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Dalfampridine + Stimulation/Exercise for Spinal Cord Injury
Study Summary
This trial will test if a combination of the drug 4-AP and two types of stimulation can help improve lower limb motor function in people with SCI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can slightly move my toes upwards and bend my hip.I am currently taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or drugs that prolong the PR Interval.I am a woman of childbearing age unsure about being pregnant and refuse a pregnancy test, or I have a spinal cord condition.My spinal cord injury happened over 4 weeks ago.I have had a head injury or stroke in the past.I had a condition before my spinal cord injury that made it hard for me to exercise.I do not have unmanaged heart, lung, or bone problems.My spinal cord injury is at or above the L2 level.I am taking medication that could increase my risk of seizures.I have had kidney problems in the past.I am between 18 and 85 years old.I have a history of seizures or epilepsy.My spinal cord injury is at or above the L2 level.I can slightly move my toes upwards and bend my hip.My spinal cord injury level is graded ASIA A, B, C, or D.I have a brain condition not caused by seizures and I'm not on seizure medication.I am between 18 and 85 years old.You need to be able to do the following things:My spinal cord injury level is classified as ASIA A, B, C, or D.My spinal cord injury happened over 4 weeks ago.
- Group 1: Dalfampridine (4-AP)+STDP+training for extended sessions
- Group 2: Dalfampridine (4-AP)+STDP+training
- Group 3: Placebo+STDP+training
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
Are people still able to sign up for this test?
"That is correct. The clinicaltrials.gov website contains information suggesting that this study is still searching for subjects. This research was initially posted on 6/30/2022 and updated as recently as 7/6/2022. So far, 44 patients have been recruited from 1 site."
Will this experiment be testing on any elderly individuals?
"For this specific trial, only patients aged 18 to 85 are eligible. However, there are a total of 39 clinical trials for minors and 324 trails available for elderly patients."
What hope does this research bring for patients?
"The primary outcome of this trial, as evaluated over the change in MVC, will be measured at baseline and 3 weeks for Dalfampridine+STDP+training and Placebo+STDP+training groups. TMEPs will be measured at baseline, 6 weeks, and 12 weeks for extended sessions group. The secondary objectives include Change in surveys on ambulation, basic mobility, bowel and bladder management difficulties which is defined as The name of the questionnaire is Spinal cord injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and"
What is the total number of volunteers for this research project?
"That is correct. The clinicaltrial.gov website has the most recent information on this topic and it states that the study was posted on 6/30/2022 and was last updated on 7/6/2022. The trial is looking for 44 individuals total, from 1 location."
How can I join this clinical research?
"This study is looking for 44 participants, both male and female, who are between 18 and 85 years old. In order to be eligible, patients must have suffered a spinal cord injury (SCI) at least 4 weeks prior to enrolling in the trial, with the injury occurring at or above the L2 level on the spine. Additionally, participants must be classified as ASIA A, B, C, or D (complete or incomplete), and must be able to perform small muscle contractions in their dorsiflexion and hip flexor muscles."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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