48
Participants
Start Date
July 27, 2022
Primary Completion Date
May 31, 2026
Study Completion Date
May 31, 2026
2400 ThorS-MagNT Stimulations at 1Hz
The inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. 1 Hz ThorS-MagNT, one of 4 total trains is delivered over 5 minutes with 3-min rest intervals on both right and left sides (total 1200 pulses/side).
2400 ThorS-MagNT Stimulations at 10Hz
The inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. 10Hz ThorS-MagNT involves delivering one train of 100 pulses per minute with 50-second rest intervals over twelve minutes on both right and left sides (total 1200 pulses/side).
Sham Stimulations
The inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. Sham stimulations, one of 4 total trains is delivered over 5 minutes with 3-min rest intervals on both right and left sides (total 1200 pulses/side).
RECRUITING
Augusta University, Augusta
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
National Institutes of Health (NIH)
NIH
Medical University of South Carolina
OTHER