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tDCS is a method of non-invasive brain stimulation that is based on the application of a weak direct current to the head that flows between two relatively large electrodes-anode and cathode. tDCS offers a unique analgesic modality of central pain neuromodulation by altering the activity of key sensory and motor cortical structures. Participants in this arm will undergo 20 tDCS sessions, tDCS in clinic and remotely supervised tDCS, and 2mA of transcranial direct current stimulation will be applied for 20 minutes.

The control group will consist of patients receiving the Standard of care and no neuromodulation.

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.

Transcranial Direct Current Stimulation (tDCS)

Alexandre DaSilva, DDS, DMedSc

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).

Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer

Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Locally Advanced Head and Neck Cancer

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.

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.

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.

1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor.

Participant's weight each measurement time point. Note: 0 means data missing.

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).

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.

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.

University of Michigan

Assistant Professor

tDCS is a method of non-invasive brain stimulation that is based on the application of a weak direct current to the head that flows between two relatively large electrodes-anode and cathode. tDCS offers a unique analgesic modality of central pain neuromodulation by altering the activity of key sensory and motor cortical structures. Participants in this arm will undergo 20 tDCS sessions, tDCS in clinic and remotely supervised tDCS, and 2mA of transcranial direct current stimulation will be applied for 20 minutes.

Transcranial Direct Current Stimulation (tDCS): 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.

Chemoradiotherapy Standard of Care

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

First, the patient number recruited in the current protocol was small, leading to difficulties in statistics across patients; Second, MRI scanning information did not accompany EEG data for clustering analysis.

Alexandre DaSilva

Pre Study

Week1

Week2

Week3

Week4

Week5

Week6

Week7

Follow Up Week 1

Follow Up Month 1

Visual Analog Scale (VAS)

Delta_Week1_P3

Theta_Week1_P3

Alpha_Week1_P3

Beta_Week1_P3

Gamma_Week1_P3

Delta_Week7_P3

Theta_Week7_P3

Alpha_Week7_P3

Beta_Week7_P3

Gamma_Week7_P3

Delta_Week1_Fz

Theta_Week1_Fz

Alpha_Week1_Fz

Beta_Week1_Fz

Gamma_Week1_Fz

Delta_Week7_Fz

Theta_Week7_Fz

Alpha_Week7_Fz

Beta_Week7_Fz

Gamma_Week7_Fz

Delta_Week1_Cz

Theta_Week1_Cz

Alpha_Week1_Cz

Beta_Week1_Cz

Gamma_Week1_Cz

Delta_Week7_Cz

Theta_Week7_Cz

Alpha_Week7_Cz

Beta_Week7_Cz

Gamma_Week7_Cz

Delta_Week1_F3

Theta_Week1_F3

Alpha_Week1_F3

Beta_Week1_F3

Gamma_Week1_F3

Delta_Week7_F3

Theta_Week7_F3

Alpha_Week7_F3

Beta_Week7_F3

Gamma_Week7_F3

Delta_Week1_Fp1

Theta_Week1_Fp1

Alpha_Week1_Fp1

Beta_Week1_Fp1

Gamma_Week1_Fp1

Delta_Week7_Fp1

Theta_Week7_Fp1

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Beta_Week7_Fp1

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Delta_Week1_Fp2

Theta_Week1_Fp2

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Beta_Week1_Fp2

Gamma_Week1_Fp2

Delta_Week7_Fp2

Theta_Week7_Fp2

Alpha_Week7_Fp2

Beta_Week7_Fp2

Gamma_Week7_Fp2

The control group will consist of patients receiving the standard of care and no neuromodulation.

EEG Power Spectrum Week1/Week7

Delta_Pre_P3

Theta_Pre_P3

Alpha_Pre_P3

Beta_Pre_P3

Gamma_Pre_P3

Delta_Post_P3

Theta_Post_P3

Alpha_Post_P3

Beta_Post_P3

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Delta_Pre_Fz

Theta_Pre_Fz

Alpha_Pre_Fz

Beta_Pre_Fz

Gamma_Pre_Fz

Delta_Post_Fz

Theta_Post_Fz

Alpha_Post_Fz

Beta_Post_Fz

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Delta_Pre_Cz

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Beta_Pre_Cz

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Delta_Post_Cz

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Delta_Pre_F3

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Delta_Post_F3

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Alpha_Post_F3

Beta_Post_F3

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Delta_Pre_Fp1

Theta_Pre_Fp1

Alpha_Pre_Fp1

Beta_Pre_Fp1

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Delta_Post_Fp1

Theta_Post_Fp1

Alpha_Post_Fp1

Beta_Post_Fp1

Gamma_Post_Fp1

Delta_Pre_Fp2

Theta_Pre_Fp2

Alpha_Pre_Fp2

Beta_Pre_Fp2

Gamma_Pre_Fp2

Delta_Post_Fp2

Theta_Post_Fp2

Alpha_Post_Fp2

Beta_Post_Fp2

Gamma_Post_Fp2

Because this piece of result compared EEG data pre- and post- tDCS stimulation, however the control (regular CRT) arm was not stimulated, thus the data were not collected and presented below.

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Spots Global Cancer Trial Database for fnirs

Every month we try and update this database with for fnirs cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fnirs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.