Treatment for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Louisville, Kentucky Spinal Cord Injury Research Centre, Louisville, KY
Spinal Cord Injuries
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a combination of two supplements may help improve motor function for individuals with spinal cord injuries.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Spinal Cord Injuries

Study Objectives

This trial is evaluating whether Treatment will improve 5 primary outcomes and 7 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of 90-120minutes post drug-intake.

90-120min post drug-intake
Serum and Urine Analysis of dopamine
90-120minutes post drug-intake
Serum Analysis 5-HIAA
Serum Analysis 5-HT
Serum Catechloamines
Serum analysis Cortisol
Urine Homovanillic acid
Whole blood analysis 5-HT
Pre drug-intake, 120-150minutes post drug-intake
Change in movement performance
Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Change in corticospinal excitability
Change in motoneuron excitability
Change in spasticity
Change in spinal excitability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Spinal Cord Injuries

Trial Design

4 Treatment Groups

Effects of single-dose L-DOPA/carbidopa on CNS Excitability
1 of 4
Effects of single-dose 5HTP/carbidopa on CNS Excitability
1 of 4
Effects of single-dose placebo on CNS Excitability
1 of 4
Effects of single-dose of carbidopa (50mg) on CNS excitability
1 of 4
Active Control
Non-Treatment Group

This trial requires 30 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Effects of single-dose L-DOPA/carbidopa on CNS Excitability
Drug
During one of the four occasions participants visit the lab they will receive L-DOPA combined with carbidopa (50-200mg L-DOPA/50mg carbidopa). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.
Effects of single-dose placebo on CNS Excitability
Drug
Participants will visit the lab and on one of four different occasions and will receive a placebo. Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.
Effects of single-dose 5HTP/carbidopa on CNS Excitability
Drug
During one of the four occasions participants visit the lab they will receive 5HTP combined with carbidopa (50-200mg HTP/50mg carbidopa). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.
Effects of single-dose of carbidopa (50mg) on CNS excitability
Drug
Participants will visit the lab and on one of four different occasions they will receive carbidopa only (50 mg). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake for reporting.

Closest Location

University of Louisville, Kentucky Spinal Cord Injury Research Centre - Louisville, KY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People aged 18 to 65 years old. show original
The patients must have experienced a trauma to their spinal cord at least 1 year ago or longer. show original
must be recorded Patients with spasticity must exhibit some degree of spasticity, which can be self-reported (Penn spasm frequency) or if assessed by a physiotherapist, a modified Ashworth spasticity score greater than 1 must be recorded. show original

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

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Get access to this novel treatment for Spinal Cord Injuries by sharing your contact details with the study coordinator.