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Table 1 Trial characteristics based on WHO Trial Registration Data Set

From: Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial

Data category Trial information
Primary registry and trial identifying number ClinicalTrials.gov, ID: NCT02899637
Date of registration in primary registry 25 August 2016 on
Secondary identifying numbers Ethical Committee of Paraiba State University, under the number CAEE: 18753713.0.0000.5187
Source(s) of monetary or material support Foundation of Support for Research of São Paulo State - FAPESP #2015/13096-1 and Coordination for Higher Education Staff Development - CAPES. 
Primary sponsor University of Sao Paulo – USP
Secondary sponsor(s) NA
Contact for public queries FHM, AVLA
Contact for scientific queries FHM, AVLA
Public title Effects of transcranial magnetic stimulation on incomplete spinal cord injury
Scientific title Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial
Country of recruitment Brazil
Health condition(s) or problem(s) studied Spinal cord injury
Interventions High-frequency repetitive transcranial magnetic stimulation on the lower-limb area of the motor cortex, over one week (five consecutive sessions – once a day)
Key inclusion and exclusion criteria Inclusion criteria: clinical diagnosis of iSCI with non-progressive etiology; at least six months post iSCI; clinical stability; age range 18–60 years; satisfactory score in Scale of Mini-Mental State Examination (i.e. cut-off points of 13 for illiterates, 18 for low and middle school, and 26 for high school); no pathological alterations on electroencephalography; absence of depression as assessed by the Hamilton Depression Scale and receive sensorimotor conventional physiotherapy. Exclusion criteria: metal prosthesis in some part of the body; cardiac pacemaker; either cognitive impairment, psychotic, or either schizophrenic disorders; neuropsychiatric co-morbidity; drugs that reduce seizure threshold or spasticity
Study type Interventional allocation: randomized
Masking: double-blind
Assignment: crossover
Primary purpose: treatment
Date of first enrolment December 2017
Target sample size 20
Recruitment status Recruiting
Primary outcome(s) Change in motor scores from baseline to four weeks
Key secondary outcome(s) Assessment of change in sensory and spasticity scores from baseline to four weeks
  1. NA not available