RECRUITING

Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function 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

The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following spinal cord injury.

Official Title

Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury

Quick Facts

Study Start:2022-10-12

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05267951

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:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. has cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - C or D) traumatic spinal cord injury, minimum 1-year post-injury 2. has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding) 3. stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities 4. capable of performing simple cued motor tasks 5. has ability to attend intervention/functional task training and assessment sessions 3 times/week 6. has adequate social support to participate in all intervention and baseline/follow-up assessment sessions throughout 40 weeks. 7. has ability to read and speak English	1. dependent on ventilation support 2. has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump 3. has metallic devices and implants in the head (e.g., deep brain stimulators, aneurysm clips/coils, and stents, vagus nerve stimulators) 4. has a history or current signs/symptoms of syringomyelia (progressive pain, muscle weakness, and/or sensory loss; deterioration of bowel/bladder function) 5. has autoimmune etiology of spinal cord dysfunction/injury 6. has received botulinum toxin injections in upper extremity muscles in the prior 6 months 7. has tendon transfer or nerve transfer surgery in the upper extremity, 8. taking tizanidine, dantrolene or diazepam 9. has history of seizures or increased risk for seizures 10. has history of chronic headaches or migraines 11. has history of neurologic diseases, such as stroke, multiple sclerosis, traumatic brain injury, etc. 12. has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) 13. has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.) 14. has significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation 15. has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention 16. unhealed fracture, contracture, pressure sore, or frequent urinary tract infections or other illnesses that might interfere with upper extremity rehabilitation or testing activities 17. has a history of severe allergy (i.e., allergic reaction that could not be treated with antihistaminic medication 18. has alcohol and/or drug abuse (subject's verbal statement) 19. has cancer 20. pregnant (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation and/or Transcranial Magnetic Stimulation whether the participant could be pregnant. Pregnancy will be ruled out by an over-the-counter urine pregnancy test for all females of childbearing potential (1) at the time of enrollment, (2) prior to all sessions that include Transcranial Magnetic Stimulation, and also prior to the intervention phases of (3) closed-loop or (4) open-loop stimulation. Additional pregnancy tests may be performed if there is a concern of pregnancy.) 21. lack of ability to fully comprehend, cooperate and/or safely perform study procedures in the investigator's opinion/judgment 22. unable to read and/or comprehend the consent form

Inclusion Criteria

Exclusion Criteria

1. has cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - C or D) traumatic spinal cord injury, minimum 1-year post-injury
2. has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding)
3. stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
4. capable of performing simple cued motor tasks
5. has ability to attend intervention/functional task training and assessment sessions 3 times/week
6. has adequate social support to participate in all intervention and baseline/follow-up assessment sessions throughout 40 weeks.
7. has ability to read and speak English

1. dependent on ventilation support
2. has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
3. has metallic devices and implants in the head (e.g., deep brain stimulators, aneurysm clips/coils, and stents, vagus nerve stimulators)
4. has a history or current signs/symptoms of syringomyelia (progressive pain, muscle weakness, and/or sensory loss; deterioration of bowel/bladder function)
5. has autoimmune etiology of spinal cord dysfunction/injury
6. has received botulinum toxin injections in upper extremity muscles in the prior 6 months
7. has tendon transfer or nerve transfer surgery in the upper extremity,
8. taking tizanidine, dantrolene or diazepam
9. has history of seizures or increased risk for seizures
10. has history of chronic headaches or migraines
11. has history of neurologic diseases, such as stroke, multiple sclerosis, traumatic brain injury, etc.
12. has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
13. has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
14. has significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation
15. has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
16. unhealed fracture, contracture, pressure sore, or frequent urinary tract infections or other illnesses that might interfere with upper extremity rehabilitation or testing activities
17. has a history of severe allergy (i.e., allergic reaction that could not be treated with antihistaminic medication
18. has alcohol and/or drug abuse (subject's verbal statement)
19. has cancer
20. pregnant (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation and/or Transcranial Magnetic Stimulation whether the participant could be pregnant. Pregnancy will be ruled out by an over-the-counter urine pregnancy test for all females of childbearing potential (1) at the time of enrollment, (2) prior to all sessions that include Transcranial Magnetic Stimulation, and also prior to the intervention phases of (3) closed-loop or (4) open-loop stimulation. Additional pregnancy tests may be performed if there is a concern of pregnancy.)
21. lack of ability to fully comprehend, cooperate and/or safely perform study procedures in the investigator's opinion/judgment
22. unable to read and/or comprehend the consent form

Contacts and Locations

Study Contact

Fatma Inanici, MD., Ph.D.

CONTACT

206 787 2692

finanici@uw.edu

Principal Investigator

Chet Moritz, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: University of Washington

Chet Moritz, Ph.D., PRINCIPAL_INVESTIGATOR, University of Washington

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 Date2022-10-12

Study Completion Date2024-12

Study Record Updates

Study Start Date2022-10-12

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Spinal Cord Injuries