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

91 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn if using a type of non-invasive therapy called neurofeedback training can help teach patients with peripheral neuropathy how to change their own brain waves to lower their perception of neuropathy and help improve their overall quality of life. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. This is an investigational study. The equipment used for neurofeedback training is FDA approved and commercially available. Using neurofeedback equipment to teach patients ways to modify their own brain waves to lower the perception of symptoms and improve quality of life is considered investigational. Up to 99 participants over the age of 18 will take part in this study. All will be enrolled at MD Anderson.

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 data supports the effectiveness of the treatment Neurofeedback Training for Peripheral Neuropathy?

Research on neuromodulation, a similar approach to neurofeedback, shows promise in treating chronic neuropathic pain, as it has been effective in other pain conditions like painful diabetic neuropathy. This suggests that neurofeedback, which is a type of neuromodulation, might also help manage pain in peripheral neuropathy. ^{1 2 3 4 5}

Is neuromodulation safe for treating peripheral neuropathy?

A systematic review found that non-invasive neuromodulation techniques are generally safe for managing chemotherapy-induced peripheral neuropathy, suggesting they may also be safe for other types of peripheral neuropathy. ^{1 2 3 4 6}

How is Neurofeedback Training different from other treatments for peripheral neuropathy?

Neurofeedback Training is unique because it involves patients actively participating in their own therapy by learning to control their brain activity, unlike other treatments that may rely on medications or physical interventions. This approach is non-invasive and empowers patients to manage their symptoms through self-regulation. ^{2 6 7 8 9}

Research Team

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

My pain level is 4 or higher, or I have severe nerve pain.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

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

2. Turkey pubmed.ncbi.nlm.nih.gov

Inhibitory effects of biofeedback electrostimulation therapy on pain and cortisol levels in chronic neuropathic pain: A randomized-controlled trial. [2022]

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

Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. [2022]

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

The effect of sensory nerve stimulation on sensory nerve function in people with peripheral neuropathy associated with diabetes. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Electroacupuncture is not effective in chronic painful neuropathies. [2011]

6. Scotland pubmed.ncbi.nlm.nih.gov

Evaluating the safety, feasibility, and efficacy of non-invasive neuromodulation techniques in chemotherapy-induced peripheral neuropathy: A systematic review. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

EEG Correlates of Self-Managed Neurofeedback Treatment of Central Neuropathic Pain in Chronic Spinal Cord Injury. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Neurotrophins and peripheral neuropathies. [2021]

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

Peripheral Nerve Stimulation for the Management of Pediatric Neuropathic Pain. [2023]