AMPLIFY Study: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After SCI

NCT05700942 | Active Not Recruiting FDA Device

• 1 other identifier: IRB202201350
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Locomotor training (LT) facilitates recovery of spinal locomotor networks after incomplete spinal cord injury (ISCI), but walking impairments persist. A limitation of LT is insufficient excitation of spinal locomotor circuits to induce neuroplastic recovery. Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive approach to increase spinal excitation and modulate spinal reflexes. The study will examine if tsDCS combined with LT enhances locomotor rehabilitation after ISCI.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

• Change in 10-Meter Walk Test (10MWT)

  Is a performance measure used to assess walking speed in meters per second over a short distance. 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 6, Week 8

• Change in 6-Minute Walk Test (6MWT)

  The distance that a patient should walk based on their height, weight, age, and gender. Performance assessment of walking endurance for 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.

  Baseline, Week 6, Week 8

• Change in H-Reflex Post Activation Depression

  Assessment that quantifies the appropriate reduction in motor response to repeated sensory inputs. Increased post-activation depression (reduced motor response as measured with electromyography) reflects improved spinal modulation and may reflect normalization of an overactive stretch reflex.

  Baseline, Week 6

• Change in H-Reflex Gait Phase Modulation

  Assessment that quantifies the appropriate modulation of motor response to sensory input across the gait cycle. Improved modulation may reflect improved spinal rhythmic output to permit improved walking function.

  Baseline, Week 6

Study Arms (2)

High Dose Intervention

EXPERIMENTAL

tsDCS will be delivered to the lumbar region of the spinal cord during LT using a commercially available stimulation unit (Soterix Medical, Inc., New York, NY). tsDCS electrodes are comprised of a 10x5 cm carbon rubber electrode encased in a saline-soaked sponge. The anode electrode will be placed on the skin over the spinal processes of the 11th and 12th thoracic vertebrae, and the two cathode electrodes will be placed on each side of the umbilicus. For the high dose group, a standard dosage of 30 continuous minutes of 2.5 mA stimulus will be used.

Device: High Dose Intervention-tsDCS

Low Dose Intervention

ACTIVE COMPARATOR

tsDCS will be delivered to the lumbar region of the spinal cord during LT using a commercially available stimulation unit (Soterix Medical, Inc., New York, NY). tsDCS electrodes are comprised of a 10x5 cm carbon rubber electrode encased in a saline-soaked sponge. The anode electrode will be placed on the skin over the spinal processes of the 11th and 12th thoracic vertebrae, and the two cathode electrodes will be placed on each side of the umbilicus. The low dose condition will use an identical montage and stimulation arrangement, except the stimulation will be delivered briefly at the beginning and end of the stimulation period (30 seconds) with a three-second ramp.

Device: Low Dose Intervention-tsDCS

Interventions

High Dose Intervention-tsDCS DEVICE

Subjects will receive a high dose tsDCS (2.5mA, 30 mins) LT (4x/week, 5 weeks)

Also known as: standardized locomotor training (LT)/ walking rehabilitation on treadmill and overground

High Dose Intervention

Low Dose Intervention-tsDCS DEVICE

Subjects will receive a low dose tsDCS (2.5mA, 30 mins) LT (4xweek/ 5 weeks)

Also known as: standardized locomotor training (LT)/ walking rehabilitation on treadmill and overground

Low Dose Intervention

Eligibility Criteria

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

You may qualify if:

• Adults 18 to 65 years of age
• Single chronic SCI for ≥ 1 year classified as neurologic level T12 or above based on the International Standards for the Neurological Classification of SCI67 and classified according to the American Spinal Injury Association Impairment Scale (AIS) as motor incomplete (AIS C or D) at initial screening
• Medical stability with clearance from physician
• Ability to walk 3 meters with or without devices, braces, or assistance of one person
• Ability 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 prior), 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 of the spine below the 8th thoracic vertebrae or in region of electrode placement
• Implanted cardiac pacemaker or baclofen pump

Sponsors & Collaborators

• University of Florida: lead
• Brooks Rehabilitation: collaborator
• The Craig H. Neilsen Foundation: 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

Study Officials

• Emily Fox, DPT, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Stratified randomization will be used to allocate participants to their treatment group (higher or lower dose of tsDCS)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: January 26, 2023
• Study Start: March 10, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)