Magnetic Stimulation for Diabetic Neuropathy

Overseen By Aimee Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Psychological diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether repetitive transcranial magnetic stimulation (rTMS) can reduce symptoms of diabetic neuropathy, a condition where diabetes causes nerve damage, often resulting in pain or numbness. Participants will receive either real magnetic stimulation or a sham (fake) treatment to determine any noticeable difference in symptom relief. The study uses simple tests and questionnaires to track changes during the four-week treatment period. Individuals with diabetic neuropathy who have no issues with magnetic treatments and can follow the study's process are suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for diabetic neuropathy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that repetitive transcranial magnetic stimulation is safe for individuals with diabetic neuropathy?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for treating nerve pain. In one study, participants experienced significantly less pain with rTMS compared to a placebo treatment, demonstrating its effectiveness. Another study found that targeting rTMS at the brain's motor area is very safe for treating nerve pain, with minimal side effects. These studies suggest that rTMS is well-tolerated and could be a promising option for individuals with diabetic nerve pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for diabetic neuropathy focus on managing symptoms with medications like pain relievers, antidepressants, or anticonvulsants. But repetitive transcranial magnetic stimulation (rTMS) works differently by targeting the brain's primary motor cortex with magnetic pulses. This non-invasive technique aims to modulate brain activity, potentially reducing pain and improving nerve function without the side effects often associated with drugs. Researchers are excited because rTMS offers a fresh approach that could provide relief more directly at the source of nerve dysfunction. Plus, its non-drug nature means it could be a safer alternative for those who can't tolerate standard medications.

What evidence suggests that repetitive transcranial magnetic stimulation might be an effective treatment for diabetic neuropathy?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can help reduce pain in people with diabetic nerve damage. Studies have found that high-frequency rTMS can significantly ease this type of pain. More treatment sessions tend to lead to better results, particularly in managing leg pain. Some research even suggests that this treatment can improve the overall quality of life for those with diabetic nerve pain. However, effects can vary, and some studies have noted a strong placebo effect. In this trial, participants will be divided into two groups: Group A will receive sham rTMS, while Group B will receive active rTMS. Overall, evidence supports rTMS as a promising option for reducing pain in diabetic neuropathy. ^{1 3 4 6 7}

Who Is on the Research Team?

Aimee Nelson, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with diabetic neuropathy.

Exclusion Criteria

Contraindications to transcranial magnetic stimulation

Known psychological diagnosis affecting comprehension

I am unable to take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive transcranial magnetic stimulation (rTMS) or sham rTMS for 4 weeks, with 5 sessions per week

4 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation

Trial Overview

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.

How Is the Trial Designed?

Group I: Group B (Active) Active Control 1 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 Group 1 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.

Repetitive Transcranial Magnetic Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Migraines

Approved in European Union as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Anxiety disorders

Approved in Canada as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

In a study of 80 patients with chronic central neuropathic pain, repetitive transcranial magnetic stimulation (rTMS) showed significant pain relief, with an average reduction of 28% after the first 4 sessions and a cumulative effect of 48% after 15 sessions over 12 months.

The treatment was safe, with over 1000 rTMS sessions administered without any adverse effects, indicating its potential as a long-term therapy for refractory central neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Guided Neuronavigated Repetitive Transcranial Magnetic Stimulation (rTMS) in Central Neuropathic Pain. Quesada, C., Pommier, B., Fauchon, C., et al.[2019]

In a study of 248 patients with painful diabetic peripheral neuropathy (PDPN) who had not responded adequately to at least two lines of medication, frequency rhythmic electromagnetic neural stimulation (FREMS) led to a significant reduction in pain, with 32.3% of patients achieving a 50% reduction in pain scores after one month and 35.1% after three months.

FREMS treatment also resulted in a notable decrease in the self-reported use of opiates by over 50%, suggesting it may provide a valuable alternative for pain management in PDPN patients who struggle with conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice. Imholz, B., Heijster, J., Tahrani, A., et al.[2023]

Painful diabetic neuropathy is a common and costly issue for people with diabetes, often linked to poor glycemic control, but current treatments are inadequate and lack a mechanistically-based approach.

New neuromodulation devices have been recently approved by the FDA as potential next-line therapies for painful diabetic neuropathy, offering hope for patients who do not respond to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Painful Diabetic Neuropathy: The Need for New Approaches. Yeung, AM., Huang, J., Nguyen, KT., et al.[2022]

In a preliminary study involving four patients with relapsed major depressive disorder, rapid transcranial magnetic stimulation (rTMS) showed significant improvement in depression ratings after treatment.

The results indicated that rTMS can be effectively used again in patients who had previously responded well to this therapy, suggesting its potential for repeated use in managing relapsed depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation is effective in the treatment of relapse of depression. Dannon, PN., Schreiber, S., Dolberg, OT., et al.[2022]

Diabetic neuropathy significantly impacts patients' quality of life and is linked to serious complications like foot ulcers and increased mortality, highlighting the need for effective drug treatments.

Randomized clinical trials (RCTs) evaluating treatments for diabetic neuropathy have historically been of poor quality, emphasizing the importance of well-designed studies that consider factors like neuropathy stage, outcome measures, and long-term effects to ensure meaningful results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials for drugs against diabetic neuropathy: can we combine scientific needs with clinical practicalities? Ziegler, D., Luft, D.[2019]

Deep repetitive transcranial magnetic stimulation (rTMS) using the H-coil significantly reduced pain levels in patients with diabetic neuropathy, as evidenced by a decrease in visual analogue scale (VAS) scores and RIII reflex area after treatment.

The study involved 25 patients, with 23 completing the trial, and showed that the pain relief effects lasted for about 3 weeks post-treatment, indicating that deep rTMS can effectively target deeper brain areas to modulate pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

H-coil repetitive transcranial magnetic stimulation for pain relief in patients with diabetic neuropathy. Onesti, E., Gabriele, M., Cambieri, C., et al.[2022]

Citations

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Efficacy of Recurrent Transcutaneous Magnetic Stimulation in ...

In this two-arm trial, TCMS failed to demonstrate a significant benefit over sham in patient reported pain suggesting a substantial placebo effect.

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Effects of repetitive transcranial magnetic stimulation on ...

The results show that high-frequency rTMS can evidently relieve NP, and multiple sessions of stimulus can produce greater therapeutic effect.

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Repetitive TMS in treatment of resistant diabetic neuropathic ...

The aim of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving resistant chronic diabetic neuropathic ...

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painphysicianjournal.com/current/pdf?article=NzQyNw%3D%3D&journal=142

Short-term Effect of Repetitive Transcranial Magnetic ...

Conclusion: High-frequency rTMS on the left M1 may be useful for managing pain in the lower extremities due to DPN and may improve a patient's the quality of ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34196698/

a randomized multicentre sham-controlled trial

Our results support the clinical relevance of M1-rTMS, but not of DLPFC-rTMS, for peripheral neuropathic pain with an excellent safety profile.

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e-hpr.org

e-hpr.org/journal/view.php?number=917

Efficacy and Safety of Repetitive Transcranial Magnetic ...

Meta-analysis showed significant pain reduction with rTMS compared to sham treatment. At 2 weeks post-treatment, the mean pain score difference ...