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

NCT02543320 | Active Not Recruiting

• 2 other identifiers: 2011-1102NCI-2017-00521
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (2)

• EEG

  The qEEG normative database is grouped by age and contains a sufficiently large sample size with means and standard deviations of the EEG time series and/or frequency domain analysis computed for each age group.

  Baseline up to 1 week

• Neurofeeback (LORETA)

  The LORETA software package is used to perform the statistical analyses. The methodology used is non-parametric. It is based on estimating, via randomization, the empirical probability distribution for the max-statistic (e.g. the maximum of a t or an F statistic), under the null hypothesis. This methodology corrects for multiple testing (i.e., for the collection of tests performed for all electrodes and/or voxels, and for all time samples and/or discrete frequencies. Due to the non-parametric nature of the method, its validity need not rely on any assumption of Gaussianity.

  Up to 5 years

Secondary Outcomes (6)

• The Brief Pain Inventory (Short Form)

  Up to 5 years

• The Multidimensional Pain Inventory (MPI)

  Up to 5 years

• The Social Provisions Scale (SPS)

  Up to 5 years

• M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN):

  Up to 5 years

• Visual analog scale to assess pain

  Up to 5 years

Study Arms (1)

Supportive care (neurofeedback)

EXPERIMENTAL

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.

Other: LORETA Neurofeedback Training; Other: Questionnaire Administration

Interventions

LORETA Neurofeedback Training OTHER

Undergo LORETA neurofeedback training

Also known as: LNFB Training, LORETA Neurofeedback, LORETA Z-score Neurofeedback Training, LORETA Z-score NFT, LORETA Z-score Training, LORETA-EEG-NFB, Low Resolution Electromagnetic Tomography Neurofeedback Training, LZNFT

Supportive care (neurofeedback)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (neurofeedback)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

Study Officials

• Sarah Prinsloo

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 7, 2015
• Study Start: August 29, 2012
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)