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Behavioural Intervention
Neurofeedback for Head and Neck Cancer Pain
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 must not have pain > 2 on a scale of 0 - 10 (self report) in the head and neck before starting radiotherapy
Scheduled to undergo a 6 week course of radiotherapy for head and neck cancer
Must not have
Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy
Patients who are taking any antipsychotic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing neurofeedback training to see if it can help decrease pain caused by radiation therapy for head and neck cancer.
Who is the study for?
This trial is for English-speaking individuals with head and neck cancer, who are about to start a 6-week radiotherapy course and currently have low pain levels. They must consent to the study's protocol and not plan on changing their pain medication during the study. Those with chronic pain, mental health conditions like bipolar disorder or schizophrenia, seizure disorders, or active brain diseases cannot participate.
What is being tested?
The trial is testing neurofeedback training—a therapy that uses brain wave activity measurements to potentially reduce acute pain caused by radiotherapy in head and neck cancer patients. Participants will learn how to alter their own brain waves to lessen pain perception.
What are the potential side effects?
Since neurofeedback involves non-invasive brain activity monitoring and training without medications, it typically does not produce side effects. However, some participants might experience discomfort from wearing sensors or fatigue after sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My head or neck pain is 2 or less on a scale of 0 to 10.
Select...
I am set to start a 6-week radiotherapy for my head or neck cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have active brain metastases or severe brain disorders.
Select...
I am currently taking antipsychotic medication.
Select...
I have chronic pain in my head or neck that requires painkillers.
Select...
I have a history of seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
EEG
Neurofeeback (LORETA)
Secondary study objectives
Malignant Neoplasms
Pain medication use
The Brief Pain Inventory (Short Form)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (neurofeedback)Experimental Treatment2 Interventions
Beginning at weeks 4 and 5 or 5 and 6 of radiotherapy, patients undergo neurofeedback training QID TIW for up to 6 treatments. Patients also complete questionnaires over 10 minutes at baseline and after neurofeedback training.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,791 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,153 Total Patients Enrolled
Sarah PrinslooPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
833 Total Patients Enrolled
Lorenzo CohenPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
58,277 Total Patients Enrolled