Incomplete Spinal Cord InjuryNCT05975606
Non-invasive Brain Stimulation Paired With FES Cycling Post SCI
A study testing repetitive transcranial magnetic stimulation (rTMS) and functional electrical stimulation (FES) cycling in people with Incomplete Spinal Cord Injury, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incomplete Spinal Cord Injury
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS) and functional electrical stimulation (FES) cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Parkwood Institute
London, Ontario, N6C 0A7
Janelle Unger, PhD, +1-519-664-6100 ext. 45789, janelle.unger@uwo.ca
Siobhan Scharbun, BSc, +1-519-646-6100, sschabru@uwo.ca
About this study
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
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.
Read the 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.
- Conditions
- Incomplete Spinal Cord Injury
- Being tested
- repetitive transcranial magnetic stimulation (rTMS), functional electrical stimulation (FES) cycling
- Keywords
- incomplete spinal cord injury, repetitive transcranial magnetic stimulation, functional electrical stimulation cycling, lower extremity function, walking speed, muscle strength, feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
rTMS will be applied to primary motor cortex of the brain.
functional electrical stimulation (FES) cyclingDevice
FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants of this group will receive active rTMS along with real FES cycling. Receives: Device: repetitive transcranial magnetic stimulation (rTMS); Device: functional electrical stimulation (FES) cycling |
| Control group | Sham comparator | Participants of this group will receive sham rTMS along with real FES cycling. Receives: Device: functional electrical stimulation (FES) cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 8 weeks
Secondary outcomes (9)
Walking speed
This instrumental outcome is collected using a pressure sensor gait mat.
Measured: 8 weeks
Step length
This instrumental outcome is collected using a pressure sensor gait mat.
Measured: 8 weeks
Step width
This instrumental outcome is collected using a pressure sensor gait mat.
Measured: 8 weeks
Cadence
This instrumental outcome is collected using a pressure sensor gait mat.
Measured: 8 weeks
Timed Up and Go (TUG) test
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
Measured: 8 weeks
Sit-to-stand test
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
Measured: 8 weeks
Postural sway test
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start19 Sep 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siobhan Schabrun, PhD, Study director, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975606
- Sponsor's protocol ID
- 122650
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD of this study will not be shared with other researchers of other studies.
Publications
Ding W, Hu S, Wang P, Kang H, Peng R, Dong Y, Li F. Spinal Cord Injury: The Global Incidence, Prevalence, and Disability From the Global Burden of Disease Study 2019. Spine (Phila Pa 1976). 2022 Nov 1;47(21):1532-1540. doi: 10.1097/BRS.0000000000004417. Epub 2022 Jun 30.
PubMed 35857624Qin W, Bauman WA, Cardozo C. Bone and muscle loss after spinal cord injury: organ interactions. Ann N Y Acad Sci. 2010 Nov;1211:66-84. doi: 10.1111/j.1749-6632.2010.05806.x.
PubMed 21062296REED WB, PIDGEON J, BECKER SW. Patients with spinal cord injury. Clinical cutaneous studies. Arch Dermatol. 1961 Mar;83:379-85. doi: 10.1001/archderm.1961.01580090029002. No abstract available.
PubMed 13740272Riggins MS, Kankipati P, Oyster ML, Cooper RA, Boninger ML. The relationship between quality of life and change in mobility 1 year postinjury in individuals with spinal cord injury. Arch Phys Med Rehabil. 2011 Jul;92(7):1027-33. doi: 10.1016/j.apmr.2011.02.010.
PubMed 21704781Sadowsky CL, Hammond ER, Strohl AB, Commean PK, Eby SA, Damiano DL, Wingert JR, Bae KT, McDonald JW 3rd. Lower extremity functional electrical stimulation cycling promotes physical and functional recovery in chronic spinal cord injury. J Spinal Cord Med. 2013 Nov;36(6):623-31. doi: 10.1179/2045772313Y.0000000101. Epub 2013 Mar 20.
PubMed 24094120BARRIA P, AGUILAR R, DS D, MORIS A, ANDRADE A, JM A. Instrumented gait analysis of stroke patients after FES-cycling therapy.
Benito J, Kumru H, Murillo N, Costa U, Medina J, Tormos JM, Pascual-Leone A, Vidal J. Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):106-12. doi: 10.1310/sci1802-106.
PubMed 23459246Fawaz S, Kamel F, El Yasaky A, El Shishtawy H, Genedy A, Awad RM, El Nabil L. The therapeutic application of functional electrical stimulation and transcranial magnetic stimulation in rehabilitation of the hand function in incomplete cervical spinal cord injury. Egyptian Rheumatology and Rehabilitation. 2019 Jan;46(1):21-6.
Shariat A, Hosseini L, Najafabadi MG, Cleland JA, Shaw BS, Shaw I. Functional Electrical Stimulation and Repetitive Transcranial Magnetic Stimulation for Neurorehabilitation in Patients Post Stroke: A Short Communication. Asian Journal of Sports Medicine. 2018 Dec 31;9(4).
Krogh S, Aagaard P, Jonsson AB, Figlewski K, Kasch H. Effects of repetitive transcranial magnetic stimulation on recovery in lower limb muscle strength and gait function following spinal cord injury: a randomized controlled trial. Spinal Cord. 2022 Feb;60(2):135-141. doi: 10.1038/s41393-021-00703-8. Epub 2021 Sep 9.
PubMed 34504284Alexeeva N, Calancie B. Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. J Spinal Cord Med. 2016;39(1):50-7. doi: 10.1179/2045772314Y.0000000279. Epub 2014 Dec 1.
PubMed 25437531Kumru H, Benito J, Murillo N, Valls-Sole J, Valles M, Lopez-Blazquez R, Costa U, Tormos JM, Pascual-Leone A, Vidal J. Effects of high-frequency repetitive transcranial magnetic stimulation on motor and gait improvement in incomplete spinal cord injury patients. Neurorehabil Neural Repair. 2013 Jun;27(5):421-9. doi: 10.1177/1545968312471901. Epub 2013 Jan 15.
PubMed 23322551Kumru H, Benito-Penalva J, Valls-Sole J, Murillo N, Tormos JM, Flores C, Vidal J. Placebo-controlled study of rTMS combined with Lokomat(R) gait training for treatment in subjects with motor incomplete spinal cord injury. Exp Brain Res. 2016 Dec;234(12):3447-3455. doi: 10.1007/s00221-016-4739-9. Epub 2016 Jul 28.
PubMed 27469242Donaldson N, Perkins TA, Fitzwater R, Wood DE, Middleton F. FES cycling may promote recovery of leg function after incomplete spinal cord injury. Spinal Cord. 2000 Nov;38(11):680-2. doi: 10.1038/sj.sc.3101072.
PubMed 11114775Sloan KE, Bremner LA, Byrne J, Day RE, Scull ER. Musculoskeletal effects of an electrical stimulation induced cycling programme in the spinal injured. Paraplegia. 1994 Jun;32(6):407-15. doi: 10.1038/sc.1994.67.
PubMed 8090549
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05975606
- Acronym / sponsor ID
- 122650
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS), Device: functional electrical stimulation (FES) cyclingParticipants of this group will receive active rTMS along with real FES cycling. |
| Control group | Sham comparator | Device: functional electrical stimulation (FES) cyclingParticipants of this group will receive sham rTMS along with real FES cycling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)rTMS will be applied to primary motor cortex of the brain. | Device | Treatment group |
| functional electrical stimulation (FES) cyclingFES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus. | Device | Control group, Treatment group |
Primary outcome
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.
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.
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.
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.
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).
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.
9 secondary outcomes
Walking speed
Time frame: 8 weeks
Step length
Time frame: 8 weeks
Step width
Time frame: 8 weeks
Cadence
Time frame: 8 weeks
Timed Up and Go (TUG) test
Time frame: 8 weeks
Sit-to-stand test
Time frame: 8 weeks
Postural sway test
Time frame: 8 weeks
Lower Extremity Motor Score (LEMS)
Time frame: 8 weeks
Walking Index for Spinal Cord Injury (WISCI) II scale
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 35857624Ding W, Hu S, Wang P, Kang H, Peng R, Dong Y, Li F. Spinal Cord Injury: The Global Incidence, Prevalence, and Disability From the Global Burden of Disease Study 2019. Spine (Phila Pa 1976). 2022 Nov 1;47(21):1532-1540. doi: 10.1097/BRS.0000000000004417. Epub 2022 Jun 30.
- Background: PubMed 21062296Qin W, Bauman WA, Cardozo C. Bone and muscle loss after spinal cord injury: organ interactions. Ann N Y Acad Sci. 2010 Nov;1211:66-84. doi: 10.1111/j.1749-6632.2010.05806.x.
- Background: PubMed 13740272REED WB, PIDGEON J, BECKER SW. Patients with spinal cord injury. Clinical cutaneous studies. Arch Dermatol. 1961 Mar;83:379-85. doi: 10.1001/archderm.1961.01580090029002. No abstract available.
- Background: PubMed 21704781Riggins MS, Kankipati P, Oyster ML, Cooper RA, Boninger ML. The relationship between quality of life and change in mobility 1 year postinjury in individuals with spinal cord injury. Arch Phys Med Rehabil. 2011 Jul;92(7):1027-33. doi: 10.1016/j.apmr.2011.02.010.
- Background: PubMed 24094120Sadowsky CL, Hammond ER, Strohl AB, Commean PK, Eby SA, Damiano DL, Wingert JR, Bae KT, McDonald JW 3rd. Lower extremity functional electrical stimulation cycling promotes physical and functional recovery in chronic spinal cord injury. J Spinal Cord Med. 2013 Nov;36(6):623-31. doi: 10.1179/2045772313Y.0000000101. Epub 2013 Mar 20.
- BackgroundBARRIA P, AGUILAR R, DS D, MORIS A, ANDRADE A, JM A. Instrumented gait analysis of stroke patients after FES-cycling therapy.
- Background: PubMed 23459246Benito J, Kumru H, Murillo N, Costa U, Medina J, Tormos JM, Pascual-Leone A, Vidal J. Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):106-12. doi: 10.1310/sci1802-106.
- BackgroundFawaz S, Kamel F, El Yasaky A, El Shishtawy H, Genedy A, Awad RM, El Nabil L. The therapeutic application of functional electrical stimulation and transcranial magnetic stimulation in rehabilitation of the hand function in incomplete cervical spinal cord injury. Egyptian Rheumatology and Rehabilitation. 2019 Jan;46(1):21-6.
- BackgroundShariat A, Hosseini L, Najafabadi MG, Cleland JA, Shaw BS, Shaw I. Functional Electrical Stimulation and Repetitive Transcranial Magnetic Stimulation for Neurorehabilitation in Patients Post Stroke: A Short Communication. Asian Journal of Sports Medicine. 2018 Dec 31;9(4).
- Background: PubMed 34504284Krogh S, Aagaard P, Jonsson AB, Figlewski K, Kasch H. Effects of repetitive transcranial magnetic stimulation on recovery in lower limb muscle strength and gait function following spinal cord injury: a randomized controlled trial. Spinal Cord. 2022 Feb;60(2):135-141. doi: 10.1038/s41393-021-00703-8. Epub 2021 Sep 9.
- Background: PubMed 25437531Alexeeva N, Calancie B. Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. J Spinal Cord Med. 2016;39(1):50-7. doi: 10.1179/2045772314Y.0000000279. Epub 2014 Dec 1.
- Background: PubMed 23322551Kumru H, Benito J, Murillo N, Valls-Sole J, Valles M, Lopez-Blazquez R, Costa U, Tormos JM, Pascual-Leone A, Vidal J. Effects of high-frequency repetitive transcranial magnetic stimulation on motor and gait improvement in incomplete spinal cord injury patients. Neurorehabil Neural Repair. 2013 Jun;27(5):421-9. doi: 10.1177/1545968312471901. Epub 2013 Jan 15.
- Individual participant dataSharing planned: No. IPD of this study will not be shared with other researchers of other studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siobhan Schabrun, PhD study director
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation (rTMS) and functional electrical stimulation (FES) cycling in people with Incomplete Spinal Cord Injury, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janelle Unger, PhD (+1-519-646-6100 ext. 45789, janelle.unger@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken to complete the recruitment of 12 participants (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975606, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.