Clinical trial NCT05429736: Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
Official title: SCIMS Site Specific Project: Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Spasticity, Muscle
Keywords: spinal
cord
incomplete
motor
skill
training
transcutaneous
stimulation
TSS
tSCS
electrophysiology
Lead sponsor: Shepherd Center, Atlanta GA
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2022-06-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive spinal stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training (MST) with transcutaneous spinal stimulation (TSS) may further enhance the restoration of function in persons with SCI. Therefore, the purpose of this study is to determine if moderate-intensity, MST can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive TSS will result in greater improvements in function compared to training alone.

Detailed description: Individuals with SCI will be asked to participate in this study over a four-week period. During the first 2 weeks (wash-in phase), individuals will participate in 6 aerobic and exercise training sessions as part of either an existing outpatient clinical program or by completing a personalized exercise plan. During the intervention phase (last 2 weeks), participants will be randomized to complete 6 training sessions of: 1) motor skill training combined with TSS (MST+TSS group) or 2) motor skill training combined with shamTSS (MST+shamTSS). All participants will complete 3 testing sessions: baseline testing 1 (prior the wash-in phase), testing 2 (after the completion of the wash-in phase and prior the intervention phase), and testing 3 (after the completion of the intervention phase) to assess their walking ability, balance, strength, and spasticity. During the intervention phase and to monitor within-session changes, participants will also complete a short version of walking function and balance assessments prior to and after each training session.

Eligibility criteria: Inclusion Criteria:

* Be 18-70 years of age
* Have a spinal cord injury (neurological level C3-T12) that occurred ≥3 months (sub-acute to chronic) prior to enrollment
* Have ISNCSCI severity classification C or D
* Able to stand for at least 5 minutes (with or without the aid of an assistive device)
* Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)
* Able to rise from sit to stand with moderate assistance from one person
* Use of prescription medication(s) for control of spasticity if the dosage has not changed in the last 2 weeks and you notify the study staff if your medication(s) change during study participation
* Ability and willingness to consent and authorize use of personal health information
* Ability to follow multiple instructions and communicate pain or discomfort

Exclusion Criteria:

* Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord
* Injuries below the neurological spinal level of T12
* Pregnant, or if you have reason to believe you are or may become pregnant due to unknown risks to the fetus associated with TSS
* History of cardiovascular irregularities
* Presence of orthopedic conditions that would adversely affect participation in exercise
* Implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g., baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, diaphragmatic pacemaker)
* Any cuts or sensitivity of the skin near the level of stimulation
* Active cancer or history of cancer
* Inability and unwillingness to consent and authorize use of personal health information

Primary outcomes:
measure: Change in 10 Meter Walk Test
timeFrame: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Secondary outcomes:
measure: Change of Spatiotemporal Gait Characteristic (Cadence)
timeFrame: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
measure: Change of Spatiotemporal Gait Characteristic (Stride Length - Both Lower Extremities)
timeFrame: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
measure: Change of Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)
timeFrame: Testing 1(Day 1), Testing 2 (Day 12), Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
measure: Change of Berg Balance Scale
timeFrame: Testing 1 (Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
measure: Change of Falls Efficacy Scale-International Version (FES-I)
timeFrame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
measure: Change of Spinal Cord Assessment Tool for Spastic Reflexes
timeFrame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
measure: Change of Modified 5-Times Sit-to-Stand
timeFrame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
measure: Change of 2 Minute Walk Test
timeFrame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
measure: Change of Maximal Isometric Strength
timeFrame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
measure: Change of Torque vs Speed Production
timeFrame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
measure: Change of Modified Spinal Cord Injury Spasticity Evaluation Tool (modified SCI-SET)
timeFrame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
Study officials:
affiliation: Shepherd Center, Atlanta GA
name: Edelle C Field-Fote, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: