RECRUITING

Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury

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 identify the effect of different types of noninvasive spinal stimulation on spasticity (involuntary muscle activity), muscle strength, and pain in people with spinal cord injury. The spinal stimulation consists of electrical stimulation applied through one electrode over the skin of the lower back and two electrodes over the stomach. Testing will include participating in measurements before the intervention, during intervention, and immediately after the intervention. This study requires participants to come into Shepherd Center 4 consecutive days a week for 2-3 hours per day across 2-3 weeks.

Official Title

Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)

Quick Facts

Study Start:2024-02-19
Study Completion:2026-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06214208

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:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must agree to allow use of health information.
  2. * Participants should be 16 years old or older.
  3. * Participants must have had a spinal cord injury (SCI) of any severity (AIS A, B, C, or D) that happened at least 3 months ago.
  4. * Participants should have at least a small amount of spasticity in the legs.
  5. * Participants must inform the investigators if there is a change in medications during the study.
  6. * Participants must be able to follow instructions.
  7. * Participants must be able to communicate if pain or discomfort is experienced.
  1. * People with spinal issues that are getting worse, such as degenerative or progressive vascular disorders.
  2. * People neurological problems other than SCI.
  3. * People with an injury level is below T12.
  4. * People with heart issues, such as atrial fibrillation.
  5. * People with bone or joint problems that would make it hard to follow the study plan.
  6. * Women who are pregnant.
  7. * People with implanted stimulators (like a baclofen pump, spinal stimulator, heart defibrillator, or diaphragmatic pacemaker)
  8. * People with infection.
  9. * People with skin that is broken.
  10. * People who have or had certain types of cancer.
  11. * People who have had long-lasting spasticity treatment (like botox or selective dorsal rhizotomy).

Contacts and Locations

Study Contact

Kelly Thatcher, PT, DPT
CONTACT
404-350-7681
kelly.thatcher@shepherd.org
Evan Sandler, PT, DPT
CONTACT
404-603-4175
evan.sandler@shepherd.org

Principal Investigator

Edelle C Field-Fote, PT, PhD
PRINCIPAL_INVESTIGATOR
Shepherd Center, Atlanta GA

Study Locations (Sites)

Shepherd Center, Inc.
Atlanta, Georgia, 30309
United States

Collaborators and Investigators

Sponsor: Shepherd Center, Atlanta GA

  • Edelle C Field-Fote, PT, PhD, PRINCIPAL_INVESTIGATOR, Shepherd Center, Atlanta GA

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 Date2024-02-19
Study Completion Date2026-12-15

Study Record Updates

Study Start Date2024-02-19
Study Completion Date2026-12-15

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries