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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for diabetic neuropathy?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can help relieve chronic neuropathic pain, including pain from diabetic neuropathy, by targeting specific areas of the brain involved in pain perception. Studies have found that using rTMS on the motor cortex can significantly reduce pain, making it a promising non-invasive treatment option. ^{1 2 3 4 5}

Is magnetic stimulation safe for treating diabetic neuropathy?

While specific safety data for magnetic stimulation in diabetic neuropathy isn't provided, similar treatments like transcutaneous frequency-modulated electromagnetic neural stimulation (FREMS) have been evaluated for safety in clinical trials, suggesting a general interest in ensuring these treatments are safe for humans. ^{6 7 8 9 10}

How is repetitive transcranial magnetic stimulation (rTMS) different from other treatments for diabetic neuropathy?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, potentially relieving pain by altering brain activity. Unlike other treatments, deep rTMS can target deeper brain areas, which may help with pain relief and nerve regeneration in diabetic neuropathy. ^{1 6 11 12 13}

What is the purpose of this trial?

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.

Research Team

Aimee Nelson, PhD

Principal Investigator

McMaster University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

H-coil repetitive transcranial magnetic stimulation for pain relief in patients with diabetic neuropathy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Robot-Guided Neuronavigated Repetitive Transcranial Magnetic Stimulation (rTMS) in Central Neuropathic Pain. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the primary motor cortex in management of chronic neuropathic pain: a systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation is effective in the treatment of relapse of depression. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Treating Chronic Neuropathic Pain: a Systematic Review. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Pulsed magnetic field treatment ameliorates the progression of peripheral neuropathy by modulating the neuronal oxidative stress, apoptosis and angiogenesis in a rat model of experimental diabetes. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Treatment-induced neuropathy of diabetes: an acute, iatrogenic complication of diabetes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Painful Diabetic Neuropathy: The Need for New Approaches. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice. [2023]

12. Poland pubmed.ncbi.nlm.nih.gov

[Motor-evoked potentials in patients with diabetes mellitus type 1]. [2015]

13. India pubmed.ncbi.nlm.nih.gov

Prospects for the application of transcranial magnetic stimulation in diabetic neuropathy. [2021]