PainNCT01278225
Effects of Neurofeedback on Neural Function, Neuromodulation, and Chemotherapy-Induced Neuropathic Pain
An observational study of Pain and Peripheral Neuropathy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Peripheral Neuropathy
- What is being tested?
- EEG biofeedback (BF) Group and Follow UP Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to 1 Apr 2027
- Phase
- Observational
- 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
Study population: Patients receiving chemotherapy at UT MD Anderson Cancer Center in Houston, Texas
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.
- Pain must be related to chemotherapy (in the opinion of the treating physician).
- Patients must have had neuropathic pain for a minimum of 3 months.
- No plans to change pain medication regimen during the course of the study.
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- Off active chemotherapy treatment for minimum of 3 months.
- 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.
- 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.
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.
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 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.
Read the 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.
- Conditions
- Pain, Peripheral Neuropathy
- Being tested
- EEG biofeedback (BF) Group, Wait-List Control (WLC) Group, Follow UP Questionnaires
- Keywords
- Neurofeedback, Neural Function, Neuromodulation, Chemotherapy-Induced Neuropathic Pain, Electroencephalogram, EEG, Biofeedback, BF, Quality of Life, QOL, Pain Quality Assessment Scale, PQAS, Brief Symptom Inventory, BSI, Sleep Disturbances, Fatigue, Questionnaires
- Medical subject headings
- Pain, Peripheral Nervous System Diseases, Parasomnias, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG biofeedback (BF) GroupBehavioural
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.
Wait-List Control (WLC) GroupBehavioural
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.
Follow UP QuestionnairesBehavioural
After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: EEG biofeedback (BF) Group; Behavioral: Follow UP Questionnaires | |
| 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. Receives: Behavioral: Wait-List Control (WLC) Group; Behavioral: Follow UP Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Individualized Electroencephalogram (EEG) Biofeedback Treatment Regimen on Perceptions of Chemotherapy-Induced Neuropathic Pain
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Prinsloo, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278225
- Sponsor's protocol ID
- 2010-0675
- Other IDs
- NCI-2014-02452
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2011
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prinsloo S, Novy D, Driver L, Lyle R, Ramondetta L, Eng C, Lopez G, Li Y, Cohen L. The Long-Term Impact of Neurofeedback on Symptom Burden and Interference in Patients With Chronic Chemotherapy-Induced Neuropathy: Analysis of a Randomized Controlled Trial. J Pain Symptom Manage. 2018 May;55(5):1276-1285. doi: 10.1016/j.jpainsymman.2018.01.010. Epub 2018 Feb 5.
PubMed 29421164
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurofeedback on Neural Function, Neuromodulation, and Chemotherapy-Induced Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01278225
- Acronym / sponsor ID
- 2010-0675
- Conditions
- Pain, Peripheral Neuropathy
- Keywords
- Neurofeedback, Neural Function, Neuromodulation, Chemotherapy-Induced Neuropathic Pain, Electroencephalogram, EEG, Biofeedback, BF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Jan 2011 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG biofeedback (BF) Group | – | Behavioral: EEG biofeedback (BF) Group, Behavioral: Follow UP QuestionnairesGroup 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. |
| Wait-List Control (WLC) Group | – | Behavioral: Wait-List Control (WLC) Group, Behavioral: Follow UP QuestionnairesGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving chemotherapy at UT MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (9 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.
- Pain must be related to chemotherapy (in the opinion of the treating physician).
- Patients must have had neuropathic pain for a minimum of 3 months.
Key exclusion criteria (3 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.
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 |
|---|---|---|
| EEG biofeedback (BF) GroupGroup 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. | Behavioural | EEG biofeedback (BF) Group |
| Wait-List Control (WLC) GroupGroup 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. | Behavioural | Wait-List Control (WLC) Group |
| Follow UP QuestionnairesAfter Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline. | Behavioural | EEG biofeedback (BF) Group, Wait-List Control (WLC) Group |
Primary outcome
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.
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 11 Aug 2026.
- Derived from this study: PubMed 29421164Prinsloo S, Novy D, Driver L, Lyle R, Ramondetta L, Eng C, Lopez G, Li Y, Cohen L. The Long-Term Impact of Neurofeedback on Symptom Burden and Interference in Patients With Chronic Chemotherapy-Induced Neuropathy: Analysis of a Randomized Controlled Trial. J Pain Symptom Manage. 2018 May;55(5):1276-1285. doi: 10.1016/j.jpainsymman.2018.01.010. Epub 2018 Feb 5.
- 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, PHD 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?
An observational study of Pain and Peripheral Neuropathy, 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 9 inclusion and 3 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 11 Aug 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?
Effects of Individualized Electroencephalogram (EEG) Biofeedback Treatment Regimen on Perceptions of Chemotherapy-Induced Neuropathic Pain (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278225, which also lists 1 linked publication.
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 11 Aug 2026.