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ACTIVE NOT RECRUITING
NCT03625752
NA

Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Sponsor: Case Western Reserve University

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.

Official title: Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2019-06-06

Completion Date

2026-05-07

Last Updated

2025-06-27

Healthy Volunteers

No

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.

Locations (2)

Ciro Ramos Estebanez

Chicago, Illinois, United States

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

Cleveland, Ohio, United States