Trial Outcomes & Findings for Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer (NCT NCT02366611)

NCT ID: NCT02366611

Last Updated: 2021-01-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

Results posted on

2021-01-22

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Chemoradiotherapy Standard of Care
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Overall Study
STARTED
10
1
Overall Study
COMPLETED
8
1
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Transcranial Direct Current Stimulation (tDCS)
n=10 Participants
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
n=1 Participants
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Total
n=11 Participants
Total of all reporting groups
Age, Continuous
60.3 years
STANDARD_DEVIATION 8.1 • n=10 Participants
58 years
STANDARD_DEVIATION NA • n=1 Participants
60.1 years
STANDARD_DEVIATION 7.7 • n=11 Participants
Sex: Female, Male
Female
2 Participants
n=10 Participants
0 Participants
n=1 Participants
2 Participants
n=11 Participants
Sex: Female, Male
Male
8 Participants
n=10 Participants
1 Participants
n=1 Participants
9 Participants
n=11 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

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.

Outcome measures

Outcome measures
Measure
Transcranial Direct Current Stimulation (tDCS)
n=7 Participants
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
n=1 Participants
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Visual Analog Scale (VAS)
Pre Study
16 score on a scale
Standard Deviation 22
2 score on a scale
Visual Analog Scale (VAS)
Week1
11 score on a scale
Standard Deviation 14
0 score on a scale
Visual Analog Scale (VAS)
Week2
11 score on a scale
Standard Deviation 14
0 score on a scale
Visual Analog Scale (VAS)
Week3
25 score on a scale
Standard Deviation 19
0 score on a scale
Visual Analog Scale (VAS)
Week4
34 score on a scale
Standard Deviation 31
0 score on a scale
Visual Analog Scale (VAS)
Week5
32 score on a scale
Standard Deviation 28
0 score on a scale
Visual Analog Scale (VAS)
Week6
40 score on a scale
Standard Deviation 19
0 score on a scale
Visual Analog Scale (VAS)
Week7
36 score on a scale
Standard Deviation 18
0 score on a scale
Visual Analog Scale (VAS)
Follow Up Week 1
29 score on a scale
Standard Deviation 19
0 score on a scale
Visual Analog Scale (VAS)
Follow Up Month 1
31 score on a scale
Standard Deviation 15
0 score on a scale

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Transcranial Direct Current Stimulation (tDCS)
n=4 Participants
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
n=1 Participants
The control group will consist of patients receiving the Standard of care and no neuromodulation.
EEG Power Spectrum Week1/Week7
Gamma_Week1_Fp2
108.7 Power(10*log10(muV))^2
Standard Deviation 0.2
52.6 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week7_Fp2
129.1 Power(10*log10(muV))^2
Standard Deviation 3.1
127.6 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week7_Fp2
123.0 Power(10*log10(muV))^2
Standard Deviation 1.6
91.7 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week7_Fp2
119.0 Power(10*log10(muV))^2
Standard Deviation 1.4
79 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week7_Fp2
111.4 Power(10*log10(muV))^2
Standard Deviation 2.1
67.9 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week7_Fp2
106.6 Power(10*log10(muV))^2
Standard Deviation 1.1
56.9 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week1_P3
118.9 Power(10*log10(muV))^2
Standard Deviation 2.4
111 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week1_P3
115.3 Power(10*log10(muV))^2
Standard Deviation 0.3
86.9 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week1_P3
115.4 Power(10*log10(muV))^2
Standard Deviation 0.5
74 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week1_P3
114.2 Power(10*log10(muV))^2
Standard Deviation 0.2
61.6 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week1_P3
115 Power(10*log10(muV))^2
Standard Deviation 0.3
50.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week7_P3
129.5 Power(10*log10(muV))^2
Standard Deviation 3.3
127.6 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week7_P3
123.5 Power(10*log10(muV))^2
Standard Deviation 1.5
91.7 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week7_P3
118.3 Power(10*log10(muV))^2
Standard Deviation 1.8
78.9 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week7_P3
112.0 Power(10*log10(muV))^2
Standard Deviation 2.0
66.9 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week7_P3
107.4 Power(10*log10(muV))^2
Standard Deviation 1.0
55.4 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week1_Fz
118.6 Power(10*log10(muV))^2
Standard Deviation 2.8
126.4 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week1_Fz
114.7 Power(10*log10(muV))^2
Standard Deviation 0.2
90.5 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week1_Fz
113.3 Power(10*log10(muV))^2
Standard Deviation 1.4
77.5 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week1_Fz
110.8 Power(10*log10(muV))^2
Standard Deviation 0.2
64.5 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week1_Fz
111.7 Power(10*log10(muV))^2
Standard Deviation 0.4
51.3 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week7_Fz
146.7 Power(10*log10(muV))^2
Standard Deviation 2.9
127.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week7_Fz
141.9 Power(10*log10(muV))^2
Standard Deviation 1.6
91.2 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week7_Fz
137.1 Power(10*log10(muV))^2
Standard Deviation 1.7
78.6 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week7_Fz
129.3 Power(10*log10(muV))^2
Standard Deviation 2.1
68.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week7_Fz
124.0 Power(10*log10(muV))^2
Standard Deviation 1.2
57.6 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week1_Cz
117.9 Power(10*log10(muV))^2
Standard Deviation 2.5
125.5 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week1_Cz
114.3 Power(10*log10(muV))^2
Standard Deviation 0.2
89.6 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week1_Cz
113.3 Power(10*log10(muV))^2
Standard Deviation 1.3
76.5 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week1_Cz
110.7 Power(10*log10(muV))^2
Standard Deviation 0.3
63.7 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week1_Cz
111.4 Power(10*log10(muV))^2
Standard Deviation 0.3
51 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week7_Cz
141.7 Power(10*log10(muV))^2
Standard Deviation 3.1
126.5 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week7_Cz
136.5 Power(10*log10(muV))^2
Standard Deviation 1.6
90.6 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week7_Cz
132.3 Power(10*log10(muV))^2
Standard Deviation 1.5
77.9 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week7_Cz
123.8 Power(10*log10(muV))^2
Standard Deviation 2.5
67.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week7_Cz
118.3 Power(10*log10(muV))^2
Standard Deviation 1.1
56.4 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week1_F3
118.6 Power(10*log10(muV))^2
Standard Deviation 3.2
125.9 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week1_F3
114.1 Power(10*log10(muV))^2
Standard Deviation 0.3
90 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week1_F3
113.1 Power(10*log10(muV))^2
Standard Deviation 1.1
77 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week1_F3
110.7 Power(10*log10(muV))^2
Standard Deviation 0.4
64 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week1_F3
111.1 Power(10*log10(muV))^2
Standard Deviation 0.3
49.8 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week7_F3
140.3 Power(10*log10(muV))^2
Standard Deviation 3.7
129.5 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week7_F3
133.9 Power(10*log10(muV))^2
Standard Deviation 1.2
94.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week7_F3
127.7 Power(10*log10(muV))^2
Standard Deviation 2.1
81.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week7_F3
121.3 Power(10*log10(muV))^2
Standard Deviation 2.1
69.4 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week7_F3
116.1 Power(10*log10(muV))^2
Standard Deviation 1.2
57.2 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week1_Fp1
119.0 Power(10*log10(muV))^2
Standard Deviation 4.1
130 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week1_Fp1
113.0 Power(10*log10(muV))^2
Standard Deviation 0.5
94.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week1_Fp1
110.9 Power(10*log10(muV))^2
Standard Deviation 1.5
81.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week1_Fp1
109.0 Power(10*log10(muV))^2
Standard Deviation 0.2
68.3 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week1_Fp1
109.0 Power(10*log10(muV))^2
Standard Deviation 0.2
53.1 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week7_Fp1
132.3 Power(10*log10(muV))^2
Standard Deviation 2.9
129.5 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week7_Fp1
127.3 Power(10*log10(muV))^2
Standard Deviation 1.6
93.2 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week7_Fp1
122.6 Power(10*log10(muV))^2
Standard Deviation 1.5
80.3 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week7_Fp1
114.5 Power(10*log10(muV))^2
Standard Deviation 2.2
68.3 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Gamma_Week7_Fp1
109.3 Power(10*log10(muV))^2
Standard Deviation 1.1
56 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Delta_Week1_Fp2
120.4 Power(10*log10(muV))^2
Standard Deviation 3.8
128.8 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Theta_Week1_Fp2
115.0 Power(10*log10(muV))^2
Standard Deviation 0.5
92.9 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Alpha_Week1_Fp2
112.4 Power(10*log10(muV))^2
Standard Deviation 1.5
80 Power(10*log10(muV))^2
EEG Power Spectrum Week1/Week7
Beta_Week1_Fp2
108.8 Power(10*log10(muV))^2
Standard Deviation 0.7
67.2 Power(10*log10(muV))^2

PRIMARY outcome

Timeframe: Pre/Post-tDCS Session

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Transcranial Direct Current Stimulation (tDCS)
n=5 Participants
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
The control group will consist of patients receiving the Standard of care and no neuromodulation.
EEG Spectrum Pre-Post tDCS Session
Theta_Pre_F3
111.4 Power(10*log10(muV))^2
Standard Deviation 0.4
EEG Spectrum Pre-Post tDCS Session
Delta_Pre_F3
115.7 Power(10*log10(muV))^2
Standard Deviation 2.8
EEG Spectrum Pre-Post tDCS Session
Delta_Pre_P3
114.8 Power(10*log10(muV))^2
Standard Deviation 2.3
EEG Spectrum Pre-Post tDCS Session
Theta_Pre_P3
111.0 Power(10*log10(muV))^2
Standard Deviation 0.2
EEG Spectrum Pre-Post tDCS Session
Alpha_Pre_P3
109.8 Power(10*log10(muV))^2
Standard Deviation 1.1
EEG Spectrum Pre-Post tDCS Session
Beta_Pre_P3
105.9 Power(10*log10(muV))^2
Standard Deviation 1.0
EEG Spectrum Pre-Post tDCS Session
Gamma_Pre_P3
104.5 Power(10*log10(muV))^2
Standard Deviation 0.1
EEG Spectrum Pre-Post tDCS Session
Delta_Post_P3
115.6 Power(10*log10(muV))^2
Standard Deviation 2.6
EEG Spectrum Pre-Post tDCS Session
Theta_Post_P3
112.2 Power(10*log10(muV))^2
Standard Deviation 0.4
EEG Spectrum Pre-Post tDCS Session
Alpha_Post_P3
111.9 Power(10*log10(muV))^2
Standard Deviation 1.2
EEG Spectrum Pre-Post tDCS Session
Beta_Post_P3
109 Power(10*log10(muV))^2
Standard Deviation 0.4
EEG Spectrum Pre-Post tDCS Session
Gamma_Post_P3
108.8 Power(10*log10(muV))^2
Standard Deviation 0.2
EEG Spectrum Pre-Post tDCS Session
Delta_Pre_Fz
115.4 Power(10*log10(muV))^2
Standard Deviation 2.4
EEG Spectrum Pre-Post tDCS Session
Theta_Pre_Fz
111.4 Power(10*log10(muV))^2
Standard Deviation 0.3
EEG Spectrum Pre-Post tDCS Session
Alpha_Pre_Fz
109.1 Power(10*log10(muV))^2
Standard Deviation 1.5
EEG Spectrum Pre-Post tDCS Session
Beta_Pre_Fz
104.7 Power(10*log10(muV))^2
Standard Deviation 1.1
EEG Spectrum Pre-Post tDCS Session
Gamma_Pre_Fz
103.1 Power(10*log10(muV))^2
Standard Deviation 0.1
EEG Spectrum Pre-Post tDCS Session
Delta_Post_Fz
115.3 Power(10*log10(muV))^2
Standard Deviation 2.6
EEG Spectrum Pre-Post tDCS Session
Theta_Post_Fz
111.7 Power(10*log10(muV))^2
Standard Deviation 0.3
EEG Spectrum Pre-Post tDCS Session
Alpha_Post_Fz
110 Power(10*log10(muV))^2
Standard Deviation 1.6
EEG Spectrum Pre-Post tDCS Session
Beta_Post_Fz
106.7 Power(10*log10(muV))^2
Standard Deviation 0.5
EEG Spectrum Pre-Post tDCS Session
Gamma_Post_Fz
106.3 Power(10*log10(muV))^2
Standard Deviation 0.2
EEG Spectrum Pre-Post tDCS Session
Delta_Pre_Cz
115.9 Power(10*log10(muV))^2
Standard Deviation 2.2
EEG Spectrum Pre-Post tDCS Session
Theta_Pre_Cz
112.1 Power(10*log10(muV))^2
Standard Deviation 0.3
EEG Spectrum Pre-Post tDCS Session
Alpha_Pre_Cz
110 Power(10*log10(muV))^2
Standard Deviation 1.3
EEG Spectrum Pre-Post tDCS Session
Beta_Pre_Cz
105.8 Power(10*log10(muV))^2
Standard Deviation 1.1
EEG Spectrum Pre-Post tDCS Session
Gamma_Pre_Cz
103.9 Power(10*log10(muV))^2
Standard Deviation 0.1
EEG Spectrum Pre-Post tDCS Session
Delta_Post_Cz
116.4 Power(10*log10(muV))^2
Standard Deviation 2.5
EEG Spectrum Pre-Post tDCS Session
Theta_Post_Cz
112.9 Power(10*log10(muV))^2
Standard Deviation 0.2
EEG Spectrum Pre-Post tDCS Session
Alpha_Post_Cz
111.3 Power(10*log10(muV))^2
Standard Deviation 1.4
EEG Spectrum Pre-Post tDCS Session
Beta_Post_Cz
107.4 Power(10*log10(muV))^2
Standard Deviation 0.8
EEG Spectrum Pre-Post tDCS Session
Gamma_Post_Cz
106.5 Power(10*log10(muV))^2
Standard Deviation 0.2
EEG Spectrum Pre-Post tDCS Session
Alpha_Pre_F3
109.3 Power(10*log10(muV))^2
Standard Deviation 1.2
EEG Spectrum Pre-Post tDCS Session
Beta_Pre_F3
105.6 Power(10*log10(muV))^2
Standard Deviation 0.8
EEG Spectrum Pre-Post tDCS Session
Gamma_Pre_F3
104.3 Power(10*log10(muV))^2
Standard Deviation 0.1
EEG Spectrum Pre-Post tDCS Session
Delta_Post_F3
115.9 Power(10*log10(muV))^2
Standard Deviation 2.8
EEG Spectrum Pre-Post tDCS Session
Theta_Post_F3
112 Power(10*log10(muV))^2
Standard Deviation 0.2
EEG Spectrum Pre-Post tDCS Session
Alpha_Post_F3
110.4 Power(10*log10(muV))^2
Standard Deviation 1.4
EEG Spectrum Pre-Post tDCS Session
Beta_Post_F3
107.8 Power(10*log10(muV))^2
Standard Deviation 0.3
EEG Spectrum Pre-Post tDCS Session
Gamma_Post_F3
107.6 Power(10*log10(muV))^2
Standard Deviation 0.2
EEG Spectrum Pre-Post tDCS Session
Delta_Pre_Fp1
115.5 Power(10*log10(muV))^2
Standard Deviation 3.0
EEG Spectrum Pre-Post tDCS Session
Theta_Pre_Fp1
110.8 Power(10*log10(muV))^2
Standard Deviation 0.4
EEG Spectrum Pre-Post tDCS Session
Alpha_Pre_Fp1
108.4 Power(10*log10(muV))^2
Standard Deviation 1.4
EEG Spectrum Pre-Post tDCS Session
Beta_Pre_Fp1
104.6 Power(10*log10(muV))^2
Standard Deviation 0.9
EEG Spectrum Pre-Post tDCS Session
Gamma_Pre_Fp1
103 Power(10*log10(muV))^2
Standard Deviation 0.1
EEG Spectrum Pre-Post tDCS Session
Delta_Post_Fp1
114.8 Power(10*log10(muV))^2
Standard Deviation 2.8
EEG Spectrum Pre-Post tDCS Session
Theta_Post_Fp1
110.9 Power(10*log10(muV))^2
Standard Deviation 0.3
EEG Spectrum Pre-Post tDCS Session
Alpha_Post_Fp1
109.0 Power(10*log10(muV))^2
Standard Deviation 1.6
EEG Spectrum Pre-Post tDCS Session
Beta_Post_Fp1
105.7 Power(10*log10(muV))^2
Standard Deviation 0.5
EEG Spectrum Pre-Post tDCS Session
Gamma_Post_Fp1
105.1 Power(10*log10(muV))^2
Standard Deviation 0.1
EEG Spectrum Pre-Post tDCS Session
Delta_Pre_Fp2
114.9 Power(10*log10(muV))^2
Standard Deviation 2.7
EEG Spectrum Pre-Post tDCS Session
Theta_Pre_Fp2
110.4 Power(10*log10(muV))^2
Standard Deviation 0.4
EEG Spectrum Pre-Post tDCS Session
Alpha_Pre_Fp2
108 Power(10*log10(muV))^2
Standard Deviation 1.5
EEG Spectrum Pre-Post tDCS Session
Beta_Pre_Fp2
104 Power(10*log10(muV))^2
Standard Deviation 0.9
EEG Spectrum Pre-Post tDCS Session
Gamma_Pre_Fp2
102.4 Power(10*log10(muV))^2
Standard Deviation 0.1
EEG Spectrum Pre-Post tDCS Session
Delta_Post_Fp2
114.8 Power(10*log10(muV))^2
Standard Deviation 3.0
EEG Spectrum Pre-Post tDCS Session
Theta_Post_Fp2
110.7 Power(10*log10(muV))^2
Standard Deviation 0.2
EEG Spectrum Pre-Post tDCS Session
Alpha_Post_Fp2
108.9 Power(10*log10(muV))^2
Standard Deviation 1.5
EEG Spectrum Pre-Post tDCS Session
Beta_Post_Fp2
105.9 Power(10*log10(muV))^2
Standard Deviation 0.4
EEG Spectrum Pre-Post tDCS Session
Gamma_Post_Fp2
105.2 Power(10*log10(muV))^2
Standard Deviation 0.1

SECONDARY outcome

Timeframe: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

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

Outcome measures

Outcome measures
Measure
Transcranial Direct Current Stimulation (tDCS)
n=7 Participants
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
n=1 Participants
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Oral-Mucositis Weekly Evaluation - Overall
Pre-Study
4.9 score on a scale
Standard Deviation 1.1
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
Week1
5 score on a scale
Standard Deviation 1
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
Week2
4.8 score on a scale
Standard Deviation 1.5
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
Week3
4.6 score on a scale
Standard Deviation 1.2
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
Week4
4.9 score on a scale
Standard Deviation 0.6
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
Week5
4.7 score on a scale
Standard Deviation 0.7
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
Week6
4.7 score on a scale
Standard Deviation 0.7
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
Week7
4.9 score on a scale
Standard Deviation 0.8
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
FollowUp-Week1
4.5 score on a scale
Standard Deviation 1
7 score on a scale
Oral-Mucositis Weekly Evaluation - Overall
FollowUp-Month1
4.6 score on a scale
Standard Deviation 0.9
7 score on a scale

SECONDARY outcome

Timeframe: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

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

Outcome measures

Outcome measures
Measure
Transcranial Direct Current Stimulation (tDCS)
n=7 Participants
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
n=1 Participants
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Patient Weight
Week5
218.7 pound
Standard Deviation 38.4
133 pound
Patient Weight
Pre-Study
229.2 pound
Standard Deviation 40.6
136.5 pound
Patient Weight
Week1
224.2 pound
Standard Deviation 42.0
140 pound
Patient Weight
Week2
246.2 pound
Standard Deviation 33.2
139.3 pound
Patient Weight
Week3
221.9 pound
Standard Deviation 38.5
137.5 pound
Patient Weight
Week4
222.8 pound
Standard Deviation 41.6
140.6 pound
Patient Weight
Week6
210.7 pound
Standard Deviation 37.8
132.8 pound
Patient Weight
Week7
212.6 pound
Standard Deviation 37.6
131.9 pound
Patient Weight
FollowUp-Week1
220.8 pound
Standard Deviation 27.5
132 pound
Patient Weight
FollowUp-Month1
206.2 pound
Standard Deviation 35.5
127.9 pound

SECONDARY outcome

Timeframe: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

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).

Outcome measures

Outcome measures
Measure
Transcranial Direct Current Stimulation (tDCS)
n=7 Participants
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
n=1 Participants
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Positive and Negative Affect Schedule
GP-PRE-PreStudy
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-PRE-Week1
19 score on a scale
Standard Deviation 16
37 score on a scale
Positive and Negative Affect Schedule
GP-PRE-Week2
16 score on a scale
Standard Deviation 19
39 score on a scale
Positive and Negative Affect Schedule
GP-PRE-Week3
11 score on a scale
Standard Deviation 19
38 score on a scale
Positive and Negative Affect Schedule
GP-PRE-Week4
18 score on a scale
Standard Deviation 16
39 score on a scale
Positive and Negative Affect Schedule
GP-PRE-Week5
18 score on a scale
Standard Deviation 16
30 score on a scale
Positive and Negative Affect Schedule
GP-PRE-Week6
23 score on a scale
Standard Deviation 13
34 score on a scale
Positive and Negative Affect Schedule
GP-PRE-Week7
10 score on a scale
Standard Deviation 17
37 score on a scale
Positive and Negative Affect Schedule
GP-PRE-FollowupWeek1
21 score on a scale
Standard Deviation 15
35 score on a scale
Positive and Negative Affect Schedule
GP-PRE-FollowupMonth1
30 score on a scale
Standard Deviation 10
38 score on a scale
Positive and Negative Affect Schedule
GN-PRE-PreStudy
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-PRE-Week1
9 score on a scale
Standard Deviation 8
13 score on a scale
Positive and Negative Affect Schedule
GN-PRE-Week2
7 score on a scale
Standard Deviation 9
10 score on a scale
Positive and Negative Affect Schedule
GN-PRE-Week3
4 score on a scale
Standard Deviation 8
10 score on a scale
Positive and Negative Affect Schedule
GN-PRE-Week4
10 score on a scale
Standard Deviation 6
10 score on a scale
Positive and Negative Affect Schedule
GN-PRE-Week5
9 score on a scale
Standard Deviation 6
10 score on a scale
Positive and Negative Affect Schedule
GN-PRE-Week6
11 score on a scale
Standard Deviation 5
10 score on a scale
Positive and Negative Affect Schedule
GN-PRE-Week7
5 score on a scale
Standard Deviation 9
10 score on a scale
Positive and Negative Affect Schedule
GN-PRE-FollowupWeek1
10 score on a scale
Standard Deviation 7
10 score on a scale
Positive and Negative Affect Schedule
GN-PRE-FollowupMonth1
14 score on a scale
Standard Deviation 5
10 score on a scale
Positive and Negative Affect Schedule
GP-POST-PreStudy
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-Week1
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-Week2
14 score on a scale
Standard Deviation 12
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-Week3
14 score on a scale
Standard Deviation 14
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-Week4
14 score on a scale
Standard Deviation 10
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-Week5
14 score on a scale
Standard Deviation 10
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-Week6
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-Week7
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-FollowupWeek1
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GP-POST-FollowupMonth1
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-PreStudy
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-Week1
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-Week2
13 score on a scale
Standard Deviation 12
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-Week3
14 score on a scale
Standard Deviation 10
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-Week4
13 score on a scale
Standard Deviation 10
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-Week5
14 score on a scale
Standard Deviation 10
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-Week6
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-Week7
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-FollowupWeek1
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.
Positive and Negative Affect Schedule
GN-POST-FollowupMonth1
NA score on a scale
Standard Deviation NA
Data were not collected at the time point.
NA score on a scale
Data were not collected at the time point.

SECONDARY outcome

Timeframe: Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment)

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.

Outcome measures

Outcome measures
Measure
Transcranial Direct Current Stimulation (tDCS)
n=7 Participants
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
n=1 Participants
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Washington Quality Of Life Questionnaire
Pre-Study
18.6 score on a scale
Standard Deviation 8.3
20 score on a scale
Washington Quality Of Life Questionnaire
Week7
34.3 score on a scale
Standard Deviation 4.9
10 score on a scale
Washington Quality Of Life Questionnaire
FollowUp-Week1
31.7 score on a scale
Standard Deviation 6.9
10 score on a scale
Washington Quality Of Life Questionnaire
FollowUp-Month1
28.6 score on a scale
Standard Deviation 3.5
10 score on a scale

SECONDARY outcome

Timeframe: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-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.

Outcome measures

Outcome measures
Measure
Transcranial Direct Current Stimulation (tDCS)
n=7 Participants
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
n=1 Participants
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE Week5
1.8 score on a scale
Standard Deviation 1.5
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE Week6
1.8 score on a scale
Standard Deviation 0.7
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE Week7
1.8 score on a scale
Standard Deviation 0.9
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE FollowUp Week1
1.2 score on a scale
Standard Deviation 0.9
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE FollowUp Month1
1.7 score on a scale
Standard Deviation 0.7
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE Pre-Study
0.9 score on a scale
Standard Deviation 1.1
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE Week1
0.4 score on a scale
Standard Deviation 1.0
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE Week2
0.7 score on a scale
Standard Deviation 1.0
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE Week3
1.7 score on a scale
Standard Deviation 1.0
0 score on a scale
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
PPI PRE Week4
2.0 score on a scale
Standard Deviation 1.4
0 score on a scale

Adverse Events

Transcranial Direct Current Stimulation (tDCS)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Chemoradiotherapy Standard of Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alexandre DaSilva

University of Michigan, School of Dentistry

Phone: 7346153807

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place