Clinical trial NCT05975606: Non-invasive Brain Stimulation Paired With FES Cycling Post SCI
Official title: Exploring the Effect of Non-invasive Brain Stimulation Paired With Functional Electrical Stimulation to Improve Lower Extremity Function Following Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Keywords: incomplete spinal cord injury
repetitive transcranial magnetic stimulation
functional electrical stimulation cycling
lower extremity function
walking speed
muscle strength
feasibility
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This protocol involves two groups of participants: intervention group and control group. Intervention group will receive real rTMS and FES cycling and control group will receive sham rTMS and FES cycling. The results of these groups are then evaluated at several stages of the study.
Primary purpose: TREATMENT

Brief summary: This project is randomized controlled trial which will explore the effect of pairing repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling on lower extremity function in people with incomplete spinal cord injury and compare the effects to each one of these interventions alone.

Detailed description: Following a spinal cord injury, people often have decreased strength and balance in their legs, making it difficult to walk. To improve leg function in people with spinal cold injuries, the investigators can use electrical stimulation on muscles while participants are cycling to increase the muscle activation and nerve connections. Another way to improve the nerve connections to the muscles is by stimulating the brain directly. Previous research has looked at the effects of each of these treatments, but they have not been used together. In this study, the investigators will pair both electrical stimulation on the legs during cycling with brain stimulation or a sham brain stimulation to improve recovery and determine if using these methods together results in better outcomes, such as increased walking speed. Participants will attend training sessions for six weeks, twice per week. Each person will first receive the active or sham brain stimulation at the beginning of the session for 30 minutes and then they will receive the electrical stimulation on their legs while cycling for 60 minutes. Participants will be evaluated before the start of the treatment, in the middle of the study, at the final session, and again two weeks after the last session of the treatment. Assessments will include clinical tests of gait, balance, and strength. Inertial Measurement Units (IMU) and a pressure sensor gait mat will be used to evaluate the gait and balance parameters.

Eligibility criteria: Inclusion Criteria:

* adult
* having motor incomplete SCI with level C or D on the American Spinal Injury Association Impairment Scale (AIS) with the lesion at any level of the cord resulting from either traumatic or non-traumatic etiology who are at least one-year post-injury.
* having non-progressive SCI
* being able to walk independently for 10 meters without help from another person

Exclusion Criteria:

* other orthopedic or neurological implications that affect the lower extremity function
* contraindications to FES (e.g., implanted electronic devices, unhealed bone fractures, sever contractures, extreme osteoporosis or osteoarthritis)
* contraindications to rTMS (e.g., metal implants, history of seizure, cochlear implants)

Primary outcomes:
measure: Time taken to complete the recruitment of 12 participants
timeFrame: 8 weeks
measure: Proportion of participants recruited from the total number screened
timeFrame: 8 weeks
measure: Number of sessions attended by each participant
timeFrame: 8 weeks
measure: Number of dropouts in each group
timeFrame: 8 weeks
measure: Willingness of participants to undergo therapy
timeFrame: 8 weeks
measure: Incidence of treatment-emergent adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Walking speed
timeFrame: 8 weeks
measure: Step length
timeFrame: 8 weeks
measure: Step width
timeFrame: 8 weeks
measure: Cadence
timeFrame: 8 weeks
measure: Timed Up and Go (TUG) test
timeFrame: 8 weeks
measure: Sit-to-stand test
timeFrame: 8 weeks
measure: Postural sway test
timeFrame: 8 weeks
measure: Lower Extremity Motor Score (LEMS)
timeFrame: 8 weeks
measure: Walking Index for Spinal Cord Injury (WISCI) II scale
timeFrame: 8 weeks
Other outcomes:
measure: Global Rating of Change (GRC) scale
timeFrame: 8 weeks
Locations:
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Siobhan Schabrun, PhD
role: STUDY_DIRECTOR
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