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Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT02573766
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Rising Tide Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if using a type of non-invasive therapy called neurofeedback training can help teach patients with peripheral neuropathy how to change their own brain waves to lower their perception of neuropathy and help improve their 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. The equipment used for neurofeedback training is FDA approved and commercially available. Using neurofeedback equipment to teach patients ways to modify their own brain waves to lower the perception of symptoms and improve quality of life is considered investigational.

Up to 99 participants over the age of 18 will take part in this study. All will be enrolled at MD Anderson.


Condition or disease Intervention/treatment Phase
Pain Procedure: Neurofeedback Training Procedure: Electroencephalogram Behavioral: Pain Scale Behavioral: Questionnaires Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neurofeedback Training
Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. Participants asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback and again at the conclusion of the session. Participants complete assessments again at the end of treatment and 1 month (+/- 2 weeks) later. Participants undergo an EEG at baseline, during each neurofeedback session, and within 7 days of the conclusion of treatment. Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.
Procedure: Neurofeedback Training
Neurofeedback Group + Sham Neurofeedback Group: Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions.

Procedure: Electroencephalogram

Participants undergo an EEG at baseline, during each neurofeedback session, within 7 days of the conclusion of treatment, and again in one month.

Standard of care group receives EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month.

Other Name: EEG

Behavioral: Pain Scale
Participants in neurofeedback groups asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback, and again at the conclusion of the session.
Other Names:
  • Questionnaire
  • Survey

Behavioral: Questionnaires
Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.
Other Name: Surveys

Sham Comparator: Sham Neurofeedback Training
Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions. Participants asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback and again at the conclusion of the session. Participants complete assessments again at the end of treatment and 1 month (+/- 2 weeks) later. Participants undergo an EEG at baseline, during each neurofeedback session, and within 7 days of the conclusion of treatment. Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.
Procedure: Neurofeedback Training
Neurofeedback Group + Sham Neurofeedback Group: Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions.

Procedure: Electroencephalogram

Participants undergo an EEG at baseline, during each neurofeedback session, within 7 days of the conclusion of treatment, and again in one month.

Standard of care group receives EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month.

Other Name: EEG

Behavioral: Pain Scale
Participants in neurofeedback groups asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback, and again at the conclusion of the session.
Other Names:
  • Questionnaire
  • Survey

Behavioral: Questionnaires
Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.
Other Name: Surveys

Standard of Care
Seven questionnaires regarding symptoms and quality of life completed at baseline, at follow up, and again in one month. Participants receive EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month.
Procedure: Electroencephalogram

Participants undergo an EEG at baseline, during each neurofeedback session, within 7 days of the conclusion of treatment, and again in one month.

Standard of care group receives EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month.

Other Name: EEG

Behavioral: Questionnaires
Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.
Other Name: Surveys




Primary Outcome Measures :
  1. Effects of Active, Deactivated, and No Neurofeedback (NF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) [ Time Frame: 4 months ]
    Pain Quality Assessment Scale (PQAS) used to evaluate responses in each group.


Secondary Outcome Measures :
  1. Effects of Neurofeedback on the Cortical and Subcortical Regions of the Pain Matrix Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN) [ Time Frame: 4 months ]
    Changes in neuromodulation assessed using a quantitative EEG.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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. 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. Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician).
  5. Patients must report 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 6 months.
  8. 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.
  9. Patients who are 18 years of age or above
  10. Patients who have a diagnosis of breast cancer.

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.

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): NCT02573766


Contacts
Contact: Sarah Prinsloo, PHD 713-563-9627

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Center for Complementary and Integrative Health (NCCIH)
Rising Tide Foundation
Investigators
Principal Investigator: Sarah Prinsloo M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02573766     History of Changes
Other Study ID Numbers: 2015-0399
5K01AT008485-02 ( U.S. NIH Grant/Contract )
NCI-2015-01923 ( Registry Identifier: NCI CTRP )
CCR-14-800 ( Other Grant/Funding Number: Rising Tide Foundation )
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

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:
Neurofeedback training
EEG
electroencephalograph
Questionnaires
Surveys
Chemotherapy-Induced Peripheral Neuropathy
CIPN

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