← Back to Search

Behavioral Intervention

Neuromodulation for Peripheral Neuropathy

N/A
Waitlist Available
Led By Sarah Prinsloo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are 18 years of age or above
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

This trial is assessing whether neurofeedback training can help patients with peripheral neuropathy lower their perception of symptoms and improve quality of life.

Who is the study for?
This trial is for adults over 18 with pain from chemotherapy-induced peripheral neuropathy, who've had this pain for at least 3 months and rate it at least a 4 on a scale of 0-10. They must be off chemo for six months, not planning to change their pain meds during the study, able to understand English, sign consent, and follow the protocol. They can't join if they have certain mental health conditions, other causes of neuropathy, CNS disease or seizures.Check my eligibility
What is being tested?
The study tests neurofeedback training—a non-invasive therapy using EEG to measure brain waves—to see if patients can learn to alter their brain activity to reduce neuropathy perception and improve life quality. All participants will receive this investigational use of FDA-approved equipment either at MD Anderson or within a specific distance from it.See study design
What are the potential side effects?
Since neurofeedback training is non-invasive and uses existing FDA-approved equipment in an investigational manner, significant side effects are not anticipated. However, discomfort related to wearing EEG equipment may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am able to care for myself and perform daily activities.
Select...
My pain level is 4 or higher, or I have severe nerve pain.
Select...
I have been experiencing nerve pain for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effects of Active, Deactivated, and No Neurofeedback (NF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Secondary outcome measures
Effects of Neurofeedback on the Cortical and Subcortical Regions of the Pain Matrix Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard of CareExperimental Treatment2 Interventions
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.
Group II: Neurofeedback TrainingExperimental Treatment4 Interventions
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.
Group III: Sham Neurofeedback TrainingPlacebo Group4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pain Scale
2017
Completed Phase 4
~80
Electroencephalogram
2012
N/A
~90
Questionnaires
2013
Completed Phase 2
~3330

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,711 Total Patients Enrolled
15 Trials studying Pain
1,330 Patients Enrolled for Pain
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,842 Total Patients Enrolled
33 Trials studying Pain
19,689 Patients Enrolled for Pain
Rising Tide FoundationOTHER
13 Previous Clinical Trials
4,136 Total Patients Enrolled

Media Library

Neurofeedback Training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02573766 — N/A
Pain Research Study Groups: Standard of Care, Neurofeedback Training, Sham Neurofeedback Training
Pain Clinical Trial 2023: Neurofeedback Training Highlights & Side Effects. Trial Name: NCT02573766 — N/A
Neurofeedback Training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02573766 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still looking for participants?

"According to the latest information on clinicaltrials.gov, this study is not looking for new participants at this time. The original posting date was October 1st, 2015 and there have been no edits since February 23rd, 2022. There are 525 other trials that patients can consider signing up for."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy
2015. "Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02573766.
All > Pain Management > Pain
~4 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top