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Effects of 4-AP on Functional SCI Recovery

NCT05447676 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-06-22

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 in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Conditions

  • Spinal Cord Injury

Interventions

DRUG

Dalfampridine

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

OTHER

Placebo drug

The pharmacy will also provide a placebo drug that looks identical to 4-AP to verify participants and therapists do not know who is receiving the drug and who is receiving the placebo.

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

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05447676 on ClinicalTrials.gov