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LORETA (Low Resolution Electromagnetic Tomography) Neurofeedback

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ClinicalTrials.gov Identifier: NCT02543320
Recruitment Status : Active, not recruiting
First Posted : September 7, 2015
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this study is to learn how the brain processes pain and if using 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 or disease Intervention/treatment Phase
Head and Neck Cancer Device: Electroencephalography (EEG) Behavioral: Questionnaires Procedure: Neurotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurofeedback for Acute Radiotherapy-Induced Pain in Head and Neck Cancer Patients
Actual Study Start Date : August 29, 2012
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LORETA Neurofeedback
Participants undergo a baseline EEG prior to starting radiotherapy and during each neurotherapy session as required by LORETA. Participants undergo neurotherapy once a day, three days a week, for a total of 6 treatments. Pain and symptom questionnaires completed at baseline, before each LORETA neurofeedback session, 1 week after completion of neurofeedback sessions, and at the end of radiotherapy.
Device: Electroencephalography (EEG)
Participants undergo a baseline EEG prior to starting radiotherapy, and during each neurotherapy session.
Other Name: EEG

Behavioral: Questionnaires
Pain and symptom questionnaires completed at baseline, before each LORETA neurofeedback session, 1 week after completion of neurofeedback sessions, and at the end of radiotherapy.
Other Name: Surveys

Procedure: Neurotherapy
Participants undergo neurotherapy once a day, three days a week, for a total of 6 treatments over a two week time period, and during weeks 4 and 5 or 5 and 6 of radiotherapy, depending on when they start to experience pain of at least a 4 on a pain scale of 0-10 for three consecutive days. Neurofeedback training given in a video-game format.




Primary Outcome Measures :
  1. Changes in Brain Function Using EEG (Electroencephalography) and LORETA in Perceptions of Radiation-Induced Pain in Head and Neck Cancer Participants [ Time Frame: Baseline, 1 week after completing LORETA neurofeedback ]
    Changes in neuromodulation assessed using EEG and LORETA. LORETA software package used to perform statistical analyses.


Secondary Outcome Measures :
  1. Effects of Individualized LORETA Z Score Neurofeedback Program on Perceptions of Radiation-Induced Pain in Head and Neck Cancer Participants by Brief Pain Inventory (BPI) [ Time Frame: Baseline, 1 week after completing LORETA neurofeedback ]
    Effects determined by Brief Pain Inventory (BPI).

  2. Effects of Individualized LORETA Z Score Neurofeedback Program on Perceptions of Radiation-Induced Pain in Head and Neck Cancer Participants by the M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) [ Time Frame: Baseline, 1 week after completing LORETA neurofeedback ]
    Effects determined by the M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN).

  3. Effects of Individualized LORETA Z Score Neurofeedback Program on Perceptions of Radiation-Induced Pain in Head and Neck Cancer Participants by Visual Analog Scale [ Time Frame: Baseline, 1 week after completing LORETA neurofeedback ]
    Effects determined by visual analog scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Patients must not have pain > 2 on a scale of 0 - 10 (self report) in the head and neck before starting radiotherapy.
  3. Scheduled to undergo a 6 week course of radiotherapy for head and neck cancer.
  4. Patients who are 18 years of age or older.
  5. No plans to change the type of pain medication during the course of the study.

Exclusion Criteria:

  1. Patients who are taking any antipsychotic medications.
  2. Patients with active 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 head or neck pain from other pain syndromes or chronic pain requiring analgesics.
  5. Patients with a history of seizure disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543320


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

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02543320     History of Changes
Other Study ID Numbers: 2011-1102
NCI-2017-00521 ( Registry Identifier: NCI CTRP )
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
LORETA
Low Resolution Electromagnetic Tomography
Pain
Radiotherapy
Electroencephalograph
EEG
Questionnaires
Surveys
Neurofeedback training

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms