Brain-Controlled Spinal Stimulation Therapy for Restoration of Walking After Incomplete Spinal Cord Injury (SCI)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University of Miami
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number of related neurological deterioration (LEMS)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this research is to test the effectiveness of a new therapy, called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS), for improving walking in people with an incomplete spinal cord injury (SCI).
Investigators
Matija Milosevic
Assistant Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old and no older than 70 years old at the time of enrollment.
- •Traumatic incomplete spinal cord injury (neurological level at or above T10 spinal cord level; Abbreviated Injury Scale (AIS) C or D impairment grade for group 1, 3 and 4 and AIS B, C or D impairment grade for group 2), who are more than 6 months post-injury.
- •Has detectable motor function in at least 2 muscles per side confirmed by voluntary Electromyography (EMG) or detectable tibialis anterior (TA) muscle motor evoked potentials (MEPs) at the baseline assessment.
- •Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months.
- •Could effectively walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support, with functional spasticity (by participant's self-report), functional range-of-motion of lower limb joints, and acceptable bone mass to enable body-weight support, confirmed by Dual-energy X-ray absorptiometry (DXA) scan.
Exclusion Criteria
- •Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
- •Has severe spasticity that could prevent stepping and walking function determined by the investigator.
- •Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
- •Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS).
- •Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
- •Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
- •Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS.
- •Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
- •Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale).
- •Has breakdown in skin area that will come into contact with electrodes.
Outcomes
Primary Outcomes
Number of related neurological deterioration (LEMS)
Time Frame: up to 12 months
Lower Extremity Motor Score (LEMS) to assess lower limb muscle function following the American Spinal Injury Association Impairment Scale (ASIA) guidelines. The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function).
Number of subjects that complete the study
Time Frame: up to 12 months
Safety will be determined by number of subjects that complete the study, as designed.
Walking function using 10 meter walk test (10MWT)
Time Frame: up to 12 months
This is a test of short-distance walking function. The subject will be asked to walk at a comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway. Time is measured in meters per seconds.
Number of treatment related incidence of adverse events (AEs)
Time Frame: up to 12 months
Safety will be reported as the incidence of treatment related AEs as assessed by the study doctor
Walking function using 6 minute walk test (6MWT)
Time Frame: up to 12 months
The object of the test is to walk as far as possible for 6 minutes. The subject will walk at a normal pace around a marked course for 6 minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a subject walks, the better their cardiovascular condition. Units are measured in meters.
Secondary Outcomes
- Mobility measured by Timed Up and Go (TUG) Test(up to 12 months.)
- Balance measured by the Berg Balance Scale (BBS)(up to 12 months.)
- Muscular spasticity measured by the Modified Ashworth Scale (MAS)(up to 12 months.)
- Independence as measured by Spinal Cord Independence Measure (SCIM III)(up to 12 months)
- Quality of Life measured by the Reintegration to Normal Living (RNL) questionnaires(up to 12 months)
- Muscular spasticity measured by the Pendulum Test(up to 12 months.)
- Walking assistance measured by the Walking Index for Spinal Cord Injury Scale (WISCI II)(up to 12 months)
- Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL)(up to 12 months)