RECRUITING

Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury

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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

It has been demonstrated that the human lumbosacral spinal cord can be neuromodulated with epidural (ESS) and transcutaneous (TSS) spinal cord stimulation to enable recovery of standing and volitional control of the lower limbs after complete motor paralysis due to spinal cord injury (SCI). The work proposed herein will examine and identify distinct electrophysiological mechanisms underlying transcutaneous spinal stimulation (TSS) and epidural spinal stimulation (ESS) to define how these approaches determine the ability to maintain self-assisted standing after SCI.

Official Title

Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury

Quick Facts

Study Start:2023-12-06

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06213012

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:22 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* All participants must be able to provide a provision of a signed and dated informed consent form. * Male or female, aged 22-60 years old Able to provide paperwork from personal primary treating physician that proves stable medical condition with ability to tolerate at least 15 minutes upright * Able to self-transfer from the wheelchair and demonstrate active range of motion of bilateral upper extremities in gravity dependent plane * Able to passively range bilateral lower extremities within normal mobility parameters including: greater than 90 degrees of hip flexion and 165 degrees of hip extension; greater than 90 degrees of knee flexion and reach neutral knee extension of 180 degrees; neutral ankle position reaching a minimum of 90 degrees of dorsiflexion. * Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes. * 1 to 6 years post spinal cord injury * Non-progressive spinal cord injury * Chronic motor complete SCI as defined by AIS A or B * Neurological level of injury below T2 and above T10 (non-conus injury) * Eligible for fMRI per safety questionnaire * Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study. * Able to commit to the full study	* Currently involved in another rehabilitation training study * Active pressure sores, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including but not limited to contractures in the upper and lower extremities) * Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing) * Intrathecal baclofen pump therapy for spasticity * Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months, resulting in absence of muscle tone and precluding response to electrical stimulation therapy * Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities). * Clinically significant depression, psychiatric disorders, or ongoing drug abuse * Any reason the PI or treating physician may deem as harmful to the participant to enroll or continue in the study * Body Mass Index (BMI) over 30 * Pregnancy

Inclusion Criteria

Exclusion Criteria

* All participants must be able to provide a provision of a signed and dated informed consent form.
* Male or female, aged 22-60 years old Able to provide paperwork from personal primary treating physician that proves stable medical condition with ability to tolerate at least 15 minutes upright
* Able to self-transfer from the wheelchair and demonstrate active range of motion of bilateral upper extremities in gravity dependent plane
* Able to passively range bilateral lower extremities within normal mobility parameters including: greater than 90 degrees of hip flexion and 165 degrees of hip extension; greater than 90 degrees of knee flexion and reach neutral knee extension of 180 degrees; neutral ankle position reaching a minimum of 90 degrees of dorsiflexion.
* Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes.
* 1 to 6 years post spinal cord injury
* Non-progressive spinal cord injury
* Chronic motor complete SCI as defined by AIS A or B
* Neurological level of injury below T2 and above T10 (non-conus injury)
* Eligible for fMRI per safety questionnaire
* Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.
* Able to commit to the full study

* Currently involved in another rehabilitation training study
* Active pressure sores, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including but not limited to contractures in the upper and lower extremities)
* Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing)
* Intrathecal baclofen pump therapy for spasticity
* Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months, resulting in absence of muscle tone and precluding response to electrical stimulation therapy
* Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
* Clinically significant depression, psychiatric disorders, or ongoing drug abuse
* Any reason the PI or treating physician may deem as harmful to the participant to enroll or continue in the study
* Body Mass Index (BMI) over 30
* Pregnancy

Contacts and Locations

Study Contact

Rachel Markley, MPH

CONTACT

(713)-441-3770

rmarkley@houstonmethodist.org

Jenny Dinh

CONTACT

(346)-238-4654

jtdinh@houstonmethodist.org

Principal Investigator

Dimitry Sayenko, MD, PhD

PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

Dimitry Sayenko, MD, PhD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

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 Date2023-12-06

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-12-06

Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

Spinal Cord Injuries
Neuromodulation