Neuromodulation for Peripheral Neuropathy

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antipsychotics

Disqualifiers: CNS disease, Bipolar, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 23

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a non-invasive therapy called neurofeedback training, a type of neuromodulation, can help individuals with peripheral neuropathy manage their symptoms more effectively. Neurofeedback uses an EEG, which tracks brain waves, to teach individuals how to change their brain activity, potentially reducing pain and improving quality of life. Participants are divided into groups, with some receiving actual neurofeedback and others receiving a sham version for comparison. The trial seeks participants who have experienced neuropathic pain for at least three months due to chemotherapy and are managing breast cancer. As an unphased trial, this study offers participants the opportunity to explore a novel, non-invasive treatment option for managing neuropathic pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you do not change your pain medication regimen during the study. You cannot participate if you are taking antipsychotic medications.

What prior data suggests that neurofeedback training is safe for patients with peripheral neuropathy?

Research has shown that neurofeedback training is generally safe for managing pain, including chronic pain and related issues. This therapy uses brain wave measurements to teach individuals how to reduce their pain.

Non-invasive techniques like neurofeedback are safe and practical for conditions such as nerve pain caused by chemotherapy. They are well-tolerated, with few reports of serious side effects.

The FDA has already approved the equipment used for neurofeedback for other purposes, indicating its safety. Overall, neurofeedback training appears to be a safe option for those with nerve pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neurofeedback training for peripheral neuropathy because it offers a unique, non-invasive approach to managing pain and improving quality of life. Unlike standard treatments like pain medications or physical therapy, neurofeedback uses real-time brain activity monitoring to help patients train their brains to respond differently to pain. This technique could potentially reduce pain perception without the side effects associated with medication. Additionally, the personalized nature of neurofeedback allows for tailored treatment sessions, which may enhance its effectiveness for each individual.

What evidence suggests that neurofeedback training is effective for peripheral neuropathy?

Research has shown that neurofeedback training, which participants in this trial may receive, can help reduce symptoms of nerve damage, known as peripheral neuropathy. Studies have found that it may decrease pain levels and improve the quality of life for those with chronic pain. Some evidence suggests that people using neurofeedback may need less medication for their pain. Neurofeedback teaches people to change their brainwave patterns, helping them manage pain more effectively. Overall, neurofeedback is considered a safe and promising method for managing symptoms related to neuropathy. ^{3 4 5 6 7}

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 adults over 18 with pain from chemotherapy-induced peripheral neuropathy, who've had this pain for at least 3 months and rate it at least a 4 on a scale of 0-10. They must be off chemo for six months, not planning to change their pain meds during the study, able to understand English, sign consent, and follow the protocol. They can't join if they have certain mental health conditions, other causes of neuropathy, CNS disease or seizures.

Inclusion Criteria

Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements

No plans to change pain medication regimen during the course of the study

I am able to care for myself and perform daily activities.

Exclusion Criteria

I have been diagnosed with bipolar disorder or schizophrenia.

I do not have active brain metastases or severe brain disorders.

I am currently taking antipsychotic medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Tests

Participants complete questionnaires and undergo an EEG to measure brain activity

1 week

1 visit (in-person)

Treatment

Participants undergo neurofeedback training sessions, with a minimum of 2 sessions per week for up to 10 weeks

10 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completing questionnaires and undergoing an EEG

4 weeks

2 visits (in-person)

Optional Extension

Participants in Groups 2 or 3 may continue in the study for an additional 4 months if they agree to optional procedures

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback Training

Trial Overview The study tests neurofeedback training—a non-invasive therapy using EEG to measure brain waves—to see if patients can learn to alter their brain activity to reduce neuropathy perception and improve life quality. All participants will receive this investigational use of FDA-approved equipment either at MD Anderson or within a specific distance from it.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 2 Interventions

Seven questionnaires regarding symptoms and quality of life completed at baseline, at follow up, and again in one month. Participants receive EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month.

Group II: Neurofeedback Training Experimental Treatment 4 Interventions

Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. Participants asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback and again at the conclusion of the session. Participants complete assessments again at the end of treatment and 1 month (+/- 2 weeks) later. Participants undergo an EEG at baseline, during each neurofeedback session, and within 7 days of the conclusion of treatment. Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.

Group III: Sham Neurofeedback Training Placebo Group 4 Interventions

Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. Participants asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback and again at the conclusion of the session. Participants complete assessments again at the end of treatment and 1 month (+/- 2 weeks) later. Participants undergo an EEG at baseline, during each neurofeedback session, and within 7 days of the conclusion of treatment. Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Rising Tide Foundation

Collaborator

Trials

17

Recruited

6,200+

Published Research Related to This Trial

Spinal cord stimulation (SCS) has been shown to significantly reduce pain in patients with painful diabetic neuropathy (PDN), with low-frequency SCS providing 45% to 55% pain reduction for up to two years in small trials, and high-frequency SCS achieving 76% mean pain relief after six months in a larger study.

The studies indicated that SCS is a safe treatment option for PDN, with no unexpected safety issues reported, highlighting its potential as an effective alternative to standard pharmacological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. Strand, NH., Burkey, AR.[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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11104502/

Evaluating the effectiveness of neurofeedback in chronic pain ... Several studies report significant reductions on pain intensity, improved quality of life, and decreased reliance on medication following ...

2. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-9-2015-29e05

Neuromodulation for Peripheral Neuropathy A systematic review found that non-invasive neuromodulation techniques are generally safe for managing chemotherapy-induced peripheral neuropathy, suggesting ...

3. curetoday.com curetoday.com/view/neurofeedback-brain-training

Can Neurofeedback Brain Training Ease Neuropathy? This research suggests that neurofeedback may be a valuable approach to reduce neuropathy symptoms and their impact on daily activities.” The ...

4. link.springer.com link.springer.com/article/10.1007/s11357-025-01848-7

EEG neurofeedback for the treatment of neuropathic pain ... With repeated practice and training, neurofeedback aims to promote positive changes in brain functioning and help individuals achieve more ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5470539/

Randomized Controlled Trial of Neurofeedback on ... Randomized Controlled Trial of Neurofeedback on Chemotherapy-Induced Peripheral Neuropathy: A Pilot Study - PMC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7378966/

Neurofeedback for Pain Management: A Systematic Review The findings indicate that NF procedures have the potential for reducing pain and improving other related outcomes in individuals with chronic pain.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388922000321

Evaluating the safety, feasibility, and efficacy of non- ... Non-invasive neuromodulation techniques are safe and feasible for managing CIPN. Non-invasive central neuromodulation techniques showed promising efficacy.