An interventional study of High Dose Intervention-tsDCS and Low Dose Intervention-tsDCS in Spinal Cord Injuries, sponsored by University of Florida. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
Transcutaneous spinal direct current stimulation (tsDCS) is a mild, non-invasive approach to increase spinal excitation and modulate spinal reflexes. Although ample evidence suggests tsDCS could enhance the effect of locomotor rehabilitation, the efficacy of this combinatorial strategy has not been investigated in individuals with ISCI. Based on supportive evidence from our prior feasibility study, the investigators will examine initial efficacy and mechanistic changes from combined tsDCS and locomotor training (tsDCS+LT).
Specific aim 1: To determine the effect size and variance of response to combined tsDCS and LT to enable power analysis for a larger clinical trial. Participants (chronic, motor ISCI) will complete a double-blind, randomized parallel-group design study to examine the effects of tsDCS (20 sessions, 30 minutes, anodal, 2.5 mA) delivered concurrently with LT. Walking outcomes will be measured pre- and post-intervention to compare the effects of tsDCS+LT versus sham+LT. Primary outcomes will be changes in overground walking speed and endurance.
Specific aim 2: To test the hypothesis that tsDCS+LT increases spinal motor excitability and reflex modulation. Spinal excitability will be assessed by Hoffman reflex amplitudes. Reflex modulation will be assessed by normalized measures of reflex post-activation depression as well as by gait phase-dependent modulation.
This proposed clinical trial will utilize a double-blind, randomized parallel-group experimental design. Once screening is complete, individuals will be enrolled for approximately two months to complete all study procedures. Participants will be randomized to receive either the higher or lower (sham) dose of tsDCS. The intervention will consist of 20 sessions (5 weeks x 4 sessions/week) of LT with the assigned tsDCS dose.
All participants will complete assessments at three time points. Clinical assessments to characterize injury severity and baseline characteristics, biomechanical, electromyographic (EMG) and clinical assessments of walking function, and reflex testing will be completed pre-intervention and one to three days post-intervention. A follow-up assessment consisting of clinical walking and mobility function outcomes only will be reassessed two weeks post-intervention.
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This study's enrollment of 30 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
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Exclusion Criteria:
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
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
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
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 6
Plan to share: No
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