Head and Neck CarcinomaNCT02543320
Neurofeedback in Decreasing Acute Radiotherapy-Induced Pain in Patients With Head and Neck Cancer
A study testing LORETA Neurofeedback Training and Questionnaire Administration in people with Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- LORETA Neurofeedback Training and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2012to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Neurofeedback for Acute Radiotherapy-Induced Pain in Head and Neck Cancer Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Head and Neck Carcinoma
- Being tested
- LORETA Neurofeedback Training, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LORETA Neurofeedback TrainingOther
Also called LNFB Training, LORETA Neurofeedback, LORETA Z-score Neurofeedback Training, LORETA Z-score NFT
Undergo LORETA neurofeedback training
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: LORETA Neurofeedback Training; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years
Secondary outcomes (6)
The Brief Pain Inventory (Short Form)
is a validated, widely used, self-administered questionnaire to assess severity of pain and impact of pain on daily functioning among patients (Cleeland, 2006; Cleeland, 1991; Tan, 2004). The Brief Pain Inventory (Short form) Scale 0-10 (No Pain 0-10 As Bad as you can imagine ).
Measured: Up to 5 years
The Multidimensional Pain Inventory (MPI)
is a measure generally used in chronic pain conditions used to measure the patient perception of their pain experience. The MPI has 4 subscales that assess pain intensity, emotional distress, cognitive and functional adaptation, and social support. It is used to assess overall adjustment of pain and outcomes of treatment interventions. Although it is generally used for chronic pain patients, the MPI has also been used in studies with patients who have acute pain (Edwards, Et al., 2006; Montes Doncel, et al., 2001).
Measured: Up to 5 years
The Social Provisions Scale (SPS)
will also be administered with the MPI as a measure of validity. The inclusion of these measures allows us to assess perceived relational support in general (SPS) and in specific relation to their pain (MPI). For the patients who consent to their spouses/caregivers participating in the optional survey, the spouses/caregivers will be given the SPS at the same timepoints as the patient.
Measured: Up to 5 years
M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN):
Cancer-related symptoms will be assessed using the validated MDASI-HN. The MDASI measures, on a numeric rating scale of 0-10, both the severity of symptoms and the interference symptoms cause in patients" daily activities. The 13 core MDASI symptom items are based on extensive evaluation of symptoms common to cancer and cancer treatment. The MDASI-HN includes 9 head and neck-specific items. The instrument was validated in a cohort of more than 200 patients and found to be highly reliable (Rosenthal, Mendoza, \& Chambers, 2007).
Measured: Up to 5 years
Visual analog scale to assess pain
A visual analog scale to assess pain (0-10 scale) will be used before and after each training session to determine if change in brain function is meaningful clinically.
A visual analog scale to assess mouth sores (0-10 scale) will be used before each training session to determine patient perception of interference with quality of life due to mucositis. A visual analog scale to assess patient comfort (0-10 scale) will be used before and after each training session to determine patient perception of overall comfort.
Measured: Up to 5 years
Pain medication use
All medications prescribed and used by the patients for pain or other medical conditions will be collected during the time they are participating in the study. We will use descriptive statistics to summarize pain medication use over the course of the study and radiation dose. We will tabulate adverse events by grade and relationship to therapy.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start29 Aug 2012
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sarah Prinsloo, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543320
- Sponsor's protocol ID
- 2011-1102
- Other IDs
- NCI-2017-00521, 2011-1102
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2015
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback for Acute Radiotherapy-Induced Pain in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT02543320
- Acronym / sponsor ID
- 2011-1102
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Aug 2012 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (neurofeedback) | Experimental | Other: LORETA Neurofeedback Training, Other: Questionnaire AdministrationBeginning 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LORETA Neurofeedback TrainingAlso: LNFB Training, LORETA Neurofeedback, LORETA Z-score Neurofeedback Training, LORETA Z-score NFTUndergo LORETA neurofeedback training | Other | Supportive care (neurofeedback) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (neurofeedback) |
Primary outcome
EEG
Time frame: Baseline up to 1 week
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.
Neurofeeback (LORETA)
Time frame: Up to 5 years
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.
6 secondary outcomes
The Brief Pain Inventory (Short Form)
Time frame: Up to 5 years
The Multidimensional Pain Inventory (MPI)
Time frame: Up to 5 years
The Social Provisions Scale (SPS)
Time frame: Up to 5 years
M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN):
Time frame: Up to 5 years
Visual analog scale to assess pain
Time frame: Up to 5 years
Pain medication use
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Prinsloo principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LORETA Neurofeedback Training and Questionnaire Administration in people with Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: Baseline up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.