Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

NCT02899637 | Unknown DMC

• 1 other identifier: 18753713.0.0000.5187
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to conduct a study protocol to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on sensory and motor performance of individuals with incomplete spinal cord injury (iSCI) . A double-blind randomized sham-controlled trial of patients with iSCI will be conducted.

Conditions

Spinal Cord Injury

Keywords

Incomplete Spinal Cord Injury; Rehabilitation; Non-invasive brain stimulation; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to three weeks.

  The ASIA Motor Score is derived from part of the assessment for the International Standards for Neurological Classification of Spinal Cord Injury. It involves testing the strength of ten key muscles on each side of the body in the supine position (e.g., elbow flexors, wrist extensors, hip flexors, quadriceps, dorsiflexors) on a scale of 0 = no contraction to 5 = normal resistance through full range of motion. Scores are summed to give a total possible score of 50 for the upper extremities and 50 for the lower extremities.

  At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks.

Secondary Outcomes (3)

• American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in sensory scores from baseline to three weeks.sensory score.

  At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks.

• Fugl-Meyer Scale for Upper and Lower Members, Assessment of change in motor scores from baseline to three weeks.

  At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks.

• Electromyography (lower limbs), Assessment of change in motor function from baseline to three weeks.

  At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks.

Study Arms (2)

Spinal Cord Injury (Active Group)

EXPERIMENTAL

Active high-frequency Transcranial Magnetic Stimulation

Device: Active high-frequency Transcranial Magnetic Stimulation

Spinal Cord Injury (Control group)

SHAM COMPARATOR

Sham high-frequency Transcranial Magnetic Stimulation

Device: Sham high-frequency Transcranial Magnetic Stimulation

Interventions

Active high-frequency Transcranial Magnetic Stimulation DEVICE

Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week

Spinal Cord Injury (Active Group)

Sham high-frequency Transcranial Magnetic Stimulation DEVICE

Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week

Spinal Cord Injury (Control group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have a clinical diagnosis of iSCI with nonprogressive etiology
• Clinical stability
• Aged between 18-60 years old
• Score equal to 24 in the Mini-Mental State Examination
• No electroencephalography alterations
• Absence of depression assessed by Hamilton Depression Scale
• Currently receiving inpatient rehabilitation in Physiotherapy Health Center of University of the State of Paraiba, Brazil.

You may not qualify if:

• Have metal prosthesis in some part of the body
• Use cardiac pacemaker
• Present dementia or neurological disorders which can increase cortical excitability
• Have psychotic or schizophrenic disorders
• Take drugs that reduce seizure threshold or spasticity.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Universidade Estadual da Paraiba: collaborator

Study Sites (1)

Universidade Estadual da Paraiba

Campina Grande, Paraíba, 58429-500, Brazil

Location

Related Publications (13)

• Belci M, Catley M, Husain M, Frankel HL, Davey NJ. Magnetic brain stimulation can improve clinical outcome in incomplete spinal cord injured patients. Spinal Cord. 2004 Jul;42(7):417-9. doi: 10.1038/sj.sc.3101613.

  PMID: 15111994 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

• Bunday KL, Perez MA. Motor recovery after spinal cord injury enhanced by strengthening corticospinal synaptic transmission. Curr Biol. 2012 Dec 18;22(24):2355-61. doi: 10.1016/j.cub.2012.10.046. Epub 2012 Nov 29.

  PMID: 23200989 BACKGROUND

• Defrin R, Grunhaus L, Zamir D, Zeilig G. The effect of a series of repetitive transcranial magnetic stimulations of the motor cortex on central pain after spinal cord injury. Arch Phys Med Rehabil. 2007 Dec;88(12):1574-80. doi: 10.1016/j.apmr.2007.07.025.

  PMID: 18047871 BACKGROUND

• Jette F, Cote I, Meziane HB, Mercier C. Effect of single-session repetitive transcranial magnetic stimulation applied over the hand versus leg motor area on pain after spinal cord injury. Neurorehabil Neural Repair. 2013 Sep;27(7):636-43. doi: 10.1177/1545968313484810. Epub 2013 Apr 11.

  PMID: 23579183 BACKGROUND

• Kang BS, Shin HI, Bang MS. Effect of repetitive transcranial magnetic stimulation over the hand motor cortical area on central pain after spinal cord injury. Arch Phys Med Rehabil. 2009 Oct;90(10):1766-71. doi: 10.1016/j.apmr.2009.04.008.

  PMID: 19801069 BACKGROUND

• Kumru H, Murillo N, Samso JV, Valls-Sole J, Edwards D, Pelayo R, Valero-Cabre A, Tormos JM, Pascual-Leone A. Reduction of spasticity with repetitive transcranial magnetic stimulation in patients with spinal cord injury. Neurorehabil Neural Repair. 2010 Jun;24(5):435-41. doi: 10.1177/1545968309356095. Epub 2010 Jan 6.

  PMID: 20053952 BACKGROUND

• Kuppuswamy A, Balasubramaniam AV, Maksimovic R, Mathias CJ, Gall A, Craggs MD, Ellaway PH. Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. Clin Neurophysiol. 2011 Dec;122(12):2452-61. doi: 10.1016/j.clinph.2011.04.022. Epub 2011 May 19.

  PMID: 21600843 BACKGROUND

• Lammertse D, Tuszynski MH, Steeves JD, Curt A, Fawcett JW, Rask C, Ditunno JF, Fehlings MG, Guest JD, Ellaway PH, Kleitman N, Blight AR, Dobkin BH, Grossman R, Katoh H, Privat A, Kalichman M; International Campaign for Cures of Spinal Cord Injury Paralysis. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design. Spinal Cord. 2007 Mar;45(3):232-42. doi: 10.1038/sj.sc.3102010. Epub 2006 Dec 19.

  PMID: 17179970 BACKGROUND

• Oudega M, Perez MA. Corticospinal reorganization after spinal cord injury. J Physiol. 2012 Aug 15;590(16):3647-63. doi: 10.1113/jphysiol.2012.233189. Epub 2012 May 14.

  PMID: 22586214 BACKGROUND

• Tazoe T, Perez MA. Effects of repetitive transcranial magnetic stimulation on recovery of function after spinal cord injury. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S145-55. doi: 10.1016/j.apmr.2014.07.418. Epub 2014 Aug 29.

  PMID: 25175159 BACKGROUND

• Yilmaz B, Kesikburun S, Yasar E, Tan AK. The effect of repetitive transcranial magnetic stimulation on refractory neuropathic pain in spinal cord injury. J Spinal Cord Med. 2014 Jul;37(4):397-400. doi: 10.1179/2045772313Y.0000000172. Epub 2013 Nov 11.

  PMID: 24621025 BACKGROUND

• de Araujo AVL, Barbosa VRN, Galdino GS, Fregni F, Massetti T, Fontes SL, de Oliveira Silva D, da Silva TD, Monteiro CBM, Tonks J, Magalhaes FH. Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial. Trials. 2017 Nov 6;18(1):522. doi: 10.1186/s13063-017-2280-1.

  PMID: 29110687 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Fernando H Magalhaes, Ph.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Vitoria L Araujo

CONTACT

+55 (11) 971212653; amandavitooria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 14, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)