What side effects are associated with this type of intervention?

Common treatments for diabetic neuropathy that involve modulation of neural activity, such as non-invasive brain stimulation, transcranial magnetic stimulation (TMS), and noninvasive vagus nerve stimulation (nVNS), generally have mild side effects. For TMS, side effects may include a warm sensation, arm or hand numbness, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. There are no serious adverse events reported for these treatments. These side effects are typically mild and transient, making these therapies relatively safe options for managing diabetic neuropathy pain.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic neuropathy, focusing primarily on pain management. While specific approvals for non-invasive brain stimulation like ESSTim are not detailed, other neuromodulation techniques such as transcutaneous electrical nerve stimulation (TENS) have been explored. Additionally, medications like pregabalin and duloxetine are commonly used to manage neuropathic pain. These treatments aim to modulate neural activity to reduce pain perception, aligning with the goals of ESSTim.

What other types of research exist?

Promising alternatives to ESSTim for diabetic neuropathy include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which has shown efficacy in treating chronic pain conditions; 2) Spinal Cord Stimulation (SCS), which has been effective in managing chronic pain and neuropathy; and 3) Transcranial Magnetic Stimulation (TMS), which has demonstrated pain relief in migraine and may be beneficial for neuropathic pain. These alternatives have shown positive outcomes in clinical trials and are available for use.

← Back to Search

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.

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

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

Select...

I have had diabetic foot pain for at least 6 months, with pain most days.

Select...

I have had diabetic foot pain for at least 6 months, with pain most days and a pain level of at least 4.

Select...

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:

Select...

I have not taken carbamazepine in the last 6 months.

Select...

I have major depression with a PHQ-9 score of 10 or higher.

Select...

I have had a head injury that caused me to lose consciousness.

Select...

I have had fainting spells that doctors couldn't explain.

Select...

I have had brain surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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).

0 / 8Eligibility criteria met

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.