Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

NAActive, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 6, 2019

Primary Completion Date

May 1, 2026

Study Completion Date

May 7, 2026

Conditions
Diabetic NeuropathiesChronic Pain
Interventions
DEVICE

Active Comparator: Active tDCS + Active TUS

Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

DEVICE

Sham

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Trial Locations (2)

60612

Ciro Ramos Estebanez, Chicago

44106-1716

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit, Cleveland

All Listed Sponsors
collaborator

Highland Instruments, Inc.

INDUSTRY

lead

Case Western Reserve University

OTHER