Stimulation to Enhance Walking Post-SCI

Not Applicable

Completed

Conditions: SCI - Spinal Cord Injury
Incomplete Spinal Cord Injury

Interventions: Device: Soterix Medical tsDCS stimulator
Other: Locomotor training

Registration Number: NCT03702842

Lead Sponsor: University of Florida

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.

Detailed Description: The purpose of this pilot study is to investigate the effects of transcutaneous direct current stimulation (tsDCS) on locomotor function and rehabilitation outcomes in individuals with incomplete spinal cord injury (ISCI). tsDCS is a mild, non-invasive form of electrical stimulation that can alter spinal cord excitability.

Specific Aim 1: To test the hypothesis that tsDCS applied during walking will improve motor activation in adults with chronic ISCI. A random order, double blind cross-over study will be conducted across two test sessions to compare the immediate effects of two dosages of tsDCS during walking. To assess motor activation, the primary outcome measure will be lower extremity surface electromyography.

Specific Aim 2 (Interventional): To test the hypothesis that tsDCS applied during 16 sessions of locomotor training will improve functional walking outcomes. Participants will be randomized to receive 16 sessions of locomotor training with one of the two tsDCS dosages. The primary outcome is walking function as measured by standardized clinical tests of walking speed and endurance.

To address the aims of the study, the investigators will use a two-part study design. Following phone and in-person screenings and physician approval, individuals will provide informed consent to the study procedures. In the first part, participants will complete two separate testing sessions, presented in random order, that involve up to 30 minutes of tsDCS at one of two dosages levels while walking. The researchers will assess changes in motor activation before and at the end of the period of walking. For the second part, participants will be randomized to receive 16 sessions of locomotor training with one of the two dosages of tsDCS. Before and after the 16-session intervention (i.e., at baseline and post intervention), the study team will assess functional outcomes through standardized tests of walking speed and endurance.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Interventional effects: Lower dosage	Locomotor training	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.
Immediate effects	Soterix Medical tsDCS stimulator	All participants will complete 2 sessions of walking with tsDCS separated by at least 72 hours. The only difference between sessions will be the dosage of stimulation (higher or lower dosage tsDCS 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.
Interventional effects: Higher dosage	Locomotor training	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.
Interventional effects: Higher dosage	Soterix Medical tsDCS stimulator	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.
Interventional effects: Lower dosage	Soterix Medical tsDCS stimulator	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.

Primary Outcome Measures

Name	Time	Method
Change in 10-Meter Walk Test (Interventional)	Baseline; Week 4	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.
Change in Plantar Flexor Muscle Electromyogram Activation During Walking (Immediate Effects)	Baseline; 1 hour	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.

Secondary Outcome Measures

Name	Time	Method
Change in 6-Minute Walk Test (Interventional)	Baseline; Week 4	The 6-Minute Walk Test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.