NCT07467850

Dual Stimulation for Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Spinal Cord Injury (SCI) Open-Label Clinical Trial is to test the safety and feasibility of the intervention. The study aims to answer whether implementing this intervention on inpatients at a specialized rehabilitation hospital is possible. All participants will receive the intervention and be asked to report side effects and tolerability. Additionally, injury markers for safety and signal recordings to detect changes will be assessed pre- and post-intervention.

Detailed description

This proposal seeks to apply non-invasive technology for hyperexcitability suppression, decrease inflammation, and promote restorative processes along the neural axis and the brain in patients with complete SCI in a highly innovative treatment paradigm with the potential for large-scale clinical impact. This project will be the first to examine the proposed treatment approach in subacute inpatients with complete SCI. This will be a pilot open-label study using historical controls from the Spinal Cord Injury Model Data Center. A follow-up period (3- and 6-month post-intervention) will be required to evaluate the progression of these patients. The investigators aim to recruit eight patients based on historical admissions data from our institution. Specific aims for this project are: Aim 1: To assess safety and feasibility. Investigators will begin subject enrollment from the SCI inpatient unit at Spaulding Rehabilitation Hospital. The investigators will explore the effects of non-invasive neuromodulation + photobiomodulation among hospitalized American Spinal Cord Injury Association (ASIA) A/B patients (i.e., through analysis of enrollment, treatment tolerability, retention, medication use, and adverse effects). Aim 2: To explore neurophysiological and clinical markers associated with recovery in SCI. The investigators will evaluate inpatient evolution by measuring standard clinical assessments of sensorimotor function, the visual analog scale (VAS) for pain, the SCI pain interference scale, the modified Ashworth scale (MAS) for spasticity, and the Spinal Cord Injury - Quality of Life measurement system SCI-QOL. Neurophysiological markers will include surface electromyography (sEMG) to evaluate biological markers of corticospinal activity and sympathetic skin responses (SSR) to assess sudomotor function. Aim 3: To explore mental health and cognitive function in this group of patients and assess this therapeutical approach's impact. Hypothesis Concerning Aim 1, The hypothesis is that the intervention and research procedures will be feasible and safe as evidenced by successful recruitment, screening, eligibility, enrollment rates, tolerability, low or mild adverse events, and no increased levels of specific enolase after the intervention. The hypothesis for Aim 2 is that neurophysiological measurement will be feasible to collect and use as evidenced by tolerability to the procedures, quality, and reliability of the recorded signals, and viability and accuracy of the processing and analyses. In the Aim 3 hypothesis, investigators can assess mental health and cognitive function successfully in this group of patients. The data from measures collected in this study will identify patterns across the time points, providing information for designing a future efficacy trial.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	tsDCS+pDCS	Pathmaker Neurosystems Inc. "MyoRegulator" trans-spinal and peripheral direct current stimulation.
DEVICE	Low-level laser therapy	Erchonia Corp. "Erchonia FX405" low level laser

Timeline

• Start date: 2022-07-14
• Primary completion: 2024-07-01
• Completion: 2024-09-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study