Magnetic Stimulation for Diabetic Neuropathy

N/A

Waitlist Available

Led By Aimee Nelson, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A diagnosis of diabetic neuropathy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately before intervention, immediately following intervention

Summary

This trial aims to see if a 4-week treatment of repetitive transcranial magnetic stimulation (rTMS) can help reduce neuropathy symptoms in people with diabetic neuropathy. They will use question

Who is the study for?

This trial is for individuals with diabetic neuropathy, which is nerve damage caused by diabetes. Participants should be willing to undergo various tests such as questionnaires, nerve assessments, sensory tests, blood flow measurements, and blood tests to monitor changes in their condition.

What is being tested?

The study is testing whether a 4-week treatment using repetitive transcranial magnetic stimulation (rTMS) can relieve symptoms of diabetic neuropathy. Some participants will receive the actual rTMS while others will get a sham treatment for comparison purposes.

What are the potential side effects?

Possible side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness or seizures; however these are generally rare and the procedure is considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with diabetic neuropathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately before intervention, immediately following intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately before intervention, immediately following intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before intervention, immediately following intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified Toronto Clinical Neuropathy Score

PROMIS-29 v2.0 Profile

Pain catastrophizing scale-EN-SF

+1 more

Secondary study objectives

Change in blood flow

Change in inflammation markers (IL-1B, IL-6, IL-10, TNF-α, TGF-β, CRP, SP, and BDNF)

Change in nerve conduction assessments

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group B (Active)Active Control1 Intervention

Participants in group B will take part in 4 weeks of treatment with 5 sessions per week. Each session will involve real repetitive transcranial magnetic stimulation (rTMS). rTMS will be delivered at 10 Hz, 2004 pulses targeting the leg representation of the primary motor cortex. rTMS will take approximately 11.5 minutes.

Group II: Group A (Sham)Placebo Group1 Intervention

Participants in group A will take part in 4 weeks of treatment with 5 sessions per week. Each session will involve sham repetitive transcranial magnetic stimulation (rTMS). Sham rTMS will be delivered at 10 Hz, 2004 pulses targeting the leg representation of the primary motor cortex. Participants will hear and experience the clicking but will not be provided with any stimulation. Sham rTMS will take approximately 11.5 minutes.

0 / 1Eligibility criteria met