Twice-Daily 4-AP for Spinal Cord Injury Recovery
Dalfampridine
+ STDP stimulation
+ Exercise training
Central Nervous System Diseases+3
+ Nervous System Diseases
+ Spinal Cord Diseases
Treatment Study
Summary
Study start date: February 1, 2025
Actual date on which the first participant was enrolled.This study is looking into how a drug called 4-AP can help people recover better after a spinal cord injury. The focus is on individuals with chronic spinal cord injuries who experience problems with movement and sensation. Previous research suggests that 4-AP can improve both sensory and motor functions, reduce muscle stiffness, increase sensation, and lessen pain. The study is particularly interested in seeing if taking this medication twice a day can keep the drug levels in the body steady, which might improve its benefits. By combining the drug with specific limb training techniques, researchers hope to enhance the body's ability to recover movement by promoting changes in the brain and spinal cord pathways that control movement. Participants in the study will receive 4-AP in a sustained release form, meaning it is designed to be taken orally twice a day to maintain consistent drug levels in the blood. Alongside taking the medication, they will undergo specialized exercises aimed at improving limb movement. The study will look at how these treatments together can improve lower limb motor function. There are no specified outcomes listed, but the main focus is to observe any improvements in movement and sensation, and how these changes relate to the body's pathways for movement. As with any medical study, there is a possibility of risks, but the goal is to find out if the benefits of 4-AP can be maximized when combined with targeted limb training.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location