Table 1 Trial characteristics based on WHO Trial Registration Data Set
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 |