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Non-invasive Brain Stimulation

Noninvasive Brain Stimulation for Diabetic Neuropathy

Phase 2
Recruiting
Led By Salim Hayek, MD PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Having diabetic neuropathic pain, involving at least 1 foot, as defined by International Association for the Study of Pain and meeting criteria detailed by the Toronto Diabetic Neuropathy Expert Group - 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 diabetic neuropathic pain, involving at least 1 foot, as defined by International Association for the Study of Pain and meeting criteria detailed by the Toronto Diabetic Neuropathy Expert Group - 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
Must not have
Use of carbamazepine within the past 6 months as self-reported.
Suffering from major depression (with a PHQ-9 score of ≥10).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

This trial is testing a new treatment called non-invasive brain stimulation (ESSTim) for people with pain from diabetic neuropathy. The treatment uses mild electrical signals to change how the brain processes pain. Researchers believe this could be more effective. Non-invasive brain stimulation techniques have been explored for their potential to reduce chronic pain by altering brain activity.

Who is the study for?
This trial is for adults with diabetic neuropathic pain in at least one foot, unresponsive to common painkillers, and have had this pain for over 6 months. Participants must not be pregnant, have metal in their head or implanted brain devices, a recent history of substance abuse, use of certain medications like carbamazepine, major depression, neurological disorders such as stroke or epilepsy, unexplained fainting spells, significant head injuries or neurosurgery.
What is being tested?
The study tests if non-invasive brain stimulation (ESSTim) can better manage chronic pain from diabetic neuropathy compared to a sham (fake treatment). It involves active transcranial direct current stimulation (tDCS) combined with ultrasound therapy (TUS), versus a placebo-like device without actual therapeutic effect.
What are the potential side effects?
Potential side effects may include discomfort at the site of stimulation on the scalp or skin irritation due to the device. There's also a small risk of headache or dizziness post-treatment. Since it's noninvasive and doesn't involve drugs, systemic side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had diabetic foot pain for at least 6 months, with pain most days.
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I have had diabetic foot pain for at least 6 months, with pain most days and a pain level of at least 4.
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My pain doesn't improve with regular painkillers like Tylenol or Ibuprofen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken carbamazepine in the last 6 months.
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I have major depression with a PHQ-9 score of 10 or higher.
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I have had a head injury that caused me to lose consciousness.
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I have had fainting spells that doctors couldn't explain.
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I have had brain surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in pain as measured by the Visual Analog Scale
Secondary study objectives
4-choice reaction time
Adverse events
American Pain Foundation Pain and Medication Diary
+15 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active tDCS + Active TUSActive Control1 Intervention
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Group II: ShamPlacebo Group1 Intervention
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Diabetic Neuropathy focus on modulating neural activity to reduce pain perception. Non-invasive brain stimulation (like ESSTim) aims to alter neural circuits to decrease pain signals. Pharmacologic treatments often include anticonvulsants (e.g., pregabalin) and antidepressants (e.g., duloxetine), which work by inhibiting pain pathways in the central nervous system. Additionally, non-drug treatments such as exercise and cognitive-behavioral therapy can help by enhancing endogenous pain control mechanisms. These treatments are crucial for Diabetic Neuropathy patients as they target both peripheral and central pain processes, offering a multi-faceted approach to pain management.

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
304 Previous Clinical Trials
246,971 Total Patients Enrolled
Highland Instruments, Inc.Industry Sponsor
10 Previous Clinical Trials
473 Total Patients Enrolled
Salim Hayek, MD PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center/ Case Western Reserve University
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Active tDCS + Active TUS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469074 — Phase 2
~23 spots leftby Sep 2025
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