Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U036889 | Other Identifier | UMichigan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | 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. |
|
| Chemoradiotherapy Standard of Care | No Intervention | The control group will consist of patients receiving the Standard of care and no neuromodulation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
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. | 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:
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. | Pre/Post-tDCS Session |
| Measure | Description | Time Frame |
|---|---|---|
| Oral-Mucositis Weekly Evaluation - Overall | 1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor. | Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) |
| Patient Weight |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexandre DaSilva, DDS, DMedSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Direct Current Stimulation (tDCS) | 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. |
| FG001 | Chemoradiotherapy Standard of Care | The control group will consist of patients receiving the Standard of care and no neuromodulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Direct Current Stimulation (tDCS) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) |
|
4 years, 11 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Direct Current Stimulation (tDCS) | 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandre DaSilva | University of Michigan, School of Dentistry | 7346153807 | adasilva@umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 21, 2019 | Sep 15, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2019 | Nov 22, 2020 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Participant's weight each measurement time point. Note: 0 means data missing. |
| 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). | 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. | 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. | Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) |
| BG001 | Chemoradiotherapy Standard of Care | The control group will consist of patients receiving the Standard of care and no neuromodulation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Chemoradiotherapy Standard of Care | The control group will consist of patients receiving the Standard of care and no neuromodulation. |
|
|
| Primary | 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:
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. | Posted | Mean | Standard Deviation | Power(10*log10(muV))^2 | Week1/Week7 |
|
|
|
| Primary | EEG Spectrum Pre-Post tDCS Session | EEG data power spectrum analysis. Pre/Post-tDCS session. The report was divided into five frequency bands:
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. | 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. | Posted | Mean | Standard Deviation | Power(10*log10(muV))^2 | Pre/Post-tDCS Session |
|
|
|
| Secondary | Oral-Mucositis Weekly Evaluation - Overall | 1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) |
|
|
|
| Secondary | Patient Weight | Participant's weight each measurement time point. Note: 0 means data missing. | Posted | Mean | Standard Deviation | pound | Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Chemoradiotherapy Standard of Care | The control group will consist of patients receiving the Standard of care and no neuromodulation. | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| 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 |
|
| Alpha_Week7_Fp1 |
|
| Beta_Week7_Fp1 |
|
| Gamma_Week7_Fp1 |
|
| Delta_Week1_Fp2 |
|
| Theta_Week1_Fp2 |
|
| Alpha_Week1_Fp2 |
|
| Beta_Week1_Fp2 |
|
| Gamma_Week1_Fp2 |
|
| Delta_Week7_Fp2 |
|
| Theta_Week7_Fp2 |
|
| Alpha_Week7_Fp2 |
|
| Beta_Week7_Fp2 |
|
| Gamma_Week7_Fp2 |
|
| Title | Measurements |
|---|---|
|
| Beta_Pre_P3 |
|
| Gamma_Pre_P3 |
|
| Delta_Post_P3 |
|
| Theta_Post_P3 |
|
| Alpha_Post_P3 |
|
| Beta_Post_P3 |
|
| Gamma_Post_P3 |
|
| 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 |
|
| Gamma_Post_Fz |
|
| Delta_Pre_Cz |
|
| Theta_Pre_Cz |
|
| Alpha_Pre_Cz |
|
| Beta_Pre_Cz |
|
| Gamma_Pre_Cz |
|
| Delta_Post_Cz |
|
| Theta_Post_Cz |
|
| Alpha_Post_Cz |
|
| Beta_Post_Cz |
|
| Gamma_Post_Cz |
|
| Delta_Pre_F3 |
|
| Theta_Pre_F3 |
|
| Alpha_Pre_F3 |
|
| Beta_Pre_F3 |
|
| Gamma_Pre_F3 |
|
| Delta_Post_F3 |
|
| Theta_Post_F3 |
|
| Alpha_Post_F3 |
|
| Beta_Post_F3 |
|
| Gamma_Post_F3 |
|
| Delta_Pre_Fp1 |
|
| Theta_Pre_Fp1 |
|
| Alpha_Pre_Fp1 |
|
| Beta_Pre_Fp1 |
|
| Gamma_Pre_Fp1 |
|
| 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 |
|
| Week2 |
|
| Week3 |
|
| Week4 |
|
| Week5 |
|
| Week6 |
|
| Week7 |
|
| FollowUp-Week1 |
|
| FollowUp-Month1 |
|
| Week2 |
|
| Week3 |
|
| Week4 |
|
| Week5 |
|
| Week6 |
|
| Week7 |
|
| FollowUp-Week1 |
|
| FollowUp-Month1 |
|
| GP-PRE-Week2 |
|
| GP-PRE-Week3 |
|
| GP-PRE-Week4 |
|
| GP-PRE-Week5 |
|
| GP-PRE-Week6 |
|
| GP-PRE-Week7 |
|
| GP-PRE-FollowupWeek1 |
|
| GP-PRE-FollowupMonth1 |
|
| GN-PRE-PreStudy |
|
| GN-PRE-Week1 |
|
| GN-PRE-Week2 |
|
| GN-PRE-Week3 |
|
| GN-PRE-Week4 |
|
| GN-PRE-Week5 |
|
| GN-PRE-Week6 |
|
| GN-PRE-Week7 |
|
| GN-PRE-FollowupWeek1 |
|
| GN-PRE-FollowupMonth1 |
|
| GP-POST-PreStudy |
|
| GP-POST-Week1 |
|
| GP-POST-Week2 |
|
| GP-POST-Week3 |
|
| GP-POST-Week4 |
|
| GP-POST-Week5 |
|
| GP-POST-Week6 |
|
| GP-POST-Week7 |
|
| GP-POST-FollowupWeek1 |
|
| GP-POST-FollowupMonth1 |
|
| GN-POST-PreStudy |
|
| GN-POST-Week1 |
|
| GN-POST-Week2 |
|
| GN-POST-Week3 |
|
| GN-POST-Week4 |
|
| GN-POST-Week5 |
|
| GN-POST-Week6 |
|
| GN-POST-Week7 |
|
| GN-POST-FollowupWeek1 |
|
| GN-POST-FollowupMonth1 |
|
| FollowUp-Week1 |
|
| FollowUp-Month1 |
|
| PPI PRE Week2 |
|
| PPI PRE Week3 |
|
| PPI PRE Week4 |
|
| PPI PRE Week5 |
|
| PPI PRE Week6 |
|
| PPI PRE Week7 |
|
| PPI PRE FollowUp Week1 |
|
| PPI PRE FollowUp Month1 |
|