Effects of Neurofeedback on Neural Function, Neuromodulation, and Chemotherapy-Induced Neuropathic Pain

February 18, 2026 updated by: M.D. Anderson Cancer Center
The goal of this study is to learn if using a non-invasive therapy called "neurofeedback training" can help teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Baseline:

On Day 1, the following baseline tests and procedures will be performed:

  • You will fill out 10 questionnaires about your pain, fatigue, how you have been feeling, and your general quality of life. The questionnaire packet may take up to 1 hour to complete.
  • You will have an electroencephalograph (EEG -- a test that measures the electrical activity of the brain) performed. The EEG should take about 1 hour to complete.

Study Groups:

If you choose to take part in this study, after completing the baseline tests and procedures, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.

Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions. The neurofeedback training sessions may take place on any 2 days of the week and may be up to 5 times a week, if you are interested in training more quickly.

Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits, described below. Group 2 will not take part in the neurofeedback training during Group 1's neurofeedback training period.

Neurofeedback Training (Group 1 only):

Neurofeedback training is a type of therapy that uses an EEG and a computer software program to measure brain wave activity. The neurofeedback training will be given in a video-game format and is designed to teach you ways to slowly re-train your brain wave activity by using "rewards" that you will hear and/or see when your brain waves change in the way the researchers are looking for.

With continuing feedback, coaching, and practice, researchers hope you will be able to learn how to produce the brain wave patterns that may help to reduce the perception of pain and improve quality of life.

For the EEG during each neurofeedback training session, researchers will place 1 or 2 electrodes on your scalp and 1 or 2 electrodes on each earlobe. The electrodes will measure and record your brain wave activity, similar to the way a doctor listens to your heart beat from the surface of your skin.

During each training session, you will sit quietly and relax while watching a computer screen. A neurotherapist will be present during each neurofeedback session to provide one-on-one assistance and guidance. Each neurofeedback training session will take up 1 hour to complete (about 15 minutes to get set up and about 45 minutes to complete the training session).

At each neurofeedback training session, the following tests and procedures will be performed:

  • You will rate your pain on a scale of 0-10.
  • You will be asked about any drugs you may be taking.

At the 10th training session only, you will also complete 3 questionnaires about your mood and pain. The questionnaires should take about 10 minutes to complete.

Follow-Up Visits (Both Groups):

If you are in Group 1:

  • After you have completed neurofeedback training, and again 1 and 4 months later, you will fill out the same 10 questionnaires you completed at baseline.
  • An EEG will be performed about 1 week after your last neurofeedback training session and again 4 months later.

If you are in Group 2:

  • After Group 1 has completed neurofeedback training, and again 1 and 4 months later, you will fill out the same 10 questionnaires you completed at baseline.
  • An EEG will be performed about 1 week after Group 1 has completed neurofeedback training (up to 10 weeks after baseline) and again 4 months later.

Length of Participation:

If you are in Group 1, after you complete the questionnaires at the follow-up visit 4 months after your last neurofeedback training session, your active participation on this study will be over.

If you are in Group 2, you will remain on study for up to 6 ½ months. If you choose to take part in the optional procedure, you will remain on study for up to 10 additional weeks to complete neurofeedback training.

This is an investigational study. The equipment used for neurofeedback training is FDA approved and commercially available equipment. Using neurofeedback equipment to teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life is investigational.

Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients receiving chemotherapy at UT MD Anderson Cancer Center in Houston, Texas

Description

Inclusion Criteria:

  1. Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  3. Pain score >/= 4 on a 0-10 numeric pain scale and/or grade 3 neuropathic symptoms according to the National Cancer Institute's 4 point grading scale.
  4. Pain must be related to chemotherapy (in the opinion of the treating physician).
  5. Patients must have had neuropathic pain for a minimum of 3 months.
  6. No plans to change pain medication regimen during the course of the study.
  7. Off active chemotherapy treatment for minimum of 3 months.
  8. Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.) therapies allowed as long as they will be continued during the course of the study.
  9. Willing to come to MD Anderson for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of MDA main campus; or can participate in the therapy sessions from one of MDA's Regional Care Centers.

Exclusion Criteria:

  1. Patients who are taking any antipsychotic medications.
  2. Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.
  3. Patients who have ever been diagnosed with bipolar disorder or schizophrenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EEG biofeedback (BF) Group
Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions. After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
Behavioral: EEG biofeedback (BF) Group
Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions.
Behavioral: Follow UP Questionnaires
After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
Wait-List Control (WLC) Group
Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits. After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
Behavioral: Follow UP Questionnaires
After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
Behavioral: Wait-List Control (WLC) Group
Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Individualized Electroencephalogram (EEG) Biofeedback Treatment Regimen on Perceptions of Chemotherapy-Induced Neuropathic Pain
Time Frame: 10 weeks
After Group 1 has completed neurofeedback training, both Groups will fill out the same 10 questionnaires that were completed at baseline. An EEG will be performed on both Groups about 1 week after Group 1 completes last neurofeedback training, and again 4 months later.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Sarah Prinsloo, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimated)

January 17, 2011

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0675
  • NCI-2014-02452 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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