PainNCT02573766
Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy
A study testing Neurofeedback Training, Electroencephalogram and Pain Scale in people with Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if using a type of non-invasive therapy called neurofeedback training can help teach patients with peripheral neuropathy how to change their own brain waves to lower their perception of neuropathy and help improve their overall quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Neurofeedback Training, Electroencephalogram and Pain Scale
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 1 Oct 2026
- 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
- Women only
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- 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.
- Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician).
- Patients must report neuropathic pain for a minimum of 3 months.
- No plans to change pain medication regimen during the course of the study.
Show all 10Show fewer
- Off active chemotherapy treatment for minimum of 6 months.
- 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.
- Patients who are 18 years of age or above
- Patients who have a diagnosis of breast cancer.
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 peripheral neuropathy from causes other than chemotherapy.
- Patients who have a history of head injury or who have known seizure activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn if using a type of non-invasive therapy called neurofeedback training can help teach patients with peripheral neuropathy how to change their own brain waves to lower their perception of neuropathy and help improve their overall quality of life.
Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity.
Read more
This is an investigational study. The equipment used for neurofeedback training is FDA approved and commercially available. Using neurofeedback equipment to teach patients ways to modify their own brain waves to lower the perception of symptoms and improve quality of life is considered investigational.
Up to 99 participants over the age of 18 will take part in this study. All will be enrolled at MD Anderson.
Read the detailed description
Baseline Tests:
If you agree to take part in this study, you will have the following baseline tests:
- You will complete 7 questionnaires about your symptoms, how you have been feeling, and your general quality of life. It should take about 20 minutes to complete.
- Basic information about you (such as your age and education level) will also be collected.
- You will have an EEG to measure the electrical activity of your brain. During the EEG, researchers will place a cap containing 19 electrodes on your scalp and 1 electrode 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. The EEG should take about 45 minutes to complete.
Study Groups:
After completing the baseline tests, you will be randomly assigned (as in the roll of a dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If you are assigned to Group 1, you will receive traditional neurofeedback training. Traditional neurofeedback training rewards you based on your own brain's activity.
- If you are assigned to Group 2, you will receive sham neurofeedback training. Sham neurofeedback training does not use your own brainwaves. In sham neurofeedback, you will be training from the brainwaves of another person who does not have neuropathy. Sham neurofeedback is not designed to help train your brainwaves. It is designed to be compared with traditional neurofeedback to learn if traditional neurofeedback has any real effect. If you have any questions about how sham neurofeedback is designed to work, talk with the study doctor or study staff.
- If you are assigned to Group 3, you will continue to receive standard care. You will not take part in the neurofeedback training, but you will take part in the follow-up visits (described below).
If you are assigned to Groups 1 or 2, you will not be told if you are receiving traditional neurofeedback training or sham training.
Neurofeedback Training (Groups 1 and 2):
You will have at least 2 neurofeedback training sessions each week for up to 10 weeks (20 training sessions total). The 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. The study doctor will discuss the option of training faster with you.
Each neurofeedback training session should take about 1 hour to complete.
During each session, you will have an EEG while you sit quietly, relax, and watch a computer screen. The screen will be blank at first and then a series of pictures will appear. The pictures will change as your brainwaves change. You may also be shown pictures of flowers, bridges, mountains, and so on. You may be asked to play small games, for example a Pac-Man type game in which a small character moves around a maze. You will be able to choose to either view pictures or play a game.
When researchers see that your brain waves change in the way they are looking for, you will be "rewarded." When you are rewarded you will see a pretty picture on screen and you will hear a beep.
A neurotherapist will be present during each session to make sure you do not fall asleep and that you are relaxed during the procedure.
At each neurofeedback training session, you will also be asked to rate your neuropathic symptoms on a scale of 0-10 before you begin the neurofeedback training and again after the session is complete. This should only take a few minutes.
Length of Participation:
Your active participation on this study will be over after follow-up. If you are in Groups 2 or 3, you may be able to stay on study for an additional 4 months if you agree to Optional Procedure #1 (described below).
Follow-Up (All groups):
Within 1 week after your last neurofeedback training session and again about 1 month later:
- You will fill out the same 7 questionnaires you completed at baseline.
- You will have an EEG. If you are in Group 3, you will have this EEG about 1 week after Group 1 has completed their neurofeedback training.
- After you have completed the assessment 1 month later, you will be told which group you were in and offered neurofeedback if you were in the sham group.
- Conditions
- Pain
- Being tested
- Neurofeedback Training, Electroencephalogram, Pain Scale, Questionnaires
- Keywords
- Neurofeedback training, EEG, electroencephalograph, Questionnaires, Surveys, Chemotherapy-Induced Peripheral Neuropathy, CIPN
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback TrainingProcedure or surgery
Neurofeedback Group + Sham Neurofeedback Group: Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions.
ElectroencephalogramProcedure or surgery
Also called EEG
Participants undergo an EEG at baseline, during each neurofeedback session, within 7 days of the conclusion of treatment, and again in one month.
Standard of care group receives EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month.
Pain ScaleBehavioural
Also called Questionnaire, Survey
Participants in neurofeedback groups asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback, and again at the conclusion of the session.
QuestionnairesBehavioural
Also called Surveys
Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback Training | Experimental | Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. Participants asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback and again at the conclusion of the session. Participants complete assessments again at the end of treatment and 1 month (+/- 2 weeks) later. Participants undergo an EEG at baseline, during each neurofeedback session, and within 7 days of the conclusion of treatment. Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month. Receives: Procedure: Neurofeedback Training; Procedure: Electroencephalogram; Behavioral: Pain Scale; Behavioral: Questionnaires |
| Sham Neurofeedback Training | Sham comparator | Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. Participants asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback and again at the conclusion of the session. Participants complete assessments again at the end of treatment and 1 month (+/- 2 weeks) later. Participants undergo an EEG at baseline, during each neurofeedback session, and within 7 days of the conclusion of treatment. Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month. Receives: Procedure: Neurofeedback Training; Procedure: Electroencephalogram; Behavioral: Pain Scale; Behavioral: Questionnaires |
| Standard of Care | Other | Seven questionnaires regarding symptoms and quality of life completed at baseline, at follow up, and again in one month. Participants receive EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month. Receives: Procedure: Electroencephalogram; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Active, Deactivated, and No Neurofeedback (NF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Pain Quality Assessment Scale (PQAS) used to evaluate responses in each group.
Measured: 4 months
Secondary outcomes (1)
Effects of Neurofeedback on the Cortical and Subcortical Regions of the Pain Matrix Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Changes in neuromodulation assessed using a quantitative EEG.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Rising Tide Foundation
- Responsible party
- Sponsor
- Investigators
- Sarah Prinsloo, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573766
- Sponsor's protocol ID
- 2015-0399
- Other IDs
- 5K01AT008485-02, NCI-2015-01923, CCR-14-800
- Status last verified
- Oct 2025
- First submitted
- 7 Oct 2015
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT02573766
- Acronym / sponsor ID
- 2015-0399
- Conditions
- Pain
- Keywords
- Neurofeedback training, EEG, electroencephalograph, Questionnaires, Surveys, Chemotherapy-Induced Peripheral Neuropathy, CIPN
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 91 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Rising Tide Foundation
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 12 Oct 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.
The goal of this clinical research study is to learn if using a type of non-invasive therapy called neurofeedback training can help teach patients with peripheral neuropathy how to change their own brain waves to lower their perception of neuropathy and help improve their overall quality of life.
Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity.
This is an investigational study. The equipment used for neurofeedback training is FDA approved and commercially available. Using neurofeedback equipment to teach patients ways to modify their own brain waves to lower the perception of symptoms and improve quality of life is considered investigational.
Up to 99 participants over the age of 18 will take part in this study. All will be enrolled at MD Anderson.
Detailed description
Baseline Tests:
If you agree to take part in this study, you will have the following baseline tests:
- You will complete 7 questionnaires about your symptoms, how you have been feeling, and your general quality of life. It should take about 20 minutes to complete.
- Basic information about you (such as your age and education level) will also be collected.
- You will have an EEG to measure the electrical activity of your brain. During the EEG, researchers will place a cap containing 19 electrodes on your scalp and 1 electrode 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. The EEG should take about 45 minutes to complete.
Study Groups:
After completing the baseline tests, you will be randomly assigned (as in the roll of a dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If you are assigned to Group 1, you will receive traditional neurofeedback training. Traditional neurofeedback training rewards you based on your own brain's activity.
- If you are assigned to Group 2, you will receive sham neurofeedback training. Sham neurofeedback training does not use your own brainwaves. In sham neurofeedback, you will be training from the brainwaves of another person who does not have neuropathy. Sham neurofeedback is not designed to help train your brainwaves. It is designed to be compared with traditional neurofeedback to learn if traditional neurofeedback has any real effect. If you have any questions about how sham neurofeedback is designed to work, talk with the study doctor or study staff.
- If you are assigned to Group 3, you will continue to receive standard care. You will not take part in the neurofeedback training, but you will take part in the follow-up visits (described below).
If you are assigned to Groups 1 or 2, you will not be told if you are receiving traditional neurofeedback training or sham training.
Neurofeedback Training (Groups 1 and 2):
You will have at least 2 neurofeedback training sessions each week for up to 10 weeks (20 training sessions total). The 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. The study doctor will discuss the option of training faster with you.
Each neurofeedback training session should take about 1 hour to complete.
During each session, you will have an EEG while you sit quietly, relax, and watch a computer screen. The screen will be blank at first and then a series of pictures will appear. The pictures will change as your brainwaves change. You may also be shown pictures of flowers, bridges, mountains, and so on. You may be asked to play small games, for example a Pac-Man type game in which a small character moves around a maze. You will be able to choose to either view pictures or play a game.
When researchers see that your brain waves change in the way they are looking for, you will be "rewarded." When you are rewarded you will see a pretty picture on screen and you will hear a beep.
A neurotherapist will be present during each session to make sure you do not fall asleep and that you are relaxed during the procedure.
At each neurofeedback training session, you will also be asked to rate your neuropathic symptoms on a scale of 0-10 before you begin the neurofeedback training and again after the session is complete. This should only take a few minutes.
Length of Participation:
Your active participation on this study will be over after follow-up. If you are in Groups 2 or 3, you may be able to stay on study for an additional 4 months if you agree to Optional Procedure #1 (described below).
Follow-Up (All groups):
Within 1 week after your last neurofeedback training session and again about 1 month later:
- You will fill out the same 7 questionnaires you completed at baseline.
- You will have an EEG. If you are in Group 3, you will have this EEG about 1 week after Group 1 has completed their neurofeedback training.
- After you have completed the assessment 1 month later, you will be told which group you were in and offered neurofeedback if you were in the sham group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback Training | Experimental | Procedure: Neurofeedback Training, Procedure: Electroencephalogram, Behavioral: Pain Scale, Behavioral: QuestionnairesParticipants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. Participants asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback and again at the conclusion of the session. Participants complete assessments again at the end of treatment and 1 month (+/- 2 weeks) later. Participants undergo an EEG at baseline, during each neurofeedback session, and within 7 days of the conclusion of treatment. Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month. |
| Sham Neurofeedback Training | Sham comparator | Procedure: Neurofeedback Training, Procedure: Electroencephalogram, Behavioral: Pain Scale, Behavioral: QuestionnairesParticipants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. Participants asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback and again at the conclusion of the session. Participants complete assessments again at the end of treatment and 1 month (+/- 2 weeks) later. Participants undergo an EEG at baseline, during each neurofeedback session, and within 7 days of the conclusion of treatment. Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month. |
| Standard of Care | Other | Procedure: Electroencephalogram, Behavioral: QuestionnairesSeven questionnaires regarding symptoms and quality of life completed at baseline, at follow up, and again in one month. Participants receive EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- 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.
- Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician).
- Patients must report neuropathic pain for a minimum of 3 months.
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 peripheral neuropathy from causes other than chemotherapy.
- Patients who have a history of head injury or who have known seizure activity.
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 |
|---|---|---|
| Neurofeedback TrainingNeurofeedback Group + Sham Neurofeedback Group: Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. | Procedure or surgery | Neurofeedback Training, Sham Neurofeedback Training |
| ElectroencephalogramAlso: EEGParticipants undergo an EEG at baseline, during each neurofeedback session, within 7 days of the conclusion of treatment, and again in one month. Standard of care group receives EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month. | Procedure or surgery | Neurofeedback Training, Sham Neurofeedback Training, Standard of Care |
| Pain ScaleAlso: Questionnaire, SurveyParticipants in neurofeedback groups asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback, and again at the conclusion of the session. | Behavioural | Neurofeedback Training, Sham Neurofeedback Training |
| QuestionnairesAlso: SurveysSeven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month. | Behavioural | Neurofeedback Training, Sham Neurofeedback Training, Standard of Care |
Primary outcome
Effects of Active, Deactivated, and No Neurofeedback (NF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Time frame: 4 months
Pain Quality Assessment Scale (PQAS) used to evaluate responses in each group.
1 secondary outcome
Effects of Neurofeedback on the Cortical and Subcortical Regions of the Pain Matrix Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Time frame: 4 months
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 14 Oct 2025.
- University of Texas MD Anderson Cancer Center WebsiteLink 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 Neurofeedback Training, Electroencephalogram and Pain Scale in people with Pain, 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 10 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 14 Oct 2025. 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. Some participants in this study may receive a placebo. 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?
Effects of Active, Deactivated, and No Neurofeedback (NF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) (time frame: 4 months). 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 14 Oct 2025.