Feasibility of Home-Based Neurofeedback to Treat Chemotherapy-Induced Peripheral Neuropathy
Status: | Not yet recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/11/2019 |
Start Date: | February 2019 |
End Date: | December 2020 |
Contact: | Sarah Prinsloo, PHD |
Email: | sprinsloo@mdanderson.org |
Phone: | 713-563-9627 |
The goal of this clinical research study is to learn if using neurofeedback training can help
teach patients with peripheral neuropathy (nerve damage that affects motor function) how to
change their own brain waves to lower their own perception of symptoms and help improve
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. Neurofeedback training is performed using FDA-approved and
commercially available methods. Using neurofeedback equipment to teach patients ways to
change their own brain waves to lower the perception of symptoms and improve quality of life
is considered investigational.
Up to 20 participants will be enrolled on this study. All will take part at MD Anderson.
teach patients with peripheral neuropathy (nerve damage that affects motor function) how to
change their own brain waves to lower their own perception of symptoms and help improve
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. Neurofeedback training is performed using FDA-approved and
commercially available methods. Using neurofeedback equipment to teach patients ways to
change their own brain waves to lower the perception of symptoms and improve quality of life
is considered investigational.
Up to 20 participants will be enrolled on this study. All will take part at MD Anderson.
Baseline Tests:
If participant agrees to take part in this study, participant will have the following
baseline tests:
- Participant will complete 7 questionnaires about pain, quality of life, symptoms, and
study expectations. It should take about 15 minutes to complete.
- Demographic information about participant (such as participant's age and education
level) will be collected.
- Participant will have an EEG to measure the electrical activity of participant's brain.
During the EEG, researchers will place a cap containing 19 electrodes on participant's
scalp and 1 electrode on each earlobe. The electrodes will measure and record
participant's brain wave activity, similar to the way a doctor listens to participant's
heart beat from the surface of participant's skin. The EEG should take about 45 minutes
to complete.
Study Groups:
After completing the baseline tests, participant will be randomly assigned (as in the flip of
a coin) to 1 of 2 study groups. This is done because no one knows if one study group is
better, the same, or worse than the other group. Participant will have an equal chance
(50/50) of being assigned to either group.
- If participant is assigned to Group 1, participant will receive neurofeedback training.
- If participant is assigned to Group 2, participant will continue to receive standard
care. Participant will not take part in the neurofeedback training.
Participant will be told to which group you have been assigned.
Neurofeedback Training (Group 1 only):
Participant will be given a headset and a laptop computer to take home to complete "training
sessions" which will measure the electrical activity of participant's brain. The study staff
will instruct participant as to how to set up and complete these sessions and will call
participant every day for the first week of training to ensure that the set-up has been done
correctly. This call should last about 5-10 minutes.
Participant will be asked to complete at least 2 training sessions each week for up to 5
weeks (20 training sessions total). Each training session should take about 30 minutes to
complete.
During each session, participant will have the headset on while participant sits quietly,
relaxes, and watches the laptop computer screen. Participant will have a choice of seven
feedback games (for example, a game in which a small character moves around a maze). The
headset will measure and record participant's brain wave activity, like an EEG. The training
session data will be recorded and stored on the laptop's hard drive. The data will be removed
from the laptop before it is given to the next study participant.
At each neurofeedback training session, participant will also rate participant's symptoms on
the computer on a scale of 0-10 before participant begins the neurofeedback training and
again after the session is complete. This should only take a few minutes.
Length of Participation:
Participant's active participation on this study will be over after follow-up (about 5-6
weeks after participant's start date).
Follow-Up (All Participants):
Within 1 week after participant's last neurofeedback training session (if participant was in
Group 1) or about 6 weeks after participant's baseline tests (if participant was in Group 2):
- Participant will fill out the same 7 questionnaires participant completed at baseline.
- Participant will have another EEG.
If participant was in Group 2, participant may be able to begin receiving neurofeedback
training if participant wants to at this point. Participant may talk to the study staff about
this possibility.
If participant agrees to take part in this study, participant will have the following
baseline tests:
- Participant will complete 7 questionnaires about pain, quality of life, symptoms, and
study expectations. It should take about 15 minutes to complete.
- Demographic information about participant (such as participant's age and education
level) will be collected.
- Participant will have an EEG to measure the electrical activity of participant's brain.
During the EEG, researchers will place a cap containing 19 electrodes on participant's
scalp and 1 electrode on each earlobe. The electrodes will measure and record
participant's brain wave activity, similar to the way a doctor listens to participant's
heart beat from the surface of participant's skin. The EEG should take about 45 minutes
to complete.
Study Groups:
After completing the baseline tests, participant will be randomly assigned (as in the flip of
a coin) to 1 of 2 study groups. This is done because no one knows if one study group is
better, the same, or worse than the other group. Participant will have an equal chance
(50/50) of being assigned to either group.
- If participant is assigned to Group 1, participant will receive neurofeedback training.
- If participant is assigned to Group 2, participant will continue to receive standard
care. Participant will not take part in the neurofeedback training.
Participant will be told to which group you have been assigned.
Neurofeedback Training (Group 1 only):
Participant will be given a headset and a laptop computer to take home to complete "training
sessions" which will measure the electrical activity of participant's brain. The study staff
will instruct participant as to how to set up and complete these sessions and will call
participant every day for the first week of training to ensure that the set-up has been done
correctly. This call should last about 5-10 minutes.
Participant will be asked to complete at least 2 training sessions each week for up to 5
weeks (20 training sessions total). Each training session should take about 30 minutes to
complete.
During each session, participant will have the headset on while participant sits quietly,
relaxes, and watches the laptop computer screen. Participant will have a choice of seven
feedback games (for example, a game in which a small character moves around a maze). The
headset will measure and record participant's brain wave activity, like an EEG. The training
session data will be recorded and stored on the laptop's hard drive. The data will be removed
from the laptop before it is given to the next study participant.
At each neurofeedback training session, participant will also rate participant's symptoms on
the computer on a scale of 0-10 before participant begins the neurofeedback training and
again after the session is complete. This should only take a few minutes.
Length of Participation:
Participant's active participation on this study will be over after follow-up (about 5-6
weeks after participant's start date).
Follow-Up (All Participants):
Within 1 week after participant's last neurofeedback training session (if participant was in
Group 1) or about 6 weeks after participant's baseline tests (if participant was in Group 2):
- Participant will fill out the same 7 questionnaires participant completed at baseline.
- Participant will have another EEG.
If participant was in Group 2, participant may be able to begin receiving neurofeedback
training if participant wants to at this point. Participant may talk to the study staff about
this possibility.
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. Neuropathic Pain score >/= 4 on a 0-10 numeric pain scale (Numeric Rating Scale [NRS])
and/or grade 3 or higher neuropathic symptoms according to the National Cancer
Institute's 4 point grading scale
4. Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating
physician)
5. Patients must have had neuropathic symptoms 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 6 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 intake and follow up data acquisition and to
receive their equipment
10. Willing to allow research staff to come to their homes or to return the equipment to
MDA in the case of equipment malfunction
11. Patients who are 18 years of age or above;
12. Have had a diagnosis of cancer treated with chemotherapy
13. Live within a 50 mile radius of MD Anderson's main campus
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
4. Patients with known, previously diagnosed peripheral neuropathy from causes other than
chemotherapy
5. Patients who have a history of head injury or who have known seizure activity.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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