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Effects of Neurofeedback on Neural Function, Neuromodulation, and Chemotherapy-Induced Neuropathic Pain


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Pain, Peripheral Neuropathy

Thank you

Trial Information

Effects of Neurofeedback on Neural Function, Neuromodulation, and Chemotherapy-Induced Neuropathic Pain


Baseline:

On Day 1, the following baseline tests and procedures will be performed:

Participant will fill out 10 questionnaires about their pain, fatigue, how they have been
feeling, and their general quality of life. The questionnaire packet may take up to 1 hour
to complete.

Participant 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 participant chooses to take part in this study, after completing the baseline tests and
procedures, they 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 participant is
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 participant ways to slowly re-train their brain wave
activity by using "rewards" that they will hear and/or see when their brain waves change in
the way the researchers are looking for.

With continuing feedback, coaching, and practice, researchers hope participant 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 participant's scalp and 1 or 2 electrodes 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 their skin.

During each training session, participant 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:

- Participant will rate their pain on a scale of 0-10.

- Participant will be asked about any drugs they may be taking.

At the 10th training session only, participant will also complete 3 questionnaires about
their mood and pain. The questionnaires should take about 10 minutes to complete.

Follow-Up Visits (Both Groups):

If participant is in Group 1:

- After participant has completed neurofeedback training, and again 1 and 4 months later,
they will fill out the same 10 questionnaires they completed at baseline.

- An EEG will be performed about 1 week after participant's last neurofeedback training
session and again 4 months later.

If participant is in Group 2:

- After Group 1 has completed neurofeedback training, and again 1 and 4 months later,
participant will fill out the same 10 questionnaires they 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 participant is in Group 1, after they complete the questionnaires at the follow-up visit
4 months after their last neurofeedback training session, their active participation on this
study will be over.

If participant is in Group 2, they will remain on study for up to 6 ½ months. If
participant chooses to take part in the optional procedure, they 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
participants ways to modify their own brain waves to decrease the perception of pain and
improve quality of life is investigational.

Up to 72 participants will take part in this study. All will be enrolled at M. D. Anderson.


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. 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.

4. Pain must be related to chemotherapy (in the opinion of the treating physician).

5. Patients must have had neuropathic pain 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 3 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 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.

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Effects of Individualized Electroencephalogram (EEG) Biofeedback Treatment Regimen on Perceptions of Chemotherapy-Induced Neuropathic Pain

Outcome Description:

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.

Outcome Time Frame:

10 weeks

Safety Issue:

No

Principal Investigator

Lorenzo Cohen, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0675

NCT ID:

NCT01278225

Start Date:

February 2011

Completion Date:

Related Keywords:

  • Pain
  • Peripheral Neuropathy
  • 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
  • Neuralgia
  • Peripheral Nervous System Diseases

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030