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Device

Electrical Stimulation for Diabetic Neuropathy Pain

N/A

Recruiting

Led By Ciro Ramos Estebanez, 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, 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 not have

Use of carbamazepine within the past 6 months as self-reported.

Suffering from severe depression (with a PHQ 9 score of ≥ 10).

Timeline

Screening 3 days

Treatment Varies

Follow Up 8 weeks

Summary

This trial is testing whether a combination of two types of electrical stimulation can help relieve pain and improve function in people with diabetic neuropathy.

Who is the study for?

This trial is for people aged 40-80 with diabetic neuropathy pain in at least one foot, lasting over 6 months and resistant to common painkillers. Participants must have consistent pain levels and be able to give consent. Excluded are those with certain medical histories like severe head injuries, fainting spells, drug abuse, or metal brain implants.

What is being tested?

The study tests the combination of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) against a sham treatment to see if they can reduce pain and improve function in patients with diabetic neuropathic pain.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, dizziness, nausea or itching under the electrodes during tDCS; TUS might cause temporary skin redness or warmth.

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 over 6 months, with pain most days and it averages at least a 4 out of 10.

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My pain does not improve with common painkillers.

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 severe depression, with a PHQ 9 score of 10 or higher.

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

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

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I have had brain surgery.

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My pain levels change significantly over a week.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 8 weeks4 visits

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 days for screening, Varies for treatment, and 8 weeks 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 (VAS)

Secondary study objectives

4-choice reaction time

Adverse events

Pharmaceutical Preparations

+12 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Comparator: 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