← Back to Search

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

Must not have

A known history of moderate to severe chronic pain other than pDN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of intervention, 24 hours post intervention, and 1 week post intervention

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of chronic pain that is moderate to severe, not including diabetic nerve pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of intervention, 24 hours post intervention, and 1 week post intervention

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

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

Primary study objectives

Change in PROMIS-29 v2.0 Profile

Secondary study objectives

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.

0 / 2Eligibility criteria met