Stimulation to Enhance Walking Post-SCI
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/8/2019 |
| Start Date: | March 2019 |
| End Date: | September 30, 2019 |
| Contact: | Emily Fox, PT, PhD |
| Email: | ejfox@phhp.ufl.edu |
| Phone: | 352-273-6117 |
Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotion After Spinal Cord Injury
This 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.
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.
The purpose of this 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 (Cross-sectional): 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.
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 (Cross-sectional): 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.
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 of the spine
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