An interventional study of repetitive transcranial magnetic stimulation (rTMS) and functional electrical stimulation (FES) cycling in Incomplete Spinal Cord Injury, sponsored by Western University, Canada. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 14 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Western University, Canada is the lead sponsor of 221 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants of this group will receive active rTMS along with real FES cycling.
Device: repetitive transcranial magnetic stimulation (rTMS) · Device: functional electrical stimulation (FES) cycling
Participants of this group will receive sham rTMS along with real FES cycling.
Device: functional electrical stimulation (FES) cycling
rTMS will be applied to primary motor cortex of the brain.
FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 8 weeks
Walking speed
This instrumental outcome is collected using a pressure sensor gait mat.
Time frame: 8 weeks
Step length
This instrumental outcome is collected using a pressure sensor gait mat.
Time frame: 8 weeks
Step width
This instrumental outcome is collected using a pressure sensor gait mat.
Time frame: 8 weeks
Cadence
This instrumental outcome is collected using a pressure sensor gait mat.
Time frame: 8 weeks
Timed Up and Go (TUG) test
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
Time frame: 8 weeks
Sit-to-stand test
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
Time frame: 8 weeks
Postural sway test
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
Time frame: 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 1. Palpable or visible contraction 2. Active movement, full range of motion (ROM) when gravity is eliminated 3. Active movement, full ROM against gravity 4. Active movement, full ROM against gravity, and moderate resistance in muscle-specific position 5. (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.
Time frame: 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.
Time frame: 8 weeks
Global Rating of Change (GRC) scale
Evaluation of the participants' impact will be collected through a GRC questionnaire in each assessment session. Global Rating Scale will ask participants to rate their walking abilities and overall recovery of the lower limb function from the time that they began the treatment until now. This scale is rated from -7 to 7 as follows: * 7: A very great deal worse * 6: A great deal worse * 5: Quite a bit worse * 4: Moderately worse * 3: Somewhat worse * 2: A little bit worse * 1: A tiny bit worse (almost the same) 0: About the same * 1: A tiny bit better (almost the same) * 2: A little bit better * 3: Somewhat better * 4: Moderately better * 5: Quite a bit better * 6: A great deal better * 7: A very great deal better Higher scores in this outcome mean better results.
Time frame: 8 weeks
Plan to share: No — IPD of this study will not be shared with other researchers of other studies.
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Western University, Canada