Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Neurofeedback and Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01278225
First received: January 14, 2011
Last updated: February 6, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Pain
Peripheral Neuropathy
Behavioral: EEG biofeedback (BF) Group
Behavioral: Wait-List Control (WLC) Group
Behavioral: Follow UP Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Neurofeedback on Neural Function, Neuromodulation, and Chemotherapy-Induced Neuropathic Pain

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Actual Study Start Date: February 2011
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: 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.
Behavioral: Follow UP Questionnaires
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.
Behavioral: 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.
Behavioral: Follow UP Questionnaires
After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving chemotherapy at UT MD Anderson Cancer Center in Houston, Texas
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278225

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lorenzo Cohen, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01278225     History of Changes
Other Study ID Numbers: 2010-0675
NCI-2014-02452 ( Registry Identifier: NCI CTRP )
Study First Received: January 14, 2011
Last Updated: February 6, 2017

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 28, 2017