rTMS for Neuropathy in Cancer Patients

Overseen By Sarah Prinsloo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antipsychotics

Disqualifiers: Brain metastases, Bipolar, Schizophrenia, Seizure, 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: 12

Duration: 2 weeks

56 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well repetitive transcranial magnetic stimulation (rTMS) works in improving neuropathy due to oxaliplatin chemotherapy in patients with stage I-IV cancer. rTMS is designed to change brain activity by introducing small magnetic impulses to the scalp that encourage the brain to change its activity.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take antipsychotic medications. If you are taking Tramadol, you must stop it 48 hours before starting the trial and not use it during the study.

What data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for neuropathy in cancer patients?

Research shows that rTMS can provide significant pain relief for patients with chronic pain from various causes, including neuropathic pain. Although the specific effectiveness for cancer-related neuropathy is not well-documented, studies have shown positive outcomes in similar conditions, suggesting potential benefits. ^{1 2 3 4 5}

Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) has been studied for safety in both healthy individuals and those with neuropsychiatric conditions. While it is generally considered safe, some side effects like cognitive changes and the rare risk of seizures have been noted. Safety guidelines have been established and updated over the years to minimize risks. ^{2 6 7 8 9}

How is rTMS treatment different from other treatments for neuropathy in cancer patients?

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 providing relief for chemotherapy-induced peripheral neuropathy, unlike traditional treatments that often focus on managing pain with medications. ^{10 11 12 13 14}

Research Team

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking stage I-IV cancer patients who've had oxaliplatin chemotherapy and suffer from moderate to severe neuropathy. They must be stable on pain meds, able to visit MD Anderson for sessions, have an ECOG status of 0-2, and their neuropathy should be at least 3 months old. Excluded are those with bipolar disorder or schizophrenia, brain implants or pacemakers not MRI safe, antipsychotic use, brain metastases or CNS disease, head injury history, known seizures, or drug withdrawal.

Inclusion Criteria

I am not planning to change my current pain medication.

I am willing to travel to MD Anderson for my treatment.

I experience moderate to severe nerve pain or tingling.

Exclusion Criteria

I am currently taking antipsychotic medication.

I do not have implants or devices that are unsafe for MRI, and I can stop Tramadol 48 hours before the study.

I have had a head injury, brain lesions, or seizures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo rTMS or sham rTMS over 30 minutes for 10 sessions over 10 business days

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

2 visits (in-person)

Treatment Details

Interventions

• Repetitive Transcranial Magnetic Stimulation

Trial Overview The study tests if rTMS can improve chemotherapy-induced neuropathy in cancer patients. It involves small magnetic pulses applied to the scalp aimed at altering brain activity. Participants will either receive this intervention or a sham (fake) treatment as part of the control group while continuing their usual care routines.

Participant Groups

Group I: Group I (rTMS) Experimental Treatment 3 Interventions

Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.

Group II: Group III (standard of care) Active Control 3 Interventions

Patients receive standard of care.

Group III: Group II (sham rTMS) Placebo Group 3 Interventions

Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.

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?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 34 patients with malignant neuropathic pain, 10 sessions of real repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex resulted in significant short-term pain relief compared to sham treatment, as measured by various pain and depression scales.

The pain relief effects from rTMS were observed to last for up to 15 days after treatment, indicating its potential as a therapeutic option for managing malignant neuropathic pain, although the benefits did not persist beyond one month.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in neuropathic pain secondary to malignancy: a randomized clinical trial. Khedr, EM., Kotb, HI., Mostafa, MG., 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]

Repetitive transcranial magnetic stimulation (rTMS) has not been thoroughly studied for side effects, with the main known risk being the acute production of seizures.

While tissue damage from rTMS is unlikely, there are concerns about potential cognitive effects and the possibility of long-term changes in brain function that have not yet been fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. Wassermann, EM.[2005]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

In a meta-analysis of 93 randomized controlled trials involving repetitive transcranial magnetic stimulation (TMS), the overall incidence of adverse events (AEs) was found to be higher in the active TMS group (29.3%) compared to the placebo group (13.6%), indicating a 2.60 times greater risk of experiencing AEs with active treatment.

Despite the higher incidence of AEs, TMS is considered a safe and well-tolerated intervention, with common side effects including headache and dizziness, highlighting the importance of recognizing nocebo effects in both clinical trials and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Nocebo Phenomena During Transcranial Magnetic Stimulation: A Systematic Review and Meta-Analysis of Placebo-Controlled Clinical Trials. Zis, P., Shafique, F., Hadjivassiliou, M., et al.[2022]

In a pilot study involving 28 patients with treatment-resistant depression (TRD), accelerated deep transcranial magnetic stimulation (adTMS) showed significant reductions in depression scores, with a 59% decrease in Hamilton Depression Rating Scale (HDRS) scores after 10 days and 62% after 15 days.

The treatment was found to be safe, with only 9% of patients discontinuing due to adverse events, and 38% to 42% of patients achieving remission, indicating that adTMS could provide rapid clinical benefits and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot investigation of accelerated deep transcranial magnetic stimulation protocols in treatment-resistant depression. Filipčić, I., Šimunović Filipčić, I., Sučić, S., et al.[2022]

References

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

Repetitive Transcranial Magnetic Stimulation for Neuropathic Pain on the Non-Motor Cortex: An Evidence Mapping of Systematic Reviews. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in neuropathic pain secondary to malignancy: a randomized clinical trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Navigated transcranial magnetic stimulation improves the treatment outcome in patients with brain tumors in motor eloquent locations. [2021]

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

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

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

A randomized controlled trial of 5 daily sessions and continuous trial of 4 weekly sessions of repetitive transcranial magnetic stimulation for neuropathic pain. [2022]

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

Side effects of repetitive transcranial magnetic stimulation. [2005]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

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

Safety, Tolerability, and Nocebo Phenomena During Transcranial Magnetic Stimulation: A Systematic Review and Meta-Analysis of Placebo-Controlled Clinical Trials. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

A pilot investigation of accelerated deep transcranial magnetic stimulation protocols in treatment-resistant depression. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for chemotherapy-induced peripheral neuropathy in multiple myeloma: A pilot study. [2023]

11. Scotland pubmed.ncbi.nlm.nih.gov

Pilot study of repetitive transcranial magnetic stimulation in patients with chemotherapy-induced peripheral neuropathy. [2020]

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

Cancer and Peripheral Nerve Disease. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Chemotherapy-induced peripheral neuropathy. [2019]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Chemotherapy-Induced Neuropathy and Diabetes: A Scoping Review. [2023]