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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

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.

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.

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

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I am 18 years old or older.

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I am able to care for myself and perform daily activities.

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My pain level is 4 or higher, or I have severe nerve pain.

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I have been experiencing nerve pain for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active brain metastases or severe brain disorders.

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I have been diagnosed with bipolar disorder or schizophrenia.

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I am currently taking antipsychotic medication.

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I have nerve damage not caused by chemotherapy.

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I have had a head injury or seizures in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electroencephalogram

2012

N/A

~150

Pain Scale

2017

Completed Phase 4