RECRUITING

AMPLIFY Study: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After SCI

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Conditions

Spinal Cord Injuries

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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

Locomotor training (LT) facilitates recovery of spinal locomotor networks after incomplete spinal cord injury (ISCI), but walking impairments persist. A limitation of LT is insufficient excitation of spinal locomotor circuits to induce neuroplastic recovery. Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive approach to increase spinal excitation and modulate spinal reflexes. The study will examine if tsDCS combined with LT enhances locomotor rehabilitation after ISCI.

Official Title

Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After Spinal Cord Injury

Quick Facts

Study Start:2023-03-10
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05700942

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18 to 65 years of age
  2. * Single chronic SCI for ≥ 1 year classified as neurologic level T12 or above based on the International Standards for the Neurological Classification of SCI67 and classified according to the American Spinal Injury Association Impairment Scale (AIS) as motor incomplete (AIS C or D) at initial screening
  3. * Medical stability with clearance from physician
  4. * Ability to walk 3 meters with or without devices, braces, or assistance of one person
  5. * Ability to provide informed consent.
  1. * Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
  2. * Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction (\<1 year prior), pulmonary infection or illness, renal disease, autonomic dysreflexia, infections, pain, heterotopic ossification
  3. * Cognitive or communication impairments limiting communication with study staff or ability to provide informed consent
  4. * Lower extremity joint contractures limiting the ability to stand upright and practice walking
  5. * Skin lesions or wounds affecting participation in walking rehabilitation
  6. * Acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking rehabilitation
  7. * Severe spasticity or uncontrolled movements limiting participation in walking rehabilitation
  8. * Body weight or height that is incompatible with safe use of a support harness and body weight support system
  9. * Pain that limits walking or participation in walking rehabilitation
  10. * Current participation in rehabilitation to address walking function
  11. * Botox injections in lower extremity muscles affecting walking function within 4 months of study enrollment
  12. * Legal blindness or severe visual impairment
  13. * Known pregnancy
  14. * Implanted metal hardware of the spine below the 8th thoracic vertebrae or in region of electrode placement
  15. * Implanted cardiac pacemaker or baclofen pump

Contacts and Locations

Study Contact

Hannah Snyder, MS
CONTACT
904-345-6910
hannah.snyder@brooksrehab.org

Principal Investigator

Emily Fox, DPT, PhD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Emily Fox, DPT, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

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 Date2023-03-10
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-03-10
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries