfere with brain stimulation.I am between 18 and 65 years old.I can move my fingers or do a thumb-index finger pinch.I do not have a urinary infection, fever, pressure ulcer, or open skin wounds on my shoulders or arms.I have never been diagnosed with a stroke, brain tumor, brain abscess, or multiple sclerosis.I have a history of seizures, a family history of seizures, or take medication that could increase my risk of seizures.My spinal cord injury above C8 has been stable for over a year.I have not had an allergic reaction to the study drug or taken any conflicting medications in the last 14 days.I have had a serious brain or nerve injury.My medication and rehabilitation plan have been stable for over a month.My hand muscles respond to stimulation tests.I have an unstable fluid-filled cyst in my spinal cord or multiple lesions.
Research Study Groups:
This trial has the following groups:- Group 1: CD-LD + hand training
- Group 2: Placebo + hand training
- Group 3: CPH + hand training
- Group 4: ATX + hand training
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.