Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI

NARecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2027

Conditions
Spinal Cord Injuries
Interventions
DEVICE

Transcutaneous Spinal Cord Stimulation

Non-invasive electrical stimulation of the spinal cord over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver 1ms pulses with 10kHz carrier frequency at 30 Hz, which has demonstrated autonomic recovery in our previous studies. The location of tSCS is predetermined (at T10 and T11 vertebral levels). The stimulation intensity will range from 10 to 200 mA and specific criteria will be followed to determine the optimal therapeutic stimulation.

DEVICE

Sham Stimulation

Non-invasive electrical stimulation of a lower extremity muscle group over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver sham stimulation. The intensity of electrical stimulation will be briefly ramped up to a level at which the participants report perceiving the stimulation (i.e., sensory threshold), then ramped down and turned off for the remainder of the intervention.

Trial Locations (1)

98195

RECRUITING

University of Washington, Seattle

All Listed Sponsors
collaborator

The Craig H. Neilsen Foundation

OTHER

lead

University of Washington

OTHER