RECRUITING

Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)

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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 test the effectiveness of a new therapy, called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS), for improving walking in people with an incomplete spinal cord injury (SCI).

Official Title

Brain-Controlled Spinal Stimulation Therapy for Restoration of Walking After Incomplete Spinal Cord Injury (SCI)

Quick Facts

Study Start:2024-05-07

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06406855

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:No

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. Traumatic incomplete spinal cord injury (neurological level at or above T10 spinal cord level; Abbreviated Injury Scale (AIS) C or D impairment grade for group 1, 3 and 4 and AIS B, C or D impairment grade for group 2), who are more than 6 months post-injury. 3. Has detectable motor function in at least 2 muscles per side confirmed by voluntary Electromyography (EMG) or detectable tibialis anterior (TA) muscle motor evoked potentials (MEPs) at the baseline assessment. 4. Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months. 5. Could effectively walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support, with functional spasticity (by participant's self-report), functional range-of-motion of lower limb joints, and acceptable bone mass to enable body-weight support, confirmed by Dual-energy X-ray absorptiometry (DXA) scan.	1. Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking. 2. Has severe spasticity that could prevent stepping and walking function determined by the investigator. 3. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities. 4. Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS). 5. Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS. 6. Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings. 7. Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS. 8. Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.). 9. Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale). 10. Has breakdown in skin area that will come into contact with electrodes. 11. Individuals who require therapy or other care that could interfere with participation in the study. 12. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function. 13. Individuals with substance disorders, including alcoholism and drug abuse. 14. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study. 15. 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. Traumatic incomplete spinal cord injury (neurological level at or above T10 spinal cord level; Abbreviated Injury Scale (AIS) C or D impairment grade for group 1, 3 and 4 and AIS B, C or D impairment grade for group 2), who are more than 6 months post-injury.
3. Has detectable motor function in at least 2 muscles per side confirmed by voluntary Electromyography (EMG) or detectable tibialis anterior (TA) muscle motor evoked potentials (MEPs) at the baseline assessment.
4. Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months.
5. Could effectively walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support, with functional spasticity (by participant's self-report), functional range-of-motion of lower limb joints, and acceptable bone mass to enable body-weight support, confirmed by Dual-energy X-ray absorptiometry (DXA) scan.

1. Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
2. Has severe spasticity that could prevent stepping and walking function determined by the investigator.
3. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
4. Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS).
5. Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
6. Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
7. Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS.
8. Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
9. Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale).
10. Has breakdown in skin area that will come into contact with electrodes.
11. Individuals who require therapy or other care that could interfere with participation in the study.
12. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
13. Individuals with substance disorders, including alcoholism and drug abuse.
14. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
15. 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 - MSOM

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 - MSOM

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 Date2024-05-07

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-05-07

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Spinal Cord Injuries