← 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
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
Male or female between 18 and 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every 5-10 minutes, for up to 4 hours. change will be compared to baseline.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can move my fingers or do a thumb-index finger pinch.
Select...
I am between 18 and 65 years old.
Select...
My hand muscles respond to stimulation tests.
Select...
My medication and rehabilitation plan have been stable for over a month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured every 5-10 minutes, for up to 4 hours. change will be compared to baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured every 5-10 minutes, for up to 4 hours. change will be compared to baseline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Assessing cortical plasticity
Assessing corticospinal plasticity
Assessing spinal plasticity
+9 more

Trial 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
20 Previous Clinical Trials
1,258 Total Patients Enrolled
Lynda M Murray, PhDPrincipal InvestigatorBronx VA Medical Center / James J. Peters Veterans Affairs Medical Center

Media Library

Atomoxetine (Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05708274 — Phase 1
Spinal Cord Injury Research Study Groups: CD-LD + hand training, Placebo + hand training, CPH + hand training, ATX + hand training
Spinal Cord Injury Clinical Trial 2023: Atomoxetine Highlights & Side Effects. Trial Name: NCT05708274 — Phase 1
Atomoxetine (Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708274 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree of risk is CPH + hand training associated with?

"According to our team at Power, CPH + hand training has only limited clinical data backing its safety and efficacy; thus it earned a score of 1."

Answered by AI

Are adults over the age of 35 eligible to participate in this clinical trial?

"The research criteria for this medical trial stipulates that patients must be between eighteen and sixty-five years of age. There are 136 clinical trials available to minors and 714 studies accessible to the elderly population."

Answered by AI

Are any individuals being sought for participation in this research endeavor?

"Affirmative. According to information available on clinicaltrials.gov, this trial is currently enrolling patients, which began after its initial posting on January 20th of 2021 and was recently updated on the 23rd of that same month. 28 individuals are required for participation across a single medical centre."

Answered by AI

How many individuals are under evaluation in this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that the trial, published on January 20th of this year, is still looking for participants. 28 individuals need to be enlisted from a single medical site."

Answered by AI

Am I eligible to be a participant in this research project?

"This clinical trial is seeking 28 participants ranging in the ages of 18 to 65 with spinal cord injury. To be eligible, patients must satisfy further criteria: they should either identify as male or female; possess a degree of motor impairment (2/5) on manual muscle testing for finger extension, flexion and abduction or demonstrate capacity for thumb-index pinch; display detectable stimulation-evoked responses from FDI and APB muscles as well as EMG activity during pinch movement; maintain steady medication dosage (> 30 days prior) and participation in rehabilitation regimens (> 15 days). Additionally, those recruited are required to abstain from alcohol, smoking,"

Answered by AI
~6 spots leftby Jul 2024