Stimulation to Enhance Walking Post-SCI

NCT03702842 | Completed Results FDA Device

• 3 other identifiers: IRB201801582 -N -ANIH/NICHD 5P2CHD08685OCR16206
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury. Following rehabilitation, individuals with ISCI often demonstrate improved walking function, but continue to have serious impairments that limit mobility, community participation and quality of life. Adjuvants to rehabilitation that increase spinal excitation during training may enhance its effectiveness. tsDCS is a non-invasive neuromodulation approach that uses a mild electrical current, applied over the skin of the low back, to alter the membrane potential of spinal neurons. tsDCS will be applied during locomotor training, a well-established rehabilitation strategy that promotes walking recovery. Locomotor training emphasizes repetitive and task-specific practice of coordinated walking, often with therapist assistance or cueing to promote high quality movement patterns. The study team will explore if tsDCS combined with locomotor training increases spinal excitation and thereby improves the effectiveness of walking rehabilitation.

Conditions

SCI - Spinal Cord Injury; Incomplete Spinal Cord Injury

Keywords

walking; locomotor training; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in 10-Meter Walk Test (Interventional)

  Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function.

  Baseline; Week 4

• Change in Plantar Flexor Muscle Electromyogram Activation During Walking (Immediate Effects)

  The change in normalized amplitude of muscle activation recorded from the right ankle plantar flexor muscles (soleus and gastrocnemius) will be reported. EMGs will be recorded during speed-matched trials during walking on a treadmill. The normalized mean activation during single limb stance will be quantified for each step and averaged. For each participant, the change in activation will be quantified by subtracting activation pre training from post-training activation. The mean change and standard deviation of change will be reported for each group.

  Baseline; 1 hour

Secondary Outcomes (1)

• Change in 6-Minute Walk Test (Interventional)

  Baseline; Week 4

Study Arms (4)

Immediate effects low dose tsDCS

EXPERIMENTAL

Participants will receive one session of walking with a lower dosage of stimulation using the Soterix Medical tsDCS stimulator. During each session, participants will be asked to walk for up to 30 minutes on a treadmill while the stimulation is delivered. Assessments will be completed before and after the bout of treadmill walking.

Device: Soterix Medical tsDCS stimulator; Other: Locomotor training

Immediate effects higher dose tsDCS

EXPERIMENTAL

Participants will receive one session of walking with a higher dosage of stimulation using the Soterix Medical tsDCS stimulator. During each session, participants will be asked to walk for up to 30 minutes on a treadmill while the stimulation is delivered. Assessments will be completed before and after the bout of treadmill walking.

Device: Soterix Medical tsDCS stimulator; Other: Locomotor training

Interventional effects: Lower dosage

EXPERIMENTAL

After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.

Device: Soterix Medical tsDCS stimulator; Other: Locomotor training

Interventional effects: Higher dosage

EXPERIMENTAL

After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.

Device: Soterix Medical tsDCS stimulator; Other: Locomotor training

Interventions

Soterix Medical tsDCS stimulator DEVICE

tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.

Immediate effects higher dose tsDCS; Immediate effects low dose tsDCS; Interventional effects: Higher dosage; Interventional effects: Lower dosage

Locomotor training OTHER

Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.

Immediate effects higher dose tsDCS; Immediate effects low dose tsDCS; Interventional effects: Higher dosage; Interventional effects: Lower dosage

Eligibility Criteria

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

You may qualify if:

• Single spinal cord injury (duration \>1 year) classified as neurologic level T12 or above based on the International Standards for the Neurologic Classification of Spinal Cord Injury, and classified on the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) as 'C' or 'D' motor incomplete
• Capable of ambulating 10 feet with or without the use of gait devices, braces, or the assistance of one person
• Medically stable with no acute illness or infection
• Able to provide informed consent

You may not qualify if:

• Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
• Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction (\<1 year), pulmonary infection or illness, renal disease, autonomic dysreflexia, infections, pain, heterotopic ossification
• Cognitive or communication impairments limiting communication with study staff or ability to provide informed consent
• Lower extremity joint contractures limiting the ability to stand upright and practice walking
• Skin lesions or wounds affecting participation in walking rehabilitation
• Acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking rehabilitation
• Severe spasticity or uncontrolled movements limiting participation in walking rehabilitation
• Body weight or height that is incompatible with safe use of a support harness and body weight support system
• Pain that limits walking or participation in walking rehabilitation
• Current participation in rehabilitation to address walking function
• Botox injections in lower extremity muscles affecting walking function within 4 months of study enrollment
• Legal blindness or severe visual impairment
• Known pregnancy
• Implanted metal hardware below the level of the 8th thoracic vertebrae

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Brooks Rehabilitation: collaborator

Study Sites (1)

Brooks Rehabilitation Hospital

Jacksonville, Florida, 32216, 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

Results Point of Contact

• Title: Emily J Fox, Research Associate Professor
• Organization: University of Florida

ejfox@phhp.ufl.edu

352-273-6085

Study Officials

• Emily Fox, PT, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized to receive either 16 sessions of locomotor training with lower or higher dosage tsDCS, but will be unaware of the stimulation dosage level.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 11, 2018
• Study Start: April 1, 2019
• Primary Completion: September 2, 2021
• Study Completion: September 5, 2022
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)