Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT02543320
Brief Summary:
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.
Detailed 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.
Study:
NCT02543320
Study Brief:
Protocol Section:
NCT02543320