Neurofeedback for Head and Neck Cancer Pain

Age: 18+

Sex: Any

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: 7

17 Participants Needed

Trial Summary

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 must not change your type of pain medication during the study. You cannot participate if you are taking antipsychotic medications.

What data supports the effectiveness of the treatment LORETA Neurofeedback Training for head and neck cancer pain?

An exploratory study found that LORETA Neurofeedback Training helped patients with head and neck cancer reduce their pain perception by allowing them to modify brain activity related to pain. Fourteen out of seventeen patients reported decreased pain after the training sessions. ^{1 2 3 4 5}

Is neurofeedback safe for humans?

Neurofeedback, including LORETA Neurofeedback Training, is generally considered safe as it is a noninvasive treatment that involves brain training. It has been used for various conditions, and no significant safety concerns have been reported in the studies available. ^{2 5 6 7 8}

How does LORETA Neurofeedback Training differ from other treatments for head and neck cancer pain?

LORETA Neurofeedback Training is unique because it allows patients to modify their brain wave activity to reduce pain perception, unlike traditional pain treatments that often rely on medications. This approach targets specific brain areas associated with pain, offering a non-drug alternative for managing pain in head and neck cancer patients. ^{2 9 10 11 12}

What is the purpose of this trial?

This pilot trial studies how well neurofeedback training works in decreasing acute radiotherapy-induced pain in patients with head and neck cancer. Neurofeedback training is a type of therapy that uses electroencephalograph and a computer software program to measure brain wave activity. Neurofeedback training may help teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life.

Research Team

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking individuals with head and neck cancer, who are about to start a 6-week radiotherapy course and currently have low pain levels. They must consent to the study's protocol and not plan on changing their pain medication during the study. Those with chronic pain, mental health conditions like bipolar disorder or schizophrenia, seizure disorders, or active brain diseases cannot participate.

Inclusion Criteria

My head or neck pain is 2 or less on a scale of 0 to 10.

I do not plan to change my pain medication during the study.

I am set to start a 6-week radiotherapy for my head or neck cancer.

Exclusion Criteria

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

I am currently taking antipsychotic medication.

I have chronic pain in my head or neck that requires painkillers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Patients undergo radiotherapy as part of their cancer treatment

6 weeks

Neurofeedback Training

Patients undergo neurofeedback training once per day, three times per week for up to 6 treatments

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• LORETA Neurofeedback Training

Trial Overview The trial is testing neurofeedback training—a therapy that uses brain wave activity measurements to potentially reduce acute pain caused by radiotherapy in head and neck cancer patients. Participants will learn how to alter their own brain waves to lessen pain perception.

Participant Groups

Group I: Supportive care (neurofeedback) Experimental Treatment 2 Interventions

Beginning at weeks 4 and 5 or 5 and 6 of radiotherapy, patients undergo neurofeedback training QID TIW for up to 6 treatments. Patients also complete questionnaires over 10 minutes at baseline and after neurofeedback training.

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

A tailored hatha yoga program for head and neck cancer survivors was found to be feasible, with high participant retention and satisfaction, and no adverse events reported during the 8-week intervention.

Preliminary efficacy data suggested that the yoga program may improve shoulder range of motion, reduce pain, and decrease anxiety in participants, indicating potential benefits for managing long-term treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Efficacy of Tailored Yoga in Survivors of Head and Neck Cancer: A Pilot Study. Adair, M., Murphy, B., Yarlagadda, S., et al.[2019]

A 6-month study involving 23 female breast cancer survivors showed that EEG biofeedback (neurofeedback) is feasible and can significantly improve cognitive impairment, fatigue, and psychological symptoms associated with postcancer cognitive impairment (PCCI).

Participants experienced strong improvements across multiple measures, including cognitive function and sleep quality, with results maintained even 4 weeks after the neurofeedback training, indicating its potential as a restorative intervention for PCCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of EEG biofeedback on reducing postcancer cognitive impairment. Alvarez, J., Meyer, FL., Granoff, DL., et al.[2022]

Neurofeedback is a noninvasive treatment that uses brainwave analysis to help patients with central nervous system issues, especially when traditional therapies like medication and psychotherapy are ineffective.

While there are many clinical case studies supporting the efficacy of neurofeedback, there is still a need for more controlled studies in peer-reviewed journals to further validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. Larsen, S., Sherlin, L.[2013]

Both meditation techniques—meditation with a coach and self-meditation with a CD—were effective in reducing anxiety, depression, and emotional distress in patients undergoing radiation therapy for head and neck cancer, as shown in a study of 28 patients over 12 weeks.

Self-meditation with a CD was found to be a more cost-effective option compared to meditation with a coach, making it a practical choice for patients facing high stress during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Types of Meditation on Patients' Psychosocial Responses During Radiation Therapy for Head and Neck Cancer. Boxleitner, G., Jolie, S., Shaffer, D., et al.[2017]

References

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

Feasibility and Preliminary Efficacy of Tailored Yoga in Survivors of Head and Neck Cancer: A Pilot Study. [2019]

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

Exploratory Study of Low Resolution Electromagnetic Tomography (LORETA) Real-Time Z-Score Feedback in the Treatment of Pain in Patients with Head and Neck Cancer. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Effects of neurofeedback training on the cervical movement of adults with forward head posture. [2022]

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

A Systematic Review of the Safety and Effect of Neurofeedback on Fatigue and Cognition. [2022]

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

Exploring the Use of Neurofeedback by Cancer Survivors: Results of Interviews with Neurofeedback Providers and Clients. [2022]

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

The effect of EEG biofeedback on reducing postcancer cognitive impairment. [2022]

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

Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]

8. Japan pubmed.ncbi.nlm.nih.gov

Effects of neurofeedback training on the brain wave of adults with forward head posture. [2020]

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

Types and causes of pain in cancer of the head and neck. [2019]

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

Neuropathic and nociceptive pain in head and neck cancer patients receiving radiation therapy. [2022]

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

Role of Manual Therapy for Neck Pain and Quality of Life in Head and Neck Cancer Survivors: A Systematic Review. [2022]

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

Comparison of Two Types of Meditation on Patients' Psychosocial Responses During Radiation Therapy for Head and Neck Cancer. [2017]