Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

Incomplete Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975606
• Other study ID #: 122650
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Western University, Canada
• Contact: Janelle Unger, PhD
• Phone: +1-519 664-6100
• Email: janelle.unger[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 interventions alone.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Incomplete Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Parkwood Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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).

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Rating of Change (GRC) scale	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.	8 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Walking speed	This instrumental outcome is collected using a pressure sensor gait mat.	8 weeks
Secondary	Step length	This instrumental outcome is collected using a pressure sensor gait mat.	8 weeks
Secondary	Step width	This instrumental outcome is collected using a pressure sensor gait mat.	8 weeks
Secondary	Cadence	This instrumental outcome is collected using a pressure sensor gait mat.	8 weeks
Secondary	Timed Up and Go (TUG) test	This instrumental outcome will be collected using Inertial Measurement Units (IMUs).	8 weeks
Secondary	Sit-to-stand test	This instrumental outcome will be collected using Inertial Measurement Units (IMUs).	8 weeks
Secondary	Postural sway test	This instrumental outcome will be collected using Inertial Measurement Units (IMUs).	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks