Non-invasive Brain Stimulation Paired With FES Cycling Post SCI
NCT ID: NCT05975606
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
14 participants
INTERVENTIONAL
2023-09-19
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
All the participants will be randomized to groups using opaque envelopes blocked by four and stratified by AIS score.
Study Groups
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Treatment group
Participants of this group will receive active rTMS along with real FES cycling.
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.
Control group
Participants of this group will receive sham rTMS along with real FES cycling.
functional electrical stimulation (FES) cycling
FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Western University, Canada
OTHER
Responsible Party
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Principal Investigators
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Siobhan Schabrun, PhD
Role: STUDY_DIRECTOR
Western University, Canada
Locations
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Parkwood Institute
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Qin 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.
REED 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.
Riggins 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.
Sadowsky 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.
BARRIA 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.
Fawaz 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.
Alexeeva 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.
Kumru 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.
Kumru 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.
Donaldson 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.
Sloan 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.
Mazzoleni S, Stampacchia G, Gerini A, Tombini T, Carrozza MC. FES-cycling training in spinal cord injured patients. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:5339-41. doi: 10.1109/EMBC.2013.6610755.
Waters RL, Adkins RH, Yakura JS, Sie I. Motor and sensory recovery following incomplete paraplegia. Arch Phys Med Rehabil. 1994 Jan;75(1):67-72.
Wang RY, Wang FY, Huang SF, Yang YR. High-frequency repetitive transcranial magnetic stimulation enhanced treadmill training effects on gait performance in individuals with chronic stroke: A double-blinded randomized controlled pilot trial. Gait Posture. 2019 Feb;68:382-387. doi: 10.1016/j.gaitpost.2018.12.023. Epub 2018 Dec 18.
Shariat A, Najafabadi MG, Ansari NN, Cleland JA, Singh MAF, Memari AH, Honarpishe R, Hakakzadeh A, Ghaffari MS, Naghdi S. The effects of cycling with and without functional electrical stimulation on lower limb dysfunction in patients post-stroke: A systematic review with meta-analysis. NeuroRehabilitation. 2019;44(3):389-412. doi: 10.3233/NRE-182671.
Other Identifiers
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122650
Identifier Type: -
Identifier Source: org_study_id
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