55
Participants
Start Date
November 27, 2020
Primary Completion Date
November 30, 2024
Study Completion Date
November 28, 2024
Magnetic transcutaneous spinal cord stimulation
In the active group, non-invasive spinal cord stimulation will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (thoracic level T2-T3). The intensity of stimulation will represent 100% of the motor threshold, which is determined by abdominal muscle contractions, found from single pulses, gradually applied every 10 seconds until the onset of contractions. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hertz repeated at 5 Hertz. In total 1200 pulses will be applied for 3 minutes and 58 seconds.
Transcutaneous electrical nerve stimulation
"To create a sensation of muscle contraction and impression of active stimulation, both the placebo and active groups will be subjected to the sensory effect of transcutaneous electrical neurostimulation (TENS). The surface electrodes of TENS (model Neurodyn®️, Ibramed®️) will be placed in parallel at the height of the thoracic level T2-T3, with the following parameters: 80Hertz, 150ms, approximately at 60 miliampère.~In the placebo group, a coil will be allocated in the thoracic region T2-T3, however this coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, away from its field of view, to provide the idea from the sound stimulus that it is being stimulated."
RECRUITING
University of Sao Paulo, São Paulo
University of Sao Paulo General Hospital
OTHER