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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.
Timeline
Screening 3 days
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have had diabetic foot pain for over 6 months, with pain most days and it averages at least a 4 out of 10.
Select...
My pain does not improve with common painkillers.

Timeline

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

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 (VAS)
Secondary outcome measures
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).

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
246,522 Total Patients Enrolled
Highland Instruments, Inc.Industry Sponsor
10 Previous Clinical Trials
493 Total Patients Enrolled
Ciro Ramos Estebanez, MD PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center/ Case Western Reserve University
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

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

Is this medical experiment accepting new participants?

"Yes, clinicaltrials.gov indicates that this experiment is presently recruiting participants; it was first posted on June 6th 2019 and the last update was made on March 16th 2022. Currently there are 60 spots open to be filled from 2 distinct sites."

Answered by AI

What type of individual is most suitable for participation in this experiment?

"Individuals aged between 40 and 80 years old with chronic pain can apply to be part of this medical trial, which is open for recruitment to a total of 60 participants."

Answered by AI

To what extent has the study been populated with participants?

"Affirmative. The details posted on clinicaltrials.gov suggest that this medical investigation, initially uploaded on June 6th 2019, is actively seeking participants. Approximately 60 people will be recruited from 2 separate sites."

Answered by AI

Is this trial open to participants aged over 45?

"This medical trial only accepts applicants between 40 and 80 years old. Alternatively, there are other clinical trials available for those under 18 (33) and over 65 (397)."

Answered by AI

Who else is applying?

What state do they live in?
Other
Indiana
Ohio
Illinois
What site did they apply to?
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
Ciro Ramos Estebanez
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
2
0

Why did patients apply to this trial?

Tired of the pain. I really need help please. Looking for reliable relief.
PatientReceived no prior treatments
Nothing works so far. I am trying anything. I am taking Lyrica and it's not doing it's job.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When will u call to see if I qualify?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Ciro Ramos Estebanez: < 24 hours
  2. University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain
Ciro Ramos Estebanez, MD., Ph.D. 2019. "Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03625752.
All > Nerve Pain > Diabetic Neuropathy
~1 spots leftby Jun 2024
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