Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity

Shepherd Center, Atlanta GA

Status: Enrolling

Conditions: Spasticity, Muscle; Incomplete Spinal Cord Injury

Treatments: Device: Transcutaneous Spinal Stimulation (TSS); Behavioral: Motor Skill Training (MST)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05429736

1842303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

MST + TSS

Experimental group

Description:

Individuals will participate in 6 training sessions of MST combined with TSS.

Treatment:

Behavioral: Motor Skill Training (MST)

Device: Transcutaneous Spinal Stimulation (TSS)

MST + ShamTSS

Sham Comparator group

Description:

Individuals will participate in 6 training sessions of MST while receiving shamTSS.

Treatment:

Behavioral: Motor Skill Training (MST)