Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-28 @ 6:38 PM
Study NCT ID:
NCT02543320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2015-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurofeedback in Decreasing Acute Radiotherapy-Induced Pain in Patients With Head and Neck Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Neurofeedback for Acute Radiotherapy-Induced Pain in Head and Neck Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: