What is this study trying to find out about spinal cord injury?

This study is examining how different types of magnetic and electrical stimulation affect muscle and nerve function in people with spinal cord injury compared to those without. Researchers want to understand how activating the brain, spinal cord, and muscles might improve neuromotor connections. The study is sponsored by the University of Miami.

Who may be eligible for this spinal cord injury clinical trial?

Adults aged 18 to 70 years with traumatic spinal cord injury or able-bodied individuals may qualify. Participants should have specific levels and types of spinal cord injury or no injury at all and be able to commit to study sessions over two months. There are also health criteria excluding those with certain neurological conditions or implants. Please review eligibility criteria for more details.

Is there any cost to participate in this spinal cord injury clinical trial?

Study-related care, including the study treatments and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 70Years

All Genders

Healthy Volunteers

ID06494059

Exploring Brain and Spinal Cord Stimulation to Improve Muscle Function in Adults with Spinal Cord Injury and Able-Bodied Adults

Led by University of Miami · Updated on 2026-04-23

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are exploring the effects of different types of stimulationmagnetic stimulation to activate the brain, electrical spinal cord stimulation, and electrical muscle stimulationon 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

Age: 18Years - 70Years

All Genders

Healthy Volunteers

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

Research Team

Deena Cilien, DPT

Matija Milosevic, PhD

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