Improving Walking After Spinal Cord Injury

NCT07223710 | Not Yet Recruiting Phase 1

• 2 other identifiers: STU00222004R03HD114768-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Locomotor recovery is one of the most important goals of individuals with spinal cord injury (SCI). Ambulatory deficits severely impact daily functions resulting in lower quality of life for people living with paralysis due to SCI. Although studies have shown that locomotor training improves locomotor function in people with chronic SCI, the benefits remain limited. Our overall hypothesis is that we can engage additional descending motor pathways, such as the reticulospinal tract (RST), to improve locomotor function in humans with chronic incomplete SCI. In this study we propose to test the effects of a novel intervention that uses repeated paired loud auditory and electrical stimulation of muscle afferents combined with locomotor training on walking speed and voluntary muscle strength.

Conditions

Spinal Cord Injury

Keywords

auditory stimulation; peripheral stimulation; locomotion training; descending motor tracts

Outcome Measures

Primary Outcomes (1)

• 10-meter walk test (10MWT)

  This standardized test assesses walking speed in meters per second over a short duration.

  baseline and day 12

Secondary Outcomes (6)

• Motor Evoked Potentials conditioned with Startle (MEP-LAS)

  Baseline and day 12

• Maximum Voluntary Contraction (MVC)

  Baseline and day 12

• Maximal motor response (M-max)

  Baseline and day 12

• StartReact response

  Baseline and day 12

• Spasticity

  Baseline and day 12

Study Arms (2)

Locomotor training + PAS

EXPERIMENTAL

This intervention uses repeated paired loud auditory and electrical stimulation of muscle afferents combined with locomotor training. Participants will exercise walking on a treadmill with body weight support as needed for 30 minutes a day at a moderate intensity. While walking, participants will receive brief loud auditory stimuli through headphones and short electrical pulses through of electrodes positioned on two points in the leg

Device: Paired Associative Stimulation; Behavioral: Locomotor Training

Locomotor training + SHAM

SHAM COMPARATOR

This sham intervention uses repeated paired soft auditory clicks and electrical stimulation of muscle afferents combined with locomotor training. Participants will exercise walking on a treadmill with body weight support as needed for 30 minutes a day at a moderate intensity. While walking, participants will receive brief auditory clicks through headphones and short electrical pulses through a pair of electrodes positioned on two points in the leg.

Behavioral: Locomotor Training; Device: Sham stimulation

Interventions

Paired Associative Stimulation DEVICE

This new intervention consists of locomotor training in combination with paired low-intensity electrical stimulation and stimulation of the reticulospinal tract through loud sounds. Participants will receive auditory stimulation (LAS, 110dB, 500Hz, 50ms) through headphones and electrical stimulation through a pair of electrodes with 2cm inter-electrode distance positioned on the motor point over the quadriceps and the tibialis anterior muscles bilaterally. The motor point will be identified as the position of the electrodes that elicits a small visible muscle twitch or muscle contraction upon palpation over the tendon with the minimum stimulation intensity. Stimuli will be delivered with a pulse duration of 200 microseconds and will be timed to arrive at the level of the brainstem \~7ms before auditory signals.

Also known as: PAS

Locomotor training + PAS

Locomotor Training BEHAVIORAL

Participants will walk on a treadmill with body-weight support (ZeroG, Aretech) in the range 0-70% as needed to prevent excessive knee flexion during stance phase or toe dragging during swing phase (Finch et al. 1991). Each session will last approximately 60-min and the duration of the treadmill training will be timed to be 30 min. Subjects will be encouraged to walk at a self-selected speed at or above 0.1m/s. Speed and body-weight support will be adjusted to achieve a perceived exertion score of 4-5 (Moderate) in the Borg scale (Borg 1982). Subjects will be allowed to rest as needed during the training sessions.

Locomotor training + PAS; Locomotor training + SHAM

Sham stimulation DEVICE

Participants will receive brief low-intensity auditory clicks (80dB, 500Hz, 50ms) through headphones and electrical stimulation through a pair of electrodes with 2cm inter-electrode distance positioned on the motor point over the quadriceps and the tibialis anterior muscles bilaterally. The motor point will be identified as the position of the electrodes that elicits a small visible muscle twitch or muscle contraction upon palpation over the tendon with the minimum stimulation intensity. Stimuli will be delivered with a pulse duration of 200 microseconds and will be timed to arrive at the level of the brainstem \~7ms before auditory signals.

Locomotor training + SHAM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of traumatic or non-traumatic SCI ≥ 6 months
• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) level at and above T10.
• American Spinal Injury Association AIS Grade C, or D
• Weakness in ankle dorsiflexors (LEMS\<=3) with the ability to perform a small voluntary ankle dorsiflexion (as detected by presence of voluntary EMG activity in the tibialis anterior) with at least one leg.
• Ability to tolerate standing position.
• Ability to walk at a minimum speed of 0.1 mile/hour on a treadmill with less than 70% body weight support.
• Requires use of assistive devices (KAFO, AFO, cane, walker) or body weight support for ambulation.
• Ability to complete the 10-Meter Walk Test.

You may not qualify if:

• Preceding uncontrolled medical conditions including pulmonary, cardiovascular or orthopedic disease that interfere with physical performance.
• Intolerance to physical activity.
• Severe cognitive impairment that precludes the ability to participate in any of the study procedures or give verbal consent.
• Any illness or condition that based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during the study.
• History of stroke resulting in sensory motor deficits.
• Pregnant women.
• Participation in a high-intensity locomotor training program in the last 6 months.
• Inability to detect somatosensory evoked potentials
• Metal implant in the head
• History of epilepsy

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

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

• Dalia De Santis, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia De Santis

CONTACT

312-238-7895; ddesantis@sralab.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: November 3, 2025
• Study Start: November 15, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The de-identified IPD will be shared indefinitely on DASH. The data will be available at the end of the study.

Locations

US (1)