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Neurofeedback and Pain

This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01278225
First received: January 14, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  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 Phase
Pain
Peripheral Neuropathy
 Behavioral: EEG biofeedback (BF) Group
Behavioral: Wait-List Control (WLC) Group
Behavioral: Follow UP Questionnaires
 Phase 0

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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: 72
Study Start Date: February 2011
Estimated Primary Completion Date: March 2015 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278225

Contacts
Contact: Donna S. Capps, MA 713-792-1854 dscapps@mdanderson.org

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

Additional Information:
UT MD Anderson Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01278225     History of Changes
Other Study ID Numbers: 2010-0675
Study First Received: January 14, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

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:
Neuralgia
Peripheral Nervous System Diseases
Pain
Neurologic Manifestations
 Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013