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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the effects of different types of stimulation—magnetic stimulation to activate the brain, electrical spinal cord stimulation, and electrical muscle stimulation—on people with spinal cord injury (SCI) and able-bodied individuals. The study focuses on activating muscles in the arms, legs, and trunk to understand how these stimulations impact neuromotor function in these groups. Participants will receive interventions including intermittent theta burst stimulation (iTBS), functional electrical stimulation (FES), and transcutaneous spinal cord stimulation (TSCS). Each treatment uses devices that apply magnetic or electrical pulses to activate specific brain regions, spinal cord areas, or muscles. There is also a sham iTBS group where a magnetic coil is placed but no stimulation is given. Each participant will attend at least 9 sessions over two months, with each visit lasting about 2 to 3 hours. Participants are grouped based on their injury status and ambulatory ability. During the study, participants will undergo assessments including the nine-hole peg test, foot tapping test, Function in Sitting Test for people with SCI, and Motor Evoked Potential measurements. These tests will be conducted at the start and throughout the two-month period to monitor changes. The study will evaluate how the different stimulations affect motor function and neuromuscular responses over time.
CONDITIONS
Brief 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 individuals or those with traumatic spinal cord injury
- For upper limb target: neurological level at or above Thoracic 1 with AIS B, C, or D impairment, primary non-ambulatory
- For lower limb target: neurological level at or above Thoracic 10 with residual lower limb function, AIS B, C, or D, may ambulate
- For trunk target: neurological level at or above Thoracic 5 with 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 electromyography or motor evoked potential and visible contraction with functional electrical stimulation
- Ability to commit to intervention and assessments over up to 2 months
You will not qualify if you...
- History of traumatic brain injury, stroke, multiple sclerosis, or other neurological disorders affecting neuromotor function
- Severe spasticity preventing study participation
- Major executive dysfunction, dementia, depression, neurocognitive impairments, or significant medical co-morbidities
- Contraindications for transcutaneous stimulation such as skin breakdown, thrombosis, or skin disease
- Poorly managed autonomic dysreflexia triggered by study stimulations
- Prior intracranial surgery or medical risks limiting TMS
- History of epilepsy, convulsions, or seizures
- Metal implants in head or spine, or implantable devices like cochlear implants
- Implanted neurostimulators such as deep brain stimulation or vagal nerve stimulation
- Cardiac pacemaker or intracardiac lines
- Peripheral neuropathy including diabetic or entrapment neuropathy
- Urinary tract infection, unhealed fractures, contractures, or pressure sores with low Braden Scale
- Need for therapy or care interfering with study participation
- Use of investigational drugs or interventions affecting neuromotor function
- Substance use disorders including alcoholism and drug abuse
- Pregnancy, breastfeeding, or desire to become pregnant during the study
- Investigator judgment deeming study unsafe or inappropriate
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 9 sessions over 2 months
Participants receive neuromodulation interventions including intermittent theta burst stimulation (iTBS), functional electrical stimulation (FES), or transcutaneous spinal cord stimulation (TSCS) targeting upper limb, lower limb, or trunk muscles. Some participants may receive sham iTBS as a control. Sessions are longitudinal and involve activation of muscles or nerves using magnetic or electrical stimulation.
At least 9 visits, each lasting approximately 2-3 hours
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
D
Deena Cilien, DPT
M
Matija Milosevic, PhD
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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