LORETA (Low Resolution Electromagnetic Tomography) Neurofeedback

Baseline:

If you choose to take part in this study, before starting radiotherapy the following tests
and procedures will be performed:

You will fill out 4 questionnaires about your pain, how you have been feeling, and your
general quality of life. The questionnaires will take about 10 minutes to complete.

You 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 you develop pain during the first 4 weeks of radiotherapy, you 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 you ways to slowly re-train your brain wave activity by using
"feedback" that you will hear and/or see when your brain waves change in the way the
researchers are looking for.

With continuing feedback, coaching, and practice, researchers hope you will be able to learn
how to produce the brain wave patterns that may help to reduce the perception of pain and
improve your quality of life.

For the EEG during each neurofeedback training session, researchers will place a cap
containing 19 sensors on your scalp, and 1 sensor on each earlobe. The sensors will measure
and record your brain wave activity, similar to the way a doctor listens to your heart beat
from the surface of your skin.

During each training session, you 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:

You will rate your pain and comfort level on a scale of 0-10 before and after the training
session.

You will rate how much you believe your mouth sores interfere with your quality of life on a
scale of 0-10.

You will be asked about any drugs you may be taking.

Follow-Up Visits:

Within 1 week of having completed the neurofeedback training sessions, you will fill out the
same 4 questionnaires you completed at baseline and have an EEG performed.

Length of Participation:

After you complete the questionnaires at the follow-up visit 1 week after the completion of
your LORETA neurofeedback, your 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
patients ways to modify their own brain waves to decrease the perception of pain and improve
quality of life is investigational.

Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.

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. 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.