Neurofeedback in Decreasing Acute Radiotherapy-Induced Pain in Patients With Head and Neck Cancer

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Head and Neck Carcinoma

Treatments: Other: Questionnaire Administration; Other: LORETA Neurofeedback Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02543320

NCI-2017-00521 (Registry Identifier)

2011-1102 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Determine the effects of an individualized LORETA (low resolution electromagnetic tomography) Z score neurofeedback program on changes in brain function using EEG (electroencephalography), qEEG (quantitative electroencephalography), and LORETA from immediately before to after each session in patients with head and neck cancer undergoing radiotherapy and experiencing pain.

SECONDARY OBJECTIVES:

I. Examine the effects of an individualized LORETA Z score neurofeedback program on perceptions of radiation-induced pain in head and neck cancer patients from immediately before neurofeedback training to immediately after neurofeedback training.

II. Identify brain regions from qEEG and LORETA that are associated with a non-pain state and then an acute pain state.

III. Examine the relationship between the patient and their spouse or primary caregiver.

OUTLINE:

Beginning at weeks 4 and 5 or 5 and 6 of radiotherapy, patients undergo neurofeedback training once per day (QID) three times per week (TIW) for up to 6 treatments. Patients also complete questionnaires over 10 minutes at baseline and after neurofeedback training.

After completion of study, patients are followed up at 1 week.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements
• Patients must not have pain > 2 on a scale of 0 - 10 (self report) in the head and neck before starting radiotherapy
• Scheduled to undergo a 6 week course of radiotherapy for head and neck cancer
• No plans to change the type of pain medication during the course of the study

Exclusion criteria

• Patients who are taking any antipsychotic medications
• Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy
• Patients who have ever been diagnosed with bipolar disorder or schizophrenia
• Patients with known, previously diagnosed head or neck pain from other pain syndromes or chronic pain requiring analgesics
• Patients with a history of seizure disorders

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Supportive care (neurofeedback)

Experimental group

Description:

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.

Treatment:

Other: LORETA Neurofeedback Training

Other: Questionnaire Administration