Actively Recruiting
A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients
Led by University of Miami · Updated on 2026-04-23
25
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).
CONDITIONS
Official Title
A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female subjects
- Age between 18 and 70 years at enrollment
- Able-bodied subjects or traumatic spinal cord injury patients
- For upper limb target: neurological level at or above Thoracic 1, AIS B, C, or D, primarily non-ambulatory
- For lower limb target: neurological level at or above Thoracic 10, AIS B, C, or D, with residual lower limb function, primary could ambulate
- For trunk target: neurological level at or above Thoracic 5, AIS A, B, C, or D, primary wheelchair user
- Spinal cord injury sustained more than 6 months prior to study
- Detectable residual muscle connection confirmed by EMG or motor evoked potential and visible contraction with functional electrical stimulation at baseline
- Able to commit to intervention and assessment sessions over up to 2 months
You will not qualify if you...
- History of traumatic brain injury, stroke, multiple sclerosis, or other disorders affecting neuromotor function
- Severe spasticity preventing study participation
- Major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities
- Contraindications for transcutaneous stimulation such as skin breakdown, thrombosis, or skin disease in electrode areas
- Poorly managed autonomic dysreflexia triggered by stimulation methods
- Prior intracranial surgery or medical risks limiting transcranial magnetic stimulation protocols
- History of epilepsy, convulsions, or seizures
- Metal implants in head or spine near stimulation sites or other implantable devices affected by stimulation
- Implanted neurostimulators like deep brain stimulation, epidural/subdural, or vagal nerve stimulation
- Cardiac pacemaker or intracardiac lines
- Peripheral neuropathy including diabetic or entrapment neuropathy
- Urinary tract infection, unhealed fracture, contracture, or pressure sore with Braden Scale 14 or below
- Need for therapy or care that could interfere with study participation
- Use of investigational drugs or interventions impacting neuromotor function
- Substance disorders including alcoholism or drug abuse
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Any condition making the study unsafe or inappropriate as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
D
Deena Cilien, DPT
CONTACT
M
Matija Milosevic, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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