Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

NCT03625752 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY20180314-2/20201584
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetic Neuropathies; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Changes in pain as measured by the Visual Analog Scale (VAS)

  The scale will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). Changes in VAS for Pain will be measured to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.

  Measured for approximately 3 months

Secondary Outcomes (15)

• Changes in the Verbal Rating Scale (VRS) for Pain

  Measured for approximately 3 months

• Changes in Conditional Pain Modulation

  Measured for approximately 3 months

• Changes in Visual Analog Scalefor Mood (VAMS)

  Measured for approximately 3 months

• Montreal Cognitive Assessment

  Measured for approximately 3 months

• 4-choice reaction time

  Measured for approximately 3 months

Study Arms (2)

Active Comparator: Active tDCS + Active TUS

ACTIVE COMPARATOR

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).

Device: Active Comparator: Active tDCS + Active TUS

Sham

SHAM COMPARATOR

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Device: Sham

Interventions

Active Comparator: Active tDCS + Active TUS DEVICE

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.

Active Comparator: Active tDCS + Active TUS

Sham DEVICE

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.

Sham

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent to participate in the study.
• Subjects between 40 to 80 years old.
• Having diabetic neuropathic pain, involving at least 1 foot, with existing pain for at least 6 months, and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 VAS scale).
• Having pain resistant to common analgesics and medications for first-line therapy of chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, Codeine, etc.
• Must have the ability to feel pain as self-reported.

You may not qualify if:

• Subject is pregnant.
• Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
• History of alcohol or drug abuse within the past 6 months as self-reported.
• Use of carbamazepine within the past 6 months as self-reported.
• Suffering from severe depression (with a PHQ 9 score of ≥ 10).
• History of neurological disorders as self-reported.
• History of unexplained fainting spells as self-reported.
• History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
• History of neurosurgery as self-reported.
• Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 VAS scale over the 1-week period of trial run-in).

Sponsors & Collaborators

• Case Western Reserve University: lead
• Highland Instruments, Inc.: collaborator

Study Sites (2)

Ciro Ramos Estebanez

Chicago, Illinois, 60612, United States

Location

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

Cleveland, Ohio, 44106-1716, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salim Hayek, MD PhD

  University Hospitals Cleveland Medical Center/ Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology faculty

Model Details: single-center, double-blinded, placebo controlled, randomized study.

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 10, 2018
• Study Start: June 6, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 7, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)