Clinical trial NCT05994846: Non-Invasive Electrical and Magnetic Neuromodulation in Persons With Chronic Spinal
Official title: The Reynolds Innovative Spinal Electrical Stimulation Program: Transcutaneous Stimulation (RISES-T 2.0)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Keywords: Spinal Cord Injuries
Spinal Electrical Stimulation
Transcutaneous Spinal Stimulation
Transcutaneous Magnetic Simulation
Transcranial Magnetic Stimulation
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, unblinded, feasibility study where participants will serve as their own controls.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

Has a non-progressive or central cord spinal cord injury

American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A, B, C, or D

Can participate in physical and occupational therapy rehabilitation programs

Is at minimum 12 months post-injury

Can provide informed consent

Has adequate caregiver support to facilitate participation in study

Is willing to undergo audio-visual recording sessions

-

Exclusion Criteria:

Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by investigators)

Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disorders

Has autonomic dysreflexia that is severe, unstable, and uncontrolled or uncontrolled orthostatic hypotension that may interfere with rehabilitation.

Requires ventilator support Has an autoimmune etiology of spinal cord dysfunction/injury

Has spasms that limit the ability to participate in the study training (as determined by the Investigator)

Has skin breakdown in area(s) that will come into contact with electrodes

Has any active implanted medical device (e.g., cochlear implant, pacemaker, neurostimulator or medication infusion device) Is pregnant, planning to become pregnant or currently breastfeeding

Has concurrent participation in another drug or device trial that may interfere with this study

Has other traumatic injuries such as peripheral nerve injuries, severe musculoskeletal injuries (e.g., shattered pelvis, long bone fractures), that prevent evaluation of response to or participation in rehabilitation.

Is not a candidate for other reason determined by the investigators

-

Primary outcomes:
measure: Spinal Cord Injury-Motor Index (SCI MovIN)
timeFrame: Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks
measure: Manual Muscle Testing (MMT)
timeFrame: Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks
Secondary outcomes:
measure: Capabilities of Upper Extremity Test (CUE-T)
timeFrame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
measure: PROMIS Pain Interference- Adult Short Form 8a (PROMIS-PI)
timeFrame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
measure: Walking Index for SCI (WISCI-II)
timeFrame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
measure: Patient Global Impression of Change (PGIC) Questionnaires (bowel program, bladder function, dysreflexia, pain, sensation)
timeFrame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
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