Neurofeedback and Pain

The goal of this study is to learn if using a non-invasive therapy called "neurofeedback training" can help teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life.

Baseline:

On Day 1, the following baseline tests and procedures will be performed:

Participant will fill out 10 questionnaires about their pain, fatigue, how they have been feeling, and their general quality of life. The questionnaire packet may take up to 1 hour 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.

Study Groups:

If participant chooses to take part in this study, after completing the baseline tests and procedures, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.

Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions. The neurofeedback training sessions may take place on any 2 days of the week and may be up to 5 times a week, if participant is interested in training more quickly.

Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits, described below. Group 2 will not take part in the neurofeedback training during Group 1's neurofeedback training period.

Neurofeedback Training (Group 1 only):

Neurofeedback training is a type of therapy that uses an 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 "rewards" 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 quality of life.

For the EEG during each neurofeedback training session, researchers will place 1 or 2 electrodes on participant's scalp and 1 or 2 electrodes on each earlobe. The electrodes 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, the following tests and procedures will be performed:

• Participant will rate their pain on a scale of 0-10.
• Participant will be asked about any drugs they may be taking.

At the 10th training session only, participant will also complete 3 questionnaires about their mood and pain. The questionnaires should take about 10 minutes to complete.

Follow-Up Visits (Both Groups):

If participant is in Group 1:

• After participant has completed neurofeedback training, and again 1 and 4 months later, they will fill out the same 10 questionnaires they completed at baseline.
• An EEG will be performed about 1 week after participant's last neurofeedback training session and again 4 months later.

If participant is in Group 2:

• After Group 1 has completed neurofeedback training, and again 1 and 4 months later, participant will fill out the same 10 questionnaires they completed at baseline.
• An EEG will be performed about 1 week after Group 1 has completed neurofeedback training (up to 10 weeks after baseline) and again 4 months later.

Length of Participation:

If participant is in Group 1, after they complete the questionnaires at the follow-up visit 4 months after their last neurofeedback training session, their active participation on this study will be over.

If participant is in Group 2, they will remain on study for up to 6 ½ months. If participant chooses to take part in the optional procedure, they will remain on study for up to 10 additional weeks to complete neurofeedback training.

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 72 participants will take part in this study. All will be enrolled at M. D. Anderson.

Patients receiving chemotherapy at UT MD Anderson Cancer Center in Houston, Texas

• Pain
• Peripheral Neuropathy

• Behavioral: EEG biofeedback (BF) Group
  Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions.
• Behavioral: Wait-List Control (WLC) Group
  Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits.
• Behavioral: Follow UP Questionnaires
  After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.

• EEG biofeedback (BF) Group
  Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions. After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
  Interventions:

  • Behavioral: EEG biofeedback (BF) Group
  • Behavioral: Follow UP Questionnaires
• Wait-List Control (WLC) Group
  Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits. After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
  Interventions:

  • Behavioral: Wait-List Control (WLC) Group
  • Behavioral: Follow UP Questionnaires

Inclusion Criteria:

1. Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
3. Pain score >/= 4 on a 0-10 numeric pain scale and/or grade 3 neuropathic symptoms according to the National Cancer Institute's 4 point grading scale.
4. Pain must be related to chemotherapy (in the opinion of the treating physician).
5. Patients must have had neuropathic pain for a minimum of 3 months.
6. No plans to change pain medication regimen during the course of the study.
7. Off active chemotherapy treatment for minimum of 3 months.
8. Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.) therapies allowed as long as they will be continued during the course of the study.
9. Willing to come to MD Anderson for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of MDA main campus; or can participate in the therapy sessions from one of MDA's Regional Care Centers.

Exclusion Criteria:

1. Patients who are taking any antipsychotic medications.
2. Patients with active central nervous system (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.