Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

NCT05975606 | Recruiting

• 1 other identifier: 122650
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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).

  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.

  8 weeks

Secondary Outcomes (9)

• Walking speed

  8 weeks

• Step length

  8 weeks

• Step width

  8 weeks

• Cadence

  8 weeks

• Timed Up and Go (TUG) test

  8 weeks

Other Outcomes (1)

• Global Rating of Change (GRC) scale

  8 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Device: functional electrical stimulation (FES) cycling

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

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

Treatment group

functional electrical stimulation (FES) cycling DEVICE

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

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Parkwood Institute

London, Ontario, N6C 0A7, Canada

RECRUITING

Related Publications (19)

• 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.

  PMID: 35857624 BACKGROUND

• 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.

  PMID: 21062296 BACKGROUND

• 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.

  PMID: 13740272 BACKGROUND

• 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.

  PMID: 21704781 BACKGROUND

• 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.

  PMID: 24094120 BACKGROUND

• BARRIA P, AGUILAR R, DS D, MORIS A, ANDRADE A, JM A. Instrumented gait analysis of stroke patients after FES-cycling therapy.

  BACKGROUND

• 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.

  PMID: 23459246 BACKGROUND

• 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.

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 34504284 BACKGROUND

• 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.

  PMID: 25437531 BACKGROUND

• 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.

  PMID: 23322551 BACKGROUND

• 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.

  PMID: 27469242 BACKGROUND

• 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.

  PMID: 11114775 BACKGROUND

• 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.

  PMID: 8090549 BACKGROUND

• 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.

  PMID: 24110942 BACKGROUND

• 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.

  PMID: 8291966 BACKGROUND

• 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.

  PMID: 30586670 BACKGROUND

• 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.

  PMID: 31227660 BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Siobhan Schabrun, PhD

  Western University, Canada

  STUDY DIRECTOR

Central Study Contacts

Janelle Unger, PhD

CONTACT

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

Siobhan Schabrun, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to their groups. Research assistant and physiotherapist who are responsible for conducting assessment sessions are also blinded to participants group. All the participants will be randomized to groups using opaque envelopes blocked by four and stratified by AIS score.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 4, 2023
• Study Start: September 19, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)