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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in reducing nerve pain caused by oxaliplatin chemotherapy in cancer patients. rTMS uses gentle magnetic pulses on the head to alter brain activity and reduce pain. Participants will be divided into groups: some will receive real rTMS, others will undergo a sham (fake) version, and some will receive usual care. The trial seeks cancer patients who have experienced chemotherapy-related nerve pain for at least three months and are willing to travel to MD Anderson for treatment sessions. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

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 prior data suggests that rTMS is safe for cancer patients with neuropathy?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated. Studies have used rTMS to treat pain, including pain from chemotherapy, and results indicate it can safely reduce nerve pain, which arises from nerve damage.

One study found that applying rTMS to the primary motor cortex (the brain area controlling movement) did not cause significant negative effects. Another study also supported its safety, suggesting that rTMS can effectively manage pain in cancer patients.

Overall, rTMS appears to be a promising option for those dealing with nerve pain from chemotherapy, with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for neuropathy in cancer patients, like pain medications and physical therapy, focus on managing symptoms rather than addressing the underlying issues. Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, potentially offering a more targeted approach to reducing neuropathic pain. Unlike typical oral medications, rTMS is non-invasive and may have fewer side effects. Researchers are particularly excited about rTMS because it could offer faster relief and improve quality of life for patients who haven't found success with traditional treatments.

What evidence suggests that rTMS is effective for neuropathy in cancer patients?

This trial will compare the effects of repetitive transcranial magnetic stimulation (rTMS) with a sham procedure and standard care in cancer patients experiencing neuropathy. Studies have shown that rTMS can help people with nerve pain caused by chemotherapy. In one study, 80% of patients reported feeling less pain after rTMS treatment. Researchers have discovered that rTMS, which uses magnetic pulses to stimulate the brain, significantly reduces nerve-related pain. Strong evidence suggests that rTMS can help not only with pain from chemotherapy but also with other conditions like fibromyalgia. This makes rTMS a promising option for improving nerve pain in cancer patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 have had nerve pain symptoms for at least 3 months.

Exclusion Criteria

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

I am currently taking antipsychotic medication.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10617261/

Repetitive transcranial magnetic stimulation for chemotherapy ... Results: Following repetitive transcranial magnetic stimulation treatment, 24/30 (80.0%) patients reported a reduction in chemotherapy-induced ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06949618

Repetitive Transcranial Magnetic Stimulation in Cancer ... As a result, some researchers suggest that targeting the motor cortex in cancer patients could improve pain management. However, few studies have investigated ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763421005315

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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11751341/

Repetitive Transcranial Magnetic Stimulation: Is it an Effective ... There is substantial evidence indicating that rTMS can improve neuropathic pain, fibromyalgia, and complex regional pain syndrome type I (CRPS) ...

5. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=388856

ANZCTR - Registration Effectiveness of repetitive Transcranial Magnetic stimulation (rTMS) for pain from chemotherapy-induced peripheral neuropathy (CIPN) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07120100

Transcranial Magnetic Stimulation for Chemotherapy- ... The goal of this study is to evaluate the change in pain scores among patients with chemotherapy-induced peripheral neuropathy after receiving treatment ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9962564/

Application of Repetitive Transcranial Magnetic Stimulation in ... rTMS is a potentially effective and safe treatment of neuropathic pain. Current evidence supports the use of 10 Hz HF-rTMS of the primary motor cortex to reduce ...

8. nature.com nature.com/articles/s41598-024-62018-x

Repetitive transcranial magnetic stimulation focusing on ... This study aimed to evaluate the efficacy and safety of navigation-guided repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex