Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06494059

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

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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