RECRUITING

Task Practice and Spinal Cord Stimulation

Conditions

Spinal Cord Injury Cervical Spastic Transcutaneous Transcutaneous Cervical Spinal Cord Stimulation

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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 goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.

Official Title

Task Practice Combined with Transcutaneous Spinal Cord Stimulation to Reduce Muscle Co-contraction and Improve Motor Function in Chronic Spinal Cord Injury

Quick Facts

Study Start:2024-09-01

Study Completion:2027-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06494020

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 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 22-70 years of age * Non-progressive cervical spinal cord injury * Minimum 12 months year post-injury. * American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D. * Able to take part in upper extremity therapy procedures. * GRASSP-Prehension score ≥10. * MAS Score ≥3 but \<6 in at least one arm. * Can commit to the time required for the study. * Stable medication profile for at least 4 weeks prior to enrollment. * Able to reduce Baclofen dose to 30 mg or less daily. * Capable of providing informed consent.	* Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders. * Has uncontrolled cardiopulmonary disease or cardiac symptoms. * Requires ventilator support. * Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled. * Has an autoimmune etiology of spinal cord dysfunction/injury * Previously diagnosed as having transverse myelitis * History of additional neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy or history of seizures. * Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) * Uncontrolled spasms, which have been unstable over the past three months prior to enrollment and are not expected to change. * Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment. * Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at the time of enrollment. * Breakdown in skin area that will come into contact with electrodes. * Presence of syringomyelia as determined by an MRI. * Currently undergoing treatment for cancer or has been in remission for less than 2 years. * Received stem cell treatment within the past two years prior to enrollment. * Has any active implanted medical device. * Concurrent participation in another drug or device trial that may interfere with this study. * In the opinion of the investigators, the study is not safe or appropriate for the participant. * Persons who are unable to consent, pregnant women, and prisoners.

Inclusion Criteria

Exclusion Criteria

* 22-70 years of age
* Non-progressive cervical spinal cord injury
* Minimum 12 months year post-injury.
* American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
* Able to take part in upper extremity therapy procedures.
* GRASSP-Prehension score ≥10.
* MAS Score ≥3 but \<6 in at least one arm.
* Can commit to the time required for the study.
* Stable medication profile for at least 4 weeks prior to enrollment.
* Able to reduce Baclofen dose to 30 mg or less daily.
* Capable of providing informed consent.

* Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders.
* Has uncontrolled cardiopulmonary disease or cardiac symptoms.
* Requires ventilator support.
* Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
* Has an autoimmune etiology of spinal cord dysfunction/injury
* Previously diagnosed as having transverse myelitis
* History of additional neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy or history of seizures.
* Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
* Uncontrolled spasms, which have been unstable over the past three months prior to enrollment and are not expected to change.
* Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment.
* Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at the time of enrollment.
* Breakdown in skin area that will come into contact with electrodes.
* Presence of syringomyelia as determined by an MRI.
* Currently undergoing treatment for cancer or has been in remission for less than 2 years.
* Received stem cell treatment within the past two years prior to enrollment.
* Has any active implanted medical device.
* Concurrent participation in another drug or device trial that may interfere with this study.
* In the opinion of the investigators, the study is not safe or appropriate for the participant.
* Persons who are unable to consent, pregnant women, and prisoners.

Contacts and Locations

Study Contact

Nilanjana Datta, MD

CONTACT

3052436798

nx693@med.miami.edu

Principal Investigator

James Guest, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami - Christine E. Lynn Rehabilitation Center

Miami, Florida, 33136

United States

University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

James Guest, MD, 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 Date2024-09-01

Study Completion Date2027-10-01

Study Record Updates

Study Start Date2024-09-01

Study Completion Date2027-10-01

Terms related to this study

Keywords Provided by Researchers

Transcutaneous
Transcutaneous Cervical Spinal Cord Stimulation

Additional Relevant MeSH Terms

Spinal Cord Injury Cervical
Spastic