Recruiting

Spinal Stimulation

Sponsor:

Shepherd Center, Atlanta GA

Code:

NCT06214208

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Spinal Stimulation

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Study ID

NCT06214208

Start date

Feb 19, 2024

Status verified date

Oct, 2025

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must agree to allow use of health information.
  • Participants should be 16 years old or older.
  • 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.
  • Objectively measurable spasticity in your legs.
  • Participants must inform the investigators if there is a change in medications during the study.
  • Participants must be able to follow instructions.
  • Participants must be able to communicate if pain or discomfort is experienced.

Exclusion Criteria:

  • People with spinal issues that are getting worse, such as degenerative or progressive vascular disorders.
  • People neurological problems other than SCI.
  • People with an injury level is below T12.
  • People with un-treated or uncontrolled heart problems that the lead investigator believes could be affected by stimulation or affected by an increase in blood pressure.
  • People with bone or joint problems that would make it hard to follow the study plan.
  • Women who are pregnant or actively trying to become pregnant.
  • People with implanted stimulators (like a baclofen pump, spinal stimulator, heart defibrillator, or diaphragmatic pacemaker)
  • People with infection.
  • People with skin that is broken or wounds in the area of the body where stimulation is applied.
  • People who have or had certain types of cancer in the area of the body where stimulation will be applied.
  • People who have had botulinum toxin or numbing shots in the test leg or spine in the last 6 months
  • People who have had permanent spasticity treatment in the test leg or spine (like a certain type of surgery).
  • Other health issues that the lead investigator things could make it unsafe for you to join the study.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 30 Hz Frequency

Intervention will be applied with a 30 Hz frequency.

experimental: 50 Hz Frequency

Intervention will be applied with a 50 Hz frequency.

experimental: 80 Hz Frequency

Intervention will be applied with an 80 Hz frequency.

Interventions

Transcutaneous Spinal Stimulation

Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic pulses. A single cathode electrode will be placed over the skin of the back spine at the T11/T12 spinous interspace. Two reference electrodes will be placed over the stomach. Stimulation intensity will be set to 0.8x reflex threshold, as determined by posterior root muscle reflex testing before the intervention. Treatments will be a minimum of 72 hours apart.

Primary outcome measure

  • Pendulum Test [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Jaclyn Miller, PT, DPT

404-350-7638jaclyn.miller@shepherd.org

Evan Sandler, PT, DPT

404-603-4175evan.sandler@shepherd.org

Locations

Shepherd Center, Inc.

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Jaclyn MIller, PT, DPT

(404) 350-7638jaclyn.miller@shepherd.org

Evan Sandler, PT, DPT

(404) 603-4175evan.sandler@Shepherd.org

More Information

Sponsor

Shepherd Center, Atlanta GA

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shepherd Center, Atlanta GA on 2025-10-30.