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

NCT06214208 | Recruiting

• 2 other identifiers: 21113271R01HD101812-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pendulum Test

  During the pendulum test, the participant will be lying on a therapy mat with the lower leg hanging off the edge of the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. This test will be video recorded and the movement of the knee joint will be measured using software on the computer.

  15 minutes

Secondary Outcomes (8)

• Ankle Clonus Test

  15 minutes

• Muscle activation

  20 minutes

• Posterior root muscle reflexes

  25 minutes

• Nociception/Pain

  15 minutes

• Quality of Spasticity Questionnaire

  5 minutes

Study Arms (3)

30 Hz Frequency

EXPERIMENTAL

Intervention will be applied with a 30 Hz frequency.

Other: Transcutaneous Spinal Stimulation

50 Hz Frequency

EXPERIMENTAL

Intervention will be applied with a 50 Hz frequency.

Other: Transcutaneous Spinal Stimulation

80 Hz Frequency

EXPERIMENTAL

Intervention will be applied with an 80 Hz frequency.

Other: Transcutaneous Spinal Stimulation

Interventions

Transcutaneous Spinal Stimulation OTHER

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.

30 Hz Frequency; 50 Hz Frequency; 80 Hz Frequency

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Shepherd Center, Inc.

Atlanta, Georgia, 30309, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Edelle C Field-Fote, PT, PhD

  Shepherd Center, Atlanta GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaclyn Miller, PT, DPT

CONTACT

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

Evan Sandler, PT, DPT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: February 19, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)