Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity

NCT05429736 | Active Not Recruiting FDA Device

• 1 other identifier: 1842303
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive spinal stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training (MST) with transcutaneous spinal stimulation (TSS) may further enhance the restoration of function in persons with SCI. Therefore, the purpose of this study is to determine if moderate-intensity, MST can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive TSS will result in greater improvements in function compared to training alone.

Conditions

Incomplete Spinal Cord Injury; Spasticity, Muscle

Keywords

spinal; cord; incomplete; motor; skill; training; transcutaneous; stimulation; TSS; tSCS; electrophysiology

Outcome Measures

Primary Outcomes (1)

• Change in 10 Meter Walk Test

  Walking speed (as determined by the 10MWT) is the primary outcome measure for assessing walking function. Participants will complete 3 10MWT trials at each testing session, separated by 2 minutes of seated rest. The average walking speed of the 3 walks will be calculated and used in the analyses.

  Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)

Secondary Outcomes (11)

• Change of Spatiotemporal Gait Characteristic (Cadence)

  Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)

• Change of Spatiotemporal Gait Characteristic (Stride Length - Both Lower Extremities)

  Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)

• Change of Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)

  Testing 1(Day 1), Testing 2 (Day 12), Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)

• Change of Berg Balance Scale

  Testing 1 (Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)

• Change of Falls Efficacy Scale-International Version (FES-I)

  Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)

Study Arms (2)

MST + TSS

EXPERIMENTAL

Individuals will participate in 6 training sessions of MST combined with TSS.

Behavioral: Motor Skill Training (MST); Device: Transcutaneous Spinal Stimulation (TSS)

MST + ShamTSS

SHAM COMPARATOR

Individuals will participate in 6 training sessions of MST while receiving shamTSS.

Behavioral: Motor Skill Training (MST)

Interventions

Motor Skill Training (MST) BEHAVIORAL

During MST participants will perform a series of 6 motor skill exercises designed to challenge balance, lower extremity coordination, agility, and speed. Five of these activities will be performed while standing to promote upright control and one activity will be performed while seated (alternating toe-tapping) to provide opportunity for active recovery. Participants will perform each exercise for one minute each, until 4 cycles of the circuit have been completed (approximately 45 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). During MST, participants will wear a chest-worn heart rate monitor to ensure that the optimal HRR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.

MST + ShamTSS; MST + TSS

Transcutaneous Spinal Stimulation (TSS) DEVICE

TSS will be delivered using a commercially available neuromuscular electrical stimulator. The active electrode will be positioned directly over the spine at the T11/T12 spinous interspace, and the reference electrode will be positioned over the umbilicus. Stimulation intensity will be gradually increased until paresthesia of the lower legs and feet is achieved or to the highest level each participant can tolerate. Stimulation will be delivered for a total duration of 30 min after paresthesia/ maximum tolerability is reached.

Also known as: tSCS

MST + TSS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18-70 years of age
• Have a spinal cord injury (neurological level C3-T12) that occurred ≥3 months (sub-acute to chronic) prior to enrollment
• Have ISNCSCI severity classification C or D
• Able to stand for at least 5 minutes (with or without the aid of an assistive device)
• Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)
• Able to rise from sit to stand with moderate assistance from one person
• Use of prescription medication(s) for control of spasticity if the dosage has not changed in the last 2 weeks and you notify the study staff if your medication(s) change during study participation
• Ability and willingness to consent and authorize use of personal health information
• Ability to follow multiple instructions and communicate pain or discomfort

You may not qualify if:

• Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord
• Injuries below the neurological spinal level of T12
• Pregnant, or if you have reason to believe you are or may become pregnant due to unknown risks to the fetus associated with TSS
• History of cardiovascular irregularities
• Presence of orthopedic conditions that would adversely affect participation in exercise
• Implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g., baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, diaphragmatic pacemaker)
• Any cuts or sensitivity of the skin near the level of stimulation
• Active cancer or history of cancer
• Inability and unwillingness to consent and authorize use of personal health information

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Muscle Spasticity; Cone-Rod Dystrophies

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Edelle Field-Fote, PT, PhD

  Shepherd Center, Atlanta GA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: June 23, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)