Clinical trial NCT06406855: Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)
Official title: Brain-Controlled Spinal Stimulation Therapy for Restoration of Walking After Incomplete Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-05-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: Inclusion Criteria:

1. At least 18 years old and no older than 70 years old at the time of enrollment.
2. 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.
3. 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.
4. Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months.
5. 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:

1. Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
2. Has severe spasticity that could prevent stepping and walking function determined by the investigator.
3. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
4. Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS).
5. Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
6. Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
7. Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS.
8. Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
9. Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale).
10. Has breakdown in skin area that will come into contact with electrodes.
11. Individuals who require therapy or other care that could interfere with participation in the study.
12. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
13. Individuals with substance disorders, including alcoholism and drug abuse.
14. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
15. In the opinion of the investigators, the study is not safe or appropriate for the participant.

Primary outcomes:
measure: Number of related neurological deterioration (LEMS)
timeFrame: up to 12 months
measure: Number of treatment related incidence of adverse events (AEs)
timeFrame: up to 12 months
measure: Number of subjects that complete the study
timeFrame: up to 12 months
measure: Walking function using 10 meter walk test (10MWT)
timeFrame: up to 12 months
measure: Walking function using 6 minute walk test (6MWT)
timeFrame: up to 12 months
Secondary outcomes:
measure: Mobility measured by Timed Up and Go (TUG) Test
timeFrame: up to 12 months.
measure: Balance measured by the Berg Balance Scale (BBS)
timeFrame: up to 12 months.
measure: Muscular spasticity measured by the Modified Ashworth Scale (MAS)
timeFrame: up to 12 months.
measure: Muscular spasticity measured by the Pendulum Test
timeFrame: up to 12 months.
measure: Walking assistance measured by the Walking Index for Spinal Cord Injury Scale (WISCI II)
timeFrame: up to 12 months
measure: Independence as measured by Spinal Cord Independence Measure (SCIM III)
timeFrame: up to 12 months
measure: Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL)
timeFrame: up to 12 months
measure: Quality of Life measured by the Reintegration to Normal Living (RNL) questionnaires
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami - MSOM
name: Matija Milosevic, PhD
role: PRINCIPAL_INVESTIGATOR
References: