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Double Dose 4-AP on Functional Recovery After Spinal Cord Injury

NCT06853015 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-04-03

No results posted yet for this study

Summary

The purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (SCI). The FDA approved drug, Dalfampridine (4-AP). 4-AP will be used twice-daily in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Conditions

  • SCI - Spinal Cord Injury

Interventions

DRUG

Dalfampridine

The study drug (4-AP) will be administered as a 10 mg dose twice a day.

DRUG

Placebo

The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.

OTHER

STDP stimulation

Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.

BEHAVIORAL

Exercise training

Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.

Sponsors & Collaborators

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Monica Perez, PT, PhD · Shirley Ryan Ability Lab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06853015 on ClinicalTrials.gov