Spinal Cord InjuryNCT02899637
Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury
A study testing Active high-frequency Transcranial Magnetic Stimulation in people with Spinal Cord Injury, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Active high-frequency Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2016to May 2017
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual da Paraiba
Campina Grande, Paraíba, 58429-500
About this study
Official title: Effects of High-Frequency Transcranial Magnetic Stimulation on Functional Performance of Subjects With Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial
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.
Read the detailed description
Effective rehabilitation programs for individuals with incomplete spinal cord injury (iSCI) are required either in the acute or in the post-acute care. Rehabilitation techniques based on protocols that selectively stimulate specific pathways along the central nervous system have been considered effective in enhancing neurologic recovery thereby improving functional abilities. The rationale relies on the assumption that the stimulation of the corticospinal tract, primary motor cortex, and spinal cord might induce neuronal reorganization of structures that are largely involved in the control of voluntary movements. In this line of reasoning, protocols involving repetitive transcranial magnetic stimulation (rTMS) have been found effective in enhancing corticospinal synaptic transmission, attenuating neuropathic pain, improving spasticity and sensorimotor function after iSCI. However, controversial findings have also been reported, as other studies showed unaltered central pain, as well as cortical excitability and sensorimotor function. The lack of consistent results is probably associated with differences in stimulation parameters, number of sessions, site of stimulation, chronicity and levels of injury, and outcome measurements of the previous studies. Thus, it is clear that there are remaining gaps in our knowledge and the development of new studies, preferably prospective fully double-blind placebo-controlled trials, is necessary to complement the current knowledge about the effects of rTMS in patients with iSCI.
- Conditions
- Spinal Cord Injury
- Being tested
- Active high-frequency Transcranial Magnetic Stimulation, Sham high-frequency Transcranial Magnetic Stimulation
- Keywords
- Incomplete Spinal Cord Injury, Rehabilitation, Non-invasive brain stimulation, Transcranial Magnetic Stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active high-frequency Transcranial Magnetic StimulationDevice
Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week
Sham high-frequency Transcranial Magnetic StimulationDevice
Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury (Active Group) | Experimental | Active high-frequency Transcranial Magnetic Stimulation Receives: Device: Active high-frequency Transcranial Magnetic Stimulation |
| Spinal Cord Injury (Control group) | Sham comparator | Sham high-frequency Transcranial Magnetic Stimulation Receives: Device: Sham high-frequency Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The ASIA Sensory score is also part of the assessment for the International Standard for Neurological Classification of Spinal Cord Injury. It involves testing pinprick and light touch sensation at key points representing each dermatome. Pin-prick and light-touch sensation of each dermatome is separately scored on a 3-point scale (0, 1 and 2). Scores will be summed to give a total possible score of 224 where a higher score indicates better sensation than a lower score.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual da Paraiba
- Responsible party
- Principal investigator, Fernando Henrique Magalhães, University of Sao Paulo
- Investigators
- Fernando H Magalhaes, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899637
- Sponsor's protocol ID
- 18753713.0.0000.5187
- Status last verified
- Sep 2016
- First submitted
- 25 Aug 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 15111994Benito 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 23459246Bunday 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.
PubMed 23200989Defrin 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.
PubMed 18047871Jette 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.
PubMed 23579183Kang 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.
PubMed 19801069Kumru 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.
PubMed 20053952Kuppuswamy 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.
PubMed 21600843Lammertse 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.
PubMed 17179970Oudega 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.
PubMed 22586214Tazoe 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.
PubMed 25175159Yilmaz 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.
PubMed 24621025de 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.
PubMed 29110687
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Frequency Transcranial Magnetic Stimulation on Functional Performance of Subjects With Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02899637
- Acronym / sponsor ID
- 18753713.0.0000.5187
- Conditions
- Spinal Cord Injury
- Keywords
- Incomplete Spinal Cord Injury, Rehabilitation, Non-invasive brain stimulation, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Estadual da Paraiba
- Study start
- Oct 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- 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.
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.
Detailed description
Effective rehabilitation programs for individuals with incomplete spinal cord injury (iSCI) are required either in the acute or in the post-acute care. Rehabilitation techniques based on protocols that selectively stimulate specific pathways along the central nervous system have been considered effective in enhancing neurologic recovery thereby improving functional abilities. The rationale relies on the assumption that the stimulation of the corticospinal tract, primary motor cortex, and spinal cord might induce neuronal reorganization of structures that are largely involved in the control of voluntary movements. In this line of reasoning, protocols involving repetitive transcranial magnetic stimulation (rTMS) have been found effective in enhancing corticospinal synaptic transmission, attenuating neuropathic pain, improving spasticity and sensorimotor function after iSCI. However, controversial findings have also been reported, as other studies showed unaltered central pain, as well as cortical excitability and sensorimotor function. The lack of consistent results is probably associated with differences in stimulation parameters, number of sessions, site of stimulation, chronicity and levels of injury, and outcome measurements of the previous studies. Thus, it is clear that there are remaining gaps in our knowledge and the development of new studies, preferably prospective fully double-blind placebo-controlled trials, is necessary to complement the current knowledge about the effects of rTMS in patients with iSCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury (Active Group) | Experimental | Device: Active high-frequency Transcranial Magnetic StimulationActive high-frequency Transcranial Magnetic Stimulation |
| Spinal Cord Injury (Control group) | Sham comparator | Device: Sham high-frequency Transcranial Magnetic StimulationSham high-frequency Transcranial Magnetic Stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Active high-frequency Transcranial Magnetic StimulationActive intervention, 5Hz on the lower limbs area of the motor cortex, during one week | Device | Spinal Cord Injury (Active Group) |
| Sham high-frequency Transcranial Magnetic StimulationSham intervention, 5Hz on the lower limbs area of the motor cortex, during one week | Device | Spinal Cord Injury (Control group) |
Primary outcome
American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to three weeks.
Time frame: 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.
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.
3 secondary outcomes
American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in sensory scores from baseline to three weeks.sensory score.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Background: PubMed 15111994Belci 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.
- 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.
- Background: PubMed 23200989Bunday 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.
- Background: PubMed 18047871Defrin 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.
- Background: PubMed 23579183Jette 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.
- Background: PubMed 19801069Kang 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.
- Background: PubMed 20053952Kumru 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.
- Background: PubMed 21600843Kuppuswamy 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.
- Background: PubMed 17179970Lammertse 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.
- Background: PubMed 22586214Oudega 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.
- Background: PubMed 25175159Tazoe 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.
- Background: PubMed 24621025Yilmaz 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.
- Individual participant dataSharing planned: No
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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.
Fernando H Magalhaes, Ph.D. principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active high-frequency Transcranial Magnetic Stimulation in people with Spinal Cord Injury, run by University of Sao Paulo at 1 site in Brazil.
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 7 inclusion and 5 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 14 Sep 2016. 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 Brazil. 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 Amanda Vitoria L Araujo (+55 (11) 971212653, amandavitooria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to three weeks. (time frame: 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.). 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 NCT02899637, which also lists 13 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 14 Sep 2016.