Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploring the Effect of Non-invasive Brain Stimulation Paired With Functional Electrical Stimulation to Improve Lower Extremity Function Following Incomplete Spinal Cord Injury

Conditions
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Incomplete Spinal Cord Injury

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation (rTMS)
* Device: functional electrical stimulation (FES) cycling


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Participants of this group will receive active rTMS along with real FES cycling. | Device: repetitive transcranial magnetic stimulation (rTMS)<br>* rTMS will be applied to primary motor cortex of the brain.<br>Device: functional electrical stimulation (FES) cycling<br>* FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.<br>|
| Sham Comparator: Control group<br>Participants of this group will receive sham rTMS along with real FES cycling. | Device: functional electrical stimulation (FES) cycling<br>* FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to complete the recruitment of 12 participants | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol. | 8 weeks | 
| Proportion of participants recruited from the total number screened | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol. | 8 weeks | 
| Number of sessions attended by each participant | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. | 8 weeks | 
| Number of dropouts in each group | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. | 8 weeks | 
| Willingness of participants to undergo therapy | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. The willingness of participation will be collected on an 11-point numerical rating scale with 'not at all willing' at 0, and 'very willing' at 10 (measured at baseline). | 8 weeks | 
| Incidence of treatment-emergent adverse events | This outcome will be evaluated through descriptive data. Safety will be presented as any adverse reaction reported on verbal questioning at each session. The number of participants reporting adverse reactions, and the duration and severity of the adverse reactions will be reported. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking speed | This instrumental outcome is collected using a pressure sensor gait mat. | 8 weeks | 
| Step length | This instrumental outcome is collected using a pressure sensor gait mat. | 8 weeks | 
| Step width | This instrumental outcome is collected using a pressure sensor gait mat. | 8 weeks | 
| Cadence | This instrumental outcome is collected using a pressure sensor gait mat. | 8 weeks | 
| Timed Up and Go (TUG) test | This instrumental outcome will be collected using Inertial Measurement Units (IMUs). | 8 weeks | 
| Sit-to-stand test | This instrumental outcome will be collected using Inertial Measurement Units (IMUs). | 8 weeks | 
| Postural sway test | This instrumental outcome will be collected using Inertial Measurement Units (IMUs). | 8 weeks | 
| Lower Extremity Motor Score (LEMS) | A blinded physiotherapist will be hired to collect this clinical outcome. Lower Extremity Motor Score is rated from 0 to 5* as follows: 0= Total paralysis Palpable or visible contraction Active movement, full range of motion (ROM) when gravity is eliminated Active movement, full ROM against gravity Active movement, full ROM against gravity, and moderate resistance in muscle-specific position (Normal) Active movement, full ROM against gravity, and full resistance in a muscle-specific position expected from a healthy person 5*= (Normal) Active movement, full ROM against gravity, and sufficient resistance to be considered normal if identified inhibiting factors (i.e., pain, disuse) were not present NT = Not testable (i.e., due to immobilization, sever pain that can prevent the grading of the patient, amputation of the limb, or contracture of >50% of the range of motion) Higher scores in this outcome mean better result. | 8 weeks | 
| Walking Index for Spinal Cord Injury (WISCI) II scale | A blinded physiotherapist will be hired to collect this clinical outcome. Walking Index for Spinal Cord Injury version II scale is rated from 0 to 20 with the higher scores showing better results. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incomplete spinal cord injury, repetitive transcranial magnetic stimulation, functional electrical stimulation cycling, lower extremity function, walking speed, muscle strength, feasibility