Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy
NCT02573766 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2025-10-14
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
Interventions
- 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.
- 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.
- BEHAVIORAL
-
Questionnaires
Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.
Sponsors & Collaborators
-
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH -
Rising Tide Foundation
collaborator OTHER -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Sarah Prinsloo · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-01
- Primary Completion
- 2026-10-01
- Completion
- 2026-10-01
Countries
- United States
Study Locations
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