Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05975606

Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Incomplete Spinal Cord Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

rTMS will be applied to primary motor cortex of the brain.

functional electrical stimulation (FES) cycling

Device

FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.

Primary outcomes

  1. Time taken to complete the recruitment of 12 participants

    Time frame: 8 weeks

    This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.

  2. Proportion of participants recruited from the total number screened

    Time frame: 8 weeks

    This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.

  3. Number of sessions attended by each participant

    Time frame: 8 weeks

    This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.

  4. Number of dropouts in each group

    Time frame: 8 weeks

    This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.

  5. Willingness of participants to undergo therapy

    Time frame: 8 weeks

    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).

  6. Incidence of treatment-emergent adverse events

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Walking speed

    Time frame: 8 weeks

    This instrumental outcome is collected using a pressure sensor gait mat.

  2. Step length

    Time frame: 8 weeks

    This instrumental outcome is collected using a pressure sensor gait mat.

  3. Step width

    Time frame: 8 weeks

    This instrumental outcome is collected using a pressure sensor gait mat.

  4. Cadence

    Time frame: 8 weeks

    This instrumental outcome is collected using a pressure sensor gait mat.

  5. Timed Up and Go (TUG) test

    Time frame: 8 weeks

    This instrumental outcome will be collected using Inertial Measurement Units (IMUs).

  6. Sit-to-stand test

    Time frame: 8 weeks

    This instrumental outcome will be collected using Inertial Measurement Units (IMUs).

  7. Postural sway test

    Time frame: 8 weeks

    This instrumental outcome will be collected using Inertial Measurement Units (IMUs).

  8. Lower Extremity Motor Score (LEMS)

    Time frame: 8 weeks

    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.

  9. Walking Index for Spinal Cord Injury (WISCI) II scale

    Time frame: 8 weeks

    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.

Other outcomes

  1. Global Rating of Change (GRC) scale

    Time frame: 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Janelle Unger, PhD

CONTACT

[email protected]

+1-519-646-6100 ext. 45789

Siobhan Schabrun, BSc

CONTACT

[email protected]

+1-519-646-6100

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.