19 Participants Needed

Transcranial Magnetic Stimulation for Peripheral Neuropathy

(rTMS for CIPN Trial)

JE
NA
Overseen ByNewaj Abdullah, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Utah
Must be taking: Neuropathic medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to ease pain from chemotherapy-induced peripheral neuropathy using repetitive transcranial magnetic stimulation (rTMS). This non-invasive treatment uses magnetic fields to stimulate nerve cells in the brain. The researchers aim to determine if rTMS can reduce pain scores for individuals who developed neuropathic pain after certain cancer treatments. Women who have had breast or gynecologic cancer and continue to experience neuropathic pain despite medication may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new pain relief options.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of your current neuropathic pain medication for at least 6 weeks before joining. However, you might need to stop or adjust other pain medications, as determined by the study doctor. If you are on tricyclic antidepressants, you will need to lower the dose to 50 mg daily at least one week before starting the treatment.

What prior data suggests that transcranial magnetic stimulation is safe for treating peripheral neuropathy?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive treatment. Studies have found it well-tolerated for treating nerve pain. For instance, a review of several studies found that rTMS effectively reduced pain without causing significant side effects, especially compared to a placebo (a fake treatment). Additional research supports its safety when used on the motor cortex, the part of the brain controlling voluntary movements. Overall, many studies have used the treatment without reporting major negative effects. This suggests that rTMS is generally safe for people with nerve pain.12345

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive approach to treating peripheral neuropathy, unlike traditional medications that often focus on pain relief through oral drugs. TMS works by using magnetic fields to stimulate nerve cells in the brain, which may help modulate pain signals more directly. Researchers are excited about this treatment because it has the potential to offer relief without the side effects associated with medications like opioids and anticonvulsants. Additionally, TMS could provide an option for those who haven't found success with existing treatments.

What evidence suggests that transcranial magnetic stimulation is effective for peripheral neuropathy?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), which participants in this trial will receive, can effectively reduce nerve pain. Studies indicate that high-frequency rTMS on the primary motor cortex has helped relieve pain, particularly in patients with nerve pain from conditions affecting the peripheral nerves. In one study, 42% of patients who underwent multiple rTMS sessions reported a pain reduction of more than 30%. Additionally, more frequent rTMS sessions have been linked to even better pain relief. Overall, rTMS appears promising for easing pain related to conditions such as nerve damage from chemotherapy.13567

Are You a Good Fit for This Trial?

This trial is for breast and gynecologic cancer survivors who are experiencing pain from chemotherapy-induced peripheral neuropathy. Specific eligibility criteria details were not provided, so interested individuals should inquire further to determine if they qualify.

Inclusion Criteria

Score of 3 or more on the Douleur Neuropathique 4 (DN-4) questionnaire
Subjects of childbearing potential must agree to use a highly effective method of contraception
Able to provide informed consent and willing to sign an approved consent form
See 7 more

Exclusion Criteria

Presence of incompatible implantable devices for rTMS administration
Enrollment in another study impacting study participation or causing undue burden
I have nerve pain not caused by cancer treatments.
See 7 more

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) for chemotherapy-induced peripheral neuropathy

10 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Long-term follow-up

Participants are monitored for long-term safety and effectiveness

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Magnetic Stimulation
Trial Overview The study is testing repetitive transcranial magnetic stimulation (rTMS) to see if it can reduce pain scores in patients suffering from nerve pain due to past chemotherapy treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Repetitive Transcranial Magnetic Stimulation (rTMS) AdministrationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Citations

Application of Repetitive Transcranial Magnetic Stimulation in ...Current evidence supports the use of 10 Hz HF-rTMS of the primary motor cortex to reduce neuropathic pain, especially in patients with spinal cord injury, ...
Efficacy of Repetitive Transcranial Magnetic Stimulation ...High-frequency repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) has shown its efficacy to alleviate pain ...
Repetitive transcranial magnetic stimulation focusing on ...Reportedly, rTMS treatment is more effective for peripheral neuropathic pain than for central pain. Furthermore, in a recent RCT, the efficacy ...
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.
Effects of multiple transcranial magnetic stimulation ...Results. In total, 193 patients completed test period of 4 rTMS sessions and 42% of them reported a pain relief (PR) greater than 30% ...
Analgesic Effects of rTMS in Peripheral Neuropathic PainThis study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of magnetic transcranial stimulation of the motor cortex or prefrontal ...
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 ...
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