The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS) can reduce pain perception associated with the effects of receiving definitive radiation therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.
The goal of this study is to investigate the effectiveness of tDCS as a novel pain relief modality for odynophagia due to mucositis in patients with locally advanced head and neck cancer undergoing definitive radiation therapy or chemoradiotherapy. Participants will be randomized into one of two arms: (1) Treatment: radiation/chemoradiotherapy standard of care + tDCS neuromodulation or (2) Control: radiation/chemoradiotherapy standard of care only. Patients in the treatment arm will undergo tDCS stimulation on the day of their radiation/chemoradiotherapy appointments, prior to receiving treatment when doing tDCS session in clinic or after to receiving treatment when doing tDCS session at home. This will occur daily (5 days per week) during the second and third weeks of therapy, three times per week during the fourth and fifth weeks, and twice per week during the sixth and seventh weeks. Patients will also have EEG and fNIRS recordings during the study. This will occur at the pre-study visit, the first stimulation appointment, the third week, the 7th week, and during the follow-up appointments (one-week and one-month).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
11
tDCS is a non-invasive brain neuromodulatory method that involves sending a weak electrical current to the brain. 2mA of tDCS will be applied for 20 minutes at each session and participants will undergo a total of 20 sessions over a 7-week period.
University of Michigan
Ann Arbor, Michigan, United States
Visual Analog Scale (VAS)
A Visual Analog Scale (VAS) will be used to assess patient-reported odynophagia at weekly Radiation Oncology on-treatment visits (OTVs). The VAS is a traditional pain assessment tool that has been used and validated widely in both clinical and research settings, including studies of oral mucositis pain. This scale ranges from 0-100, in which 0 means no odynophagia, and 100 means highest level of odynophagia ever.
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
EEG Power Spectrum Week1/Week7
EEG data power spectrum analysis. Week1 and Week 7 difference. Note: the control participant's data was not reported due to limited number of participant in the control group. The report was divided into five frequency bands: * Delta = 0-4 Hz * Theta = 4-7 Hz * Alpha = 8-15 Hz * Beta= 16-31 Hz * Gamma 32-50 Hz The data was recorded at P3, Fz, Cz, F3, Fp1, Fp2 points in the international 10-20 system. The analysis was done using EEGLab V 14.1.1.
Time frame: Week1/Week7
EEG Spectrum Pre-Post tDCS Session
EEG data power spectrum analysis. Pre/Post-tDCS session. The report was divided into five frequency bands: * Delta = 0-4 Hz * Theta = 4-7 Hz * Alpha = 8-15 Hz * Beta= 16-31 Hz * Gamma 32-50 Hz The data was recorded at P3, Fz, Cz, F3, Fp1, Fp2 points in the international 10-20 system. Note: the control participant's data was not reported due to limited number of participant in the control group.
Time frame: Pre/Post-tDCS Session
Oral-Mucositis Weekly Evaluation - Overall
1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor.
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
Patient Weight
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Participant's weight each measurement time point. Note: 0 means data missing.
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
Positive and Negative Affect Schedule
The General Positive and General Negative scores in the PANAS forms are reported for both pre- and post- treatment. The General Positive (GP) and General Negative (GN) scores were reported. Each score ranges from 10-50, in which 10 = lowest (positive/negative emotional level) and 50 = highest (positive/negative emotional level).
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
Washington Quality Of Life Questionnaire
The Washington Quality Of Life questionnaire (QOL) is one of the most frequently reported health-related QOL questionnaires in head and neck cancer. This questionnaire scaled from 0 (worst) to 100 (best) according to the hierarchy of response.
Time frame: Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment)
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
The Present Pain Intensity (PPI) index is recorded as a number ranges from 0 to 5, in which each number is associated with the following words: 0 no pain, 1 mild, 2 discomforting, 3 distressing, 4 horrible, 5 excruciating.
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)