Neurofeedback in Decreasing Acute Radiotherapy-Induced Pain in Patients With Head and Neck Cancer
NCT ID: NCT02543320
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
17 participants
INTERVENTIONAL
2012-08-29
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (neurofeedback)
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.
LORETA Neurofeedback Training
Undergo LORETA neurofeedback training
Questionnaire Administration
Ancillary studies
Interventions
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LORETA Neurofeedback Training
Undergo LORETA neurofeedback training
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sarah Prinsloo
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2017-00521
Identifier Type: REGISTRY
Identifier Source: secondary_id
2011-1102
Identifier Type: OTHER
Identifier Source: secondary_id
2011-1102
Identifier Type: -
Identifier Source: org_study_id
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