NCT05994846

Non-Invasive Electrical and Magnetic Neuromodulation in Persons With Chronic Spinal

The Reynolds Innovative Spinal Electrical Stimulation Program: Transcutaneous Stimulation (RISES-T 2.0)

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to (1) determine the effects of neuromodulation techniques on mobility in persons with chronic SCI, as measured by subjective and objective measures, and (2) to determine the optimal combination of techniques that modify mobility and movement in an individual. The neuromodulation techniques explored will be methods of electromagnetic stimulation - that is, electrical stimulation and magnetic stimulation.

Detailed description

The study is designed in two Parts. Part 1 of the study will collect information about the participant's baseline mobility and muscular activation potential. The information collected in these sessions will, in effect, assess the participant's eligibility to continue in the study and move onto Part 2. Part 1- Assessment Sessions This part of the study designed to determine (1) which, if any, of the participant's muscles respond to stimulation and, if there are responses observed, (2) what stimulation parameters and modalities would be best suited for the participant during Part 2 of the trial. The team will create a participant-specific menu of modalities and pre-defined parameters for electromagnetic stimulation (e.g., amplitude, channels, frequencies, electrode placement, etc.) from which they will select for participant visits in Part 2 of the study. They will also capture the participant's Movement Signature (the pattern of movement as measured by accelerometers and surface EMG that a person exhibits while sitting/standing at rest and/or doing specific tasks to inform Part 2 of the study. Finally, the participants will complete a Baseline Clinical Outcome Measures validated for SCI to provide baseline data prior to the neuromodulation intervention. Part 2 - The Experimental Cycles This part of the study will consist of Intervention Sessions, in which the team will apply transcutaneous stimulation to the participant's target muscles identified in Part 1, using the parameters and modalities deemed best suited for the participant. during tasks and activities deemed most appropriate for the targeted muscles. The team will measure the effects of electromagnetic stimulation on the participant's muscle activity and movement. The Cycle will also include Biometric sessions, where the participant will engage in a series of upper extremity, trunk and/or lower extremity repetitive tasks from their prescribed "activity library" that was created for them during Part 1 of the study and the team will measure changes in muscle tone, strength, and movement before and after stimulation. In other sessions, the participant will undergo a series of more targeted tasks with and without electromagnetic stimulation applied, to measure changes in the participant's neurophysiology, kinetics, and kinematics due to electromagnetic stimulation. After a series of Intervention and Biometrics Sessions, if there are no changes observed in the participant's kinematics or EMG signals in the and/or in select outcome measures, the participant will enter a Parameter Optimization Session. During this session, the study team will revisit the library of stimulation parameters that were defined for the participant during Part 1 of the study and refine the parameters for use in the next Experimental Cycle. The manipulation and refinement of these parameters will be done with the aim of achieving changes in the subsequent Experimental Cycle. The participant will continue in the study until the time that there is no observed effect of stimulation for three (3) consecutive Experimental Cycles, or may continue for a maximum of six (6) Experimental Cycles. At the end of the study, the participant will repeat the series of Clinical Outcome Measures that were completed at Baseline.

Conditions

• Spinal Cord Injuries
• Spinal Cord Diseases

Interventions

Type	Name	Description
DEVICE	RISES-T System	The RISES-T system is a hardware and software platform that has been designed and developed to help people living with movement impairment due to Spinal Cord Injury (SCI) to improve and/or restore mobility. The hardware consists of a functional electrical stimulation device that delivers stimulation to the skin through surface electrodes; a series of wearable sensors that collect kinematic (IMU) data and muscle activity (EMG) data, and RISES Software, which incorporates algorithms that utilizes the streaming IMU and EMG sensor data to inform the electrical stimulation parameters and enables real-time visualization of the sensor data and stimulation parameters via Graphical User Interface (GUI).

Timeline

• Start date: 2023-06-23
• Primary completion: 2026-06-23
• Completion: 2026-06-23
• First posted: 2023-08-16
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study