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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial is testing a new pain treatment for people with diabetes.

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.Check my eligibility
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.See study design
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.
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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.
Select...
My pain doesn't improve with regular painkillers like Tylenol or Ibuprofen.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in pain as measured by the Visual Analog Scale
Secondary outcome measures
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).

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
246,502 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present cohort size for this research endeavor?

"Affirmative. Records located on clinicaltrials.gov indicate that this medical trial is currently recruiting test subjects, which started February 25th 2022 and was last revised July 20th 2022. 80 patients are required to be enrolled from 3 different sites."

Answered by AI

Is it possible to register for this clinical research study?

"This medical trial is enrolling 80 patients aged 40 to 80 with diabetic neuralgia. Essential criteria include: providing informed consent, experiencing pain in at least one foot for 6 months or more according to the Toronto Diabetic neuropathy Expert Group's standards, having an average VAS score of 4/10 and being unresponsive to common analgesics like Tylenol and Aspirin; along with the ability to self-report pain sensations."

Answered by AI

Are there still vacancies available for participants in this investigation?

"Per the records on clinicaltrials.gov, this experiment is actively registering participants. It was posted in late February 2022 and revised at the end of July that same year."

Answered by AI

Is eligibility for this experiment restricted to individuals under the age of 20?

"This medical trial will include those aged 40 and over, up to 80 years old."

Answered by AI

Has the FDA approved simultaneous use of both Active tDCS and Active TUS?

"Our assessment of the safety of Active tdcs + Active TUS is a 2, since there are preliminary data indicating its security but no research has been conducted to assess efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
New Jersey
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
University of Illinois Health/ University of Illinois at Chicago
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
Recent research and studies
clinicaltrials.govStudy
Noninvasive Brain Stimulation for Diabetic Neuropathic Pain
Ciro Ramos Estebanez 2022. "Noninvasive Brain Stimulation for Diabetic Neuropathic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05469074.
All > Nerve Pain > Diabetic Neuropathy
~26 spots leftby Apr 2025
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