Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5K01AT008485-02 | U.S. NIH Grant/Contract | View source | |
| NCI-2015-01923 | Registry Identifier | NCI CTRP | |
| CCR-14-800 | Other Grant/Funding Number | Rising Tide Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Rising Tide Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Baseline Tests:
If you agree to take part in this study, you will have the following baseline tests:
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 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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback Training | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah Prinsloo | 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 |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Electroencephalogram | Procedure | 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 Scale | Behavioral | 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. |
|
|
| Questionnaires | Behavioral | Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month. |
|
|
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |