Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy
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.
Disease Group: Pain
Treatment Agent: Behavioral intervention
Treatment Location: Only at MDACC
Sponsor: National Center for Complementary and Integrative Health (NCCIH),Rising Tide Foundation
Primary Objective 1. Examine the effects of neurofeedback (NF) on symptoms of chemotherapy-induced peripheral neuropathy (CIPN) versus deactivated neurofeedback (DN) and waitlist (WL) control groups in breast cancer patients. Secondary Objectives 1. Examine the effects of neurofeedback on the cortical and subcortical regions of the pain matrix associated with CIPN and NF versus DN and WL, including connectivity analysis. 2. Examine the effects of NF on other aspects of pain, cancer-related symptoms, quality of life (QOL), mental health, and objective functional measures. 3. Examine the effects of moderators/mediators of the intervention by examining the extent to which changes in electroencephalogram (EEG) patterns mediate the effects of the intervention, the extent to which placebo and placebo brain regions mediate the effects of the intervention, and whether the therapeutic relationship and expectations moderate the effect of neurofeedback on outcomes.
IRB Review and Approval Date: 10/01/2015
Recruitment Status: Open
Projected Accrual: N/A
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.
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 and next steps
Palliative Care and Rehabilitation Medicine
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