Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy

NCT02573766 | Active Not Recruiting DMC

• 4 other identifiers: 2015-03995K01AT008485-02NCI-2015-01923CCR-14-800
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effects of Active, Deactivated, and No Neurofeedback (NF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

  Pain Quality Assessment Scale (PQAS) used to evaluate responses in each group.

  4 months

Secondary Outcomes (1)

• Effects of Neurofeedback on the Cortical and Subcortical Regions of the Pain Matrix Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN)

  4 months

Study Arms (3)

Neurofeedback Training

EXPERIMENTAL

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; Procedure: Electroencephalogram; Behavioral: Pain Scale; Behavioral: Questionnaires

Sham Neurofeedback Training

SHAM COMPARATOR

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; Procedure: Electroencephalogram; Behavioral: Pain Scale; Behavioral: Questionnaires

Standard of Care

OTHER

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; Behavioral: Questionnaires

Interventions

Neurofeedback Training PROCEDURE

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.

Neurofeedback Training; Sham Neurofeedback Training

Electroencephalogram PROCEDURE

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.

Also known as: EEG

Neurofeedback Training; Sham Neurofeedback Training; Standard of Care

Pain Scale BEHAVIORAL

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.

Also known as: Questionnaire, Survey

Neurofeedback Training; Sham Neurofeedback Training

Questionnaires BEHAVIORAL

Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.

Also known as: Surveys

Neurofeedback Training; Sham Neurofeedback Training; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• 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.
• Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician).
• Patients must report neuropathic pain for a minimum of 3 months.
• No plans to change pain medication regimen during the course of the study.
• Off active chemotherapy treatment for minimum of 6 months.
• 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.
• Patients who are 18 years of age or above
• Patients who have a diagnosis of breast cancer.

You may not qualify if:

• Patients who are taking any antipsychotic medications.
• Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.
• Patients who have ever been diagnosed with bipolar disorder or schizophrenia.
• Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy.
• Patients who have a history of head injury or who have known seizure activity.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Rising Tide Foundation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sarah Prinsloo

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 12, 2015
• Study Start: October 1, 2015
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)