NCT05708274

Pharmacological Agents for Chronic Spinal Cord Injury (SCI)

The Role of Pharmacological Agents in Restoring Neuronal Excitability After Chronic Spinal Cord Injury (SCI)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bronx VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the short-term effects of 3 approved FDA drugs (cyproheptadine (CPH), carbidopa-levodopa (CD-LD), and atomoxetine (ATX)) on motor responses when delivered in combination with hand training exercises in people with chronic spinal cord injury. The goal is to learn how to better strengthen connections between the brain and spinal cord after spinal cord injury, and if this connection is improved by one(or more) of the drugs. Multiple aspects of nerve transmission and muscle response will be measured via noninvasive brain and spinal cord stimulation, along with motor performance (dexterity and strength).

Detailed description

Research will take place at the James J. Peters VA Medical Center (JJPVAMC), Bronx, NY. There are seven visits in total, including an initial evaluation and clinical assessment session. Each visit will last roughly 5 hours or less. We plan to enroll 28 participants with spinal cord injury over a two-year period. The study is designed as a double-blind, placebo-controlled, single-dose, randomized crossover investigation involving four study drug visits (CPH, CD-LD, ATX, or placebo). The same participants will partake in all four interventions in randomized order with at least 1-week washout representative of greater than 5x drug half-life; to avoid accumulative effects. To reduce potential learning effects from motor training and task-related outcome measurements, participants will partake in two motor training practice sessions prior to commencing the experiments for task familiarity. This study will consist of electromyography (surface recordings of muscle activity), peripheral nerve stimulation, transcranial magnetic brain stimulation (TMS), and transcutaneous electrical spinal cord stimulation (TSCS), targeting the hand/arm muscles. Though it is unlikely given the single-dose nature, participants may experience side effects following drug administration. Prior to consenting, all volunteers will undergo a comprehensive pre-screening evaluation including blood tests to ensure there are no contraindications. Please note, there is no expectation of long-term benefit from this study.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DRUG	CPH + hand training	Following a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements.
DRUG	CD-LD + hand training	Following a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements.
DRUG	ATX + hand training	Following a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements.
DRUG	Placebo + hand training	Following a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements.

Timeline

• Start date: 2023-01-20
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2023-02-01
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study