Recruiting

Non-invasive Brain Stimulation

Sponsor:

Western University, Canada

Code:

NCT05975606

Conditions

Incomplete Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

repetitive transcranial magnetic stimulation (rTMS)

functional electrical stimulation (FES) cycling

Study Details

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.

Conditions

Incomplete Spinal Cord Injury

Study ID

NCT05975606

Start date

Sep 19, 2023

Status verified date

Jul, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

14 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment group

Participants of this group will receive active rTMS along with real FES cycling.

sham comparator: Control group

Participants of this group will receive sham rTMS along with real FES cycling.

Interventions

repetitive transcranial magnetic stimulation (rTMS)

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

functional electrical stimulation (FES) cycling

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

Primary outcome measure

  • Time taken to complete the recruitment of 12 participants [ Time Frame: 8 weeks ]
  • Proportion of participants recruited from the total number screened [ Time Frame: 8 weeks ]
  • Number of sessions attended by each participant [ Time Frame: 8 weeks ]
  • Number of dropouts in each group [ Time Frame: 8 weeks ]
  • Willingness of participants to undergo therapy [ Time Frame: 8 weeks ]
  • Incidence of treatment-emergent adverse events [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Janelle Unger, PhD

+1-519-646-6100janelle.unger@uwo.ca

Siobhan Schabrun, BSc

+1-519-646-6100sschabru@uwo.ca

Locations

Parkwood Institute

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

Janelle Unger, PhD

+1-519-664-6100janelle.unger@uwo.ca

Siobhan Scharbun, BSc

+1-519-646-6100sschabru@uwo.ca

More Information

Sponsor

Western University, Canada

Last update posted

Apr 13, 2025

Last verified

Jul, 2024

Keywords

  • incomplete spinal cord injury
  • repetitive transcranial magnetic stimulation
  • functional electrical stimulation cycling
  • lower extremity function
  • walking speed
  • muscle strength
  • feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2025-04-13.