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Procedure

Group B (Active) 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before intervention, immediately following intervention
Awards & highlights

Summary

The aim of this study is to determine whether a 4-week treatment of repetitive transcranial magnetic stimulation (rTMS) can alleviate the symptoms of neuropathy in individuals with diabetic neuropathy. The study will involve using questionnaires, nerve assessments, sensory tests, blood flow measurements, and blood tests to monitor any changes in symptoms after the rTMS intervention.

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following intervention, 4 weeks after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following intervention, 4 weeks after 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.

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Who is running the clinical trial?

McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,613,235 Total Patients Enrolled
Aimee Nelson, PhDPrincipal InvestigatorMcMaster University
3 Previous Clinical Trials
84 Total Patients Enrolled
~13 spots leftby Sep 2025
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