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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02452 | Registry Identifier | NCI CTRP |
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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.
Baseline:
On Day 1, the following baseline tests and procedures will be performed:
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:
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:
If you are in Group 2:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG biofeedback (BF) Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving chemotherapy at UT MD Anderson Cancer Center in Houston, Texas
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Prinsloo, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29421164 | Derived | 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. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Wait-List Control (WLC) Group | Behavioral | 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 Questionnaires | Behavioral | After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline. |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| D010523 | Peripheral Nervous System Diseases |
| D020447 | Parasomnias |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| D003710 | Demography |
| D011154 | Population Characteristics |
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