Thoracic Neuromodulation for Diabetic Gastroparesis

PHASE1RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

July 27, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Diabetic Gastroparesis
Interventions
DEVICE

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).

DEVICE

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).

DEVICE

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).

Trial Locations (1)

30912

RECRUITING

Augusta University, Augusta

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Medical University of South Carolina

OTHER