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Zapping the brain to quiet diabetic nerve pain

NCT ID NCT03625752

Symptom relief Sponsor: Case Western Reserve University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether two non-invasive brain stimulation techniques—transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS)—can reduce chronic pain in people with diabetic neuropathy. Participants, aged 40 to 80 with foot pain lasting at least 6 months, will receive either active or sham stimulation over several sessions. The goal is to see if these methods can safely lower pain intensity and improve function without drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS)
What this could lead to
If it works, this could offer a drug-free way to ease chronic pain from diabetic neuropathy, improving daily life for many.
What could go wrong
This is a small, early-stage study with 60 participants, so results may not apply to everyone. The effects may be modest or temporary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able to provide informed consent to participate in the study. 2. Subjects between 40 to 80 years old. 3. 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). 4. 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. 5. Must have the ability to feel pain as self-reported. Exclusion Criteria: 1. Subject is pregnant. 2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices 3. History of alcohol or drug abuse within the past 6 months as self-reported. 4. Use of carbamazepine within the past 6 months as self-reported. 5. Suffering from severe depression (with a PHQ 9 score of ≥ 10). 6. History of neurological disorders as self-reported. 7. History of unexplained fainting spells as self-reported. 8. History of severe head injury resulting in more than a momentary loss of consciousness as self-reported. 9. History of neurosurgery as self-reported. 10. 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).

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pain Diabetic neuropathies

Contacts and locations

Locations

  • Ciro Ramos Estebanez

    Chicago, Illinois, 60612, United States

  • University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

    Cleveland, Ohio, 44106-1716, United States

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