Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments electroencephalography (eeg), questionnaires, neurotherapy
Sponsor M.D. Anderson Cancer Center
Start date March 2014
End date March 2017
Trial size 25 participants
Trial identifier NCT02543320, 2011-1102

Summary

The goal of this study is to learn how the brain processes pain and if using neurofeedback training can help teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants undergo a baseline EEG prior to starting radiotherapy and during each neurotherapy session as required by LORETA. Participants undergo neurotherapy once a day, three days a week, for a total of 6 treatments. Pain and symptom questionnaires completed at baseline, before each LORETA neurofeedback session, 1 week after completion of neurofeedback sessions, and at the end of radiotherapy.
electroencephalography (eeg) EEG
Participants undergo a baseline EEG prior to starting radiotherapy, and during each neurotherapy session.
questionnaires Surveys
Pain and symptom questionnaires completed at baseline, before each LORETA neurofeedback session, 1 week after completion of neurofeedback sessions, and at the end of radiotherapy.
neurotherapy
Participants undergo neurotherapy once a day, three days a week, for a total of 6 treatments over a two week time period, and during weeks 4 and 5 or 5 and 6 of radiotherapy, depending on when they start to experience pain of at least a 4 on a pain scale of 0-10 for three consecutive days. Neurofeedback training given in a video-game format.

Primary Outcomes

Measure
Changes in Brain Function Using EEG (Electroencephalography) and LORETA in Perceptions of Radiation-Induced Pain in Head and Neck Cancer Participants
time frame: Baseline, 1 week after completing LORETA neurofeedback

Secondary Outcomes

Measure
Effects of Individualized LORETA Z Score Neurofeedback Program on Perceptions of Radiation-Induced Pain in Head and Neck Cancer Participants by Brief Pain Inventory (BPI)
time frame: Baseline, 1 week after completing LORETA neurofeedback
Effects of Individualized LORETA Z Score Neurofeedback Program on Perceptions of Radiation-Induced Pain in Head and Neck Cancer Participants by the M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
time frame: Baseline, 1 week after completing LORETA neurofeedback
Effects of Individualized LORETA Z Score Neurofeedback Program on Perceptions of Radiation-Induced Pain in Head and Neck Cancer Participants by Visual Analog Scale
time frame: Baseline, 1 week after completing LORETA neurofeedback

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Inclusion: 1. Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements. 2. Patients must not have pain > 2 on a scale of 0 - 10 (self report) in the head and neck before starting radiotherapy. 3. Scheduled to undergo a 6 week course of radiotherapy for head and neck cancer. 4. Patients who are 18 years of age or older. 5. No plans to change the type of pain medication during the course of the study. Exclusion Criteria: 1. Patients who are taking any antipsychotic medications. 2. Patients with active CNS disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy. 3. Patients who have ever been diagnosed with bipolar disorder or schizophrenia. 4. Patients with known, previously diagnosed head or neck pain from other pain syndromes or chronic pain requiring analgesics. 5. Patients with a history of seizure disorders.

Additional Information

Official title Neurofeedback for Acute Radiotherapy-Induced Pain in Head and Neck Cancer Patients
Principal investigator Lorenzo Cohen, PHD
Description Baseline: If participant chooses to take part in this study, before starting radiotherapy the following tests and procedures will be performed: Participant will fill out 4 questionnaires about their pain, how they have been feeling, and their general quality of life. The questionnaires will take about 10 minutes to complete. Participant will have an electroencephalograph (EEG -- a test that measures the electrical activity of the brain) performed. The EEG should take about 1 hour to complete. Neurofeedback Training: If participant develops pain during the first 4 weeks of radiotherapy, they will take part in 3 neurofeedback training sessions each week during either Weeks 4 and 5 or Weeks 5 and 6 of radiotherapy, for a total of 6 training sessions. The neurofeedback training sessions may take place on any day of the week. The session can be at any time, but can be on the same day as a radiation treatment if that is more convenient. Neurofeedback training is a type of therapy that uses EEG and a computer software program to measure brain wave activity. The neurofeedback training will be given in a video-game format and is designed to teach participant ways to slowly re-train their brain wave activity by using "feedback" that they will hear and/or see when their brain waves change in the way the researchers are looking for. With continuing feedback, coaching, and practice, researchers hope participant will be able to learn how to produce the brain wave patterns that may help to reduce the perception of pain and improve their quality of life. For the EEG during each neurofeedback training session, researchers will place a cap containing 19 sensors on participant's scalp, and 1 sensor on each earlobe. The sensors will measure and record participant's brain wave activity, similar to the way a doctor listens to participant's heart beat from the surface of their skin. During each training session, participant will sit quietly and relax while watching a computer screen. A neurotherapist will be present during each neurofeedback session to provide one-on-one assistance and guidance. Each neurofeedback training session will take up 1 hour to complete (about 15 minutes to get set up and about 45 minutes to complete the training session). At each neurofeedback training session: Participant will rate their pain and comfort level on a scale of 0-10 before and after the training session. Participant will rate how much they believe their mouth sores interfere with their quality of life on a scale of 0-10. Participant will be asked about any drugs they may be taking. Follow-Up Visits: Within 1 week of having completed the neurofeedback training sessions, participant will fill out the same 4 questionnaires they completed at baseline and have an EEG performed. Length of Participation: After participant completes the questionnaires at the follow-up visit 1 week after the completion of your LORETA neurofeedback, their participation on this study will be over. This is an investigational study. The equipment used for neurofeedback training is FDA approved and commercially available equipment. Using neurofeedback equipment to teach participants ways to modify their own brain waves to decrease the perception of pain and improve quality of life is investigational. Up to 25 participants will take part in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.