RECRUITING

A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

Quick Facts

Study Start:2024-11-04

Study Completion:2026-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06494059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 18 years old and no older than 70 years old at the time of enrollment. 2. Able-bodied subjects 3. Traumatic spinal cord injury 4. Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory; * Lower limb target: neurological level at or above Thoracic 10 level, with residual lower limb function; AIS B, C or D impairment grade primary could ambulate; * Trunk target: neurological at or above Thoracic 5, AIS A, B, C or D impairment grade, primary wheelchair user 5. Spinal cord injury sustained more than 6 months prior to study. 6. Movement/excitability/etc: * Upper limb target: Has detectable residual connection in upper-limb muscles in at least one side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) and a visible contraction when functional electrical stimulation (FES) is applied in the hand or wrist muscle at baseline. * Lower limb target: Has detectable residual connection in lower-limb muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in lower limb ankle plantar or dorsiflexor muscle at baseline. * Trunk target: Has detectable residual connection in trunk muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in trunk muscle at baseline. 7. Able to commit to intervention and assessment sessions over a maximum duration of 2 months.	1. Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function. 2. Has severe spasticity that could prevent the study protocol as determined by the investigator. 3. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities. 4. Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease. 5. Has a poorly managed autonomic dysreflexia that could be triggered by transcranial magnetic stimulation (TMS), FES, or TSCS. 6. Has a history of prior intracranial surgery or known medical risks that would limit TMS protocols. 7. Has a history of epilepsy, convulsion or seizures. 8. Individuals with metal implants in their head or spine near the sites to be stimulated and other implantable devices (e.g., cochlear implants) in the body that could be affected by TMS or TSCS. 9. Has implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation or VNS). 10. Has a cardiac pacemaker or intracardiac lines. 11. Has peripheral neuropathy, including diabetic polyneuropathy and entrapment neuropathy. 12. Has urinary tract infection, unhealed fracture, contracture, and pressure sore as determined by Braden Scale value of 14 and below. 13. Individuals who require therapy or other care that could interfere with participation in the study. 14. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function. 15. Individuals with substance disorders, including alcoholism and drug abuse. 16. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study. 17. In the opinion of the investigators, the study is not safe or appropriate for the participant.

Inclusion Criteria

Exclusion Criteria

1. At least 18 years old and no older than 70 years old at the time of enrollment.
2. Able-bodied subjects
3. Traumatic spinal cord injury
4. Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;
* Lower limb target: neurological level at or above Thoracic 10 level, with residual lower limb function; AIS B, C or D impairment grade primary could ambulate;
* Trunk target: neurological at or above Thoracic 5, AIS A, B, C or D impairment grade, primary wheelchair user
5. Spinal cord injury sustained more than 6 months prior to study.
6. Movement/excitability/etc:
* Upper limb target: Has detectable residual connection in upper-limb muscles in at least one side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) and a visible contraction when functional electrical stimulation (FES) is applied in the hand or wrist muscle at baseline.
* Lower limb target: Has detectable residual connection in lower-limb muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in lower limb ankle plantar or dorsiflexor muscle at baseline.
* Trunk target: Has detectable residual connection in trunk muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in trunk muscle at baseline.
7. Able to commit to intervention and assessment sessions over a maximum duration of 2 months.

1. Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
2. Has severe spasticity that could prevent the study protocol as determined by the investigator.
3. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
4. Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease.
5. Has a poorly managed autonomic dysreflexia that could be triggered by transcranial magnetic stimulation (TMS), FES, or TSCS.
6. Has a history of prior intracranial surgery or known medical risks that would limit TMS protocols.
7. Has a history of epilepsy, convulsion or seizures.
8. Individuals with metal implants in their head or spine near the sites to be stimulated and other implantable devices (e.g., cochlear implants) in the body that could be affected by TMS or TSCS.
9. Has implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation or VNS).
10. Has a cardiac pacemaker or intracardiac lines.
11. Has peripheral neuropathy, including diabetic polyneuropathy and entrapment neuropathy.
12. Has urinary tract infection, unhealed fracture, contracture, and pressure sore as determined by Braden Scale value of 14 and below.
13. Individuals who require therapy or other care that could interfere with participation in the study.
14. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
15. Individuals with substance disorders, including alcoholism and drug abuse.
16. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
17. In the opinion of the investigators, the study is not safe or appropriate for the participant.

Contacts and Locations

Study Contact

Deena Cilien, DPT

CONTACT

(305) 243-9301

dcilien@med.miami.edu

Matija Milosevic, PhD

CONTACT

(305) 243-3572

mmilosevic@med.miami.edu

Principal Investigator

Matija Milosevic, PhD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Matija Milosevic, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-04

Study Completion Date2026-12-30

Study Record Updates

Study Start Date2024-11-04

Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

SCI - Spinal Cord Injury