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Procedure

cTMS for Diabetic Neuropathy

N/A
Waitlist Available
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 painful diabetic neuropathy (pDN)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of intervention, 24 hours post intervention, and 1 week post intervention
Awards & highlights

Study Summary

This trial will assess the effects of cTMS, a non-invasive form of brain stimulation, on diabetic neuropathic pain. Previous research has shown that it can reduce pain, but only works for ~50% of patients. This trial has the potential to make transformative changes in pDN & improve pain relief.

Who is the study for?
This trial is for individuals with painful diabetic neuropathy (pDN), which causes burning or electric shock-like pain in limbs. Participants must have a pDN diagnosis and be able to understand the study. They can't join if they have other chronic pains, use opioids daily, have contraindications to TMS, or psychological issues affecting comprehension.Check my eligibility
What is being tested?
The trial tests a new form of brain stimulation called controlled Transcranial Magnetic Stimulation (cTMS) against a sham procedure over five days. It aims to see if cTMS can reduce pain and improve neurological function in people with pDN.See study design
What are the potential side effects?
While not specified for cTMS, common side effects of similar treatments may include discomfort at the stimulation site, headache, lightheadedness, or temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with painful diabetic neuropathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of intervention, 24 hours post intervention, and 1 week post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of intervention, 24 hours post intervention, and 1 week post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in PROMIS-29 v2.0 Profile
Secondary outcome measures
Change in Pain catastrophizing scale-EN-SF
Change in Patient Perceived Global Index of Change (PGIC)
Change in nerve conduction assessments
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active cTMSActive Control1 Intervention
Controlled Transcranial Magnetic Stimulation (cTMS) will be delivered at 10 Hz, 1500 pulses targeting the hand representation of the left primary motor cortex. cTMS delivery will require ~9 min to complete. This intervention will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.
Group II: Sham cTMSPlacebo Group1 Intervention
Sham cTMS will be delivered at as a placebo control. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active cTMS. This will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
891 Previous Clinical Trials
2,605,436 Total Patients Enrolled
St. Joseph's Healthcare HamiltonOTHER
197 Previous Clinical Trials
26,418 Total Patients Enrolled

Media Library

Active Controlled Transcranial Magnetic Stimulation (cTMS) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05937984 — N/A
Diabetic Neuropathy Research Study Groups: Sham cTMS, Active cTMS
Diabetic Neuropathy Clinical Trial 2023: Active Controlled Transcranial Magnetic Stimulation (cTMS) Highlights & Side Effects. Trial Name: NCT05937984 — N/A
Active Controlled Transcranial Magnetic Stimulation (cTMS) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05937984 — N/A
~12 spots leftby Dec 2024
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