Clinical trial: NCT02366611
Section: Alternatives
Subsections: 5.3 If I Take Part In This Study, Can I Also Participate In Other Studies?|6. Other Options

Being in more than one research study at the same time, or even at different times, may increase the risks to you. It may also affect the results of the studies. You should not take part in more than one study without approval from the researchers involved in each study.  
5.4 How could I benefit if I take part in this study? How could others benefit?  
You may not receive any personal benefits from being in this study other than to help advance scientific knowledge.  
Participants in this study may experience pain relief as a result of the tDCS treatments.  
However, it is possible that some participants will not have extended reduction of pain. We hope this will help us to better understand ways to treat chronic pain conditions.

6.1 If I decide not to take part in this study, what other options do I have?  
Your participation in this project is voluntary, and participation will not help in treatment or diagnosis of any medical condition. The alternative to experiencing these procedures is not to participate. You should feel free to choose or reject this study or to withdraw from any portion of this study at any time without penalty or loss of benefits to which you may otherwise be entitled. The physicians and other staff of the University Hospital will continue to offer their best medical care regardless of your decision. You may want to discuss additional treatment options with the study team or your current physicians.
Clinical trial: NCT02366611
Section: Confidentiality
Subsections: 9.1 How Will The Researchers Protect My Privacy?|9.3 What Happens To Information About Me After The Study Is Over Or If I Cancel My Permission?|9.4 When Does My Permission Expire?

We shall put the information collected about you during the study into a research record. This research record will not show your name, but will have codes entered in it, that will allow the information to be linked to you by the investigators. However, we shall keep your research record confidential, to the extent provided by federal, state and local law. We shall not allow anyone to see your record, other than people who have a right to see it. You will not be identified in any reports on this study. Nevertheless, the National Institutes of Health, the United States Federal Food and Drug Administration, and the Institutional Review Board monitoring this study may inspect the records of this investigation.  
9.2 What information about me could be seen by the researchers or by other people? Why? Who might see it?  
Signing this form gives the researchers your permission to obtain, use, and share information about you for this study, and is required in order for you to take part in the study. Information about you may be obtained from any hospital, doctor, and other health care provider involved in your care, including:
- Hospital/doctor's office records, including test results (X-rays, blood tests, urine tests, etc.) - All records relating to your condition, the treatment you have received, and your response to the treatment - Billing information There are many reasons why information about you may be used or seen by the researchers or others during or after this study. Examples include:
- The researchers may need the information to make sure you can take part in the study. - The researchers may need the information to check your test results or look for side effects. - University, Food and Drug Administration (FDA), and/or other government officials may need the information to make sure that the study is done in a safe and proper manner.  
- Study sponsors or funders, or safety monitors or committees, may need the information to:
o Make sure the study is done safely and properly o Learn more about side effects o Analyze the results of the study
- Insurance companies or other organizations may need the information in order to pay your medical bills or other costs of your participation in the study.  
- The researchers may need to use the information to create a databank of information about your condition or its treatment.  
- Information about your study participation may be included in your regular UMHS medical record.  
- If you receive any payments for taking part in this study, the University of Michigan accounting department may need your name, address, social security number, payment amount, and related information for tax reporting purposes.  
- Federal or State law may require the study team to give information to government agencies. For example, to prevent harm to you or others, or for public health reasons.  
The results of this study could be published in an article or presented at a scientific meeting, but would not include any information that would let others know who you are.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

As a rule, the researchers will not continue to use or disclose information about you, but will keep it secure until it is destroyed. Sometimes, it may be necessary for information about you to continue to be used or disclosed, even after you have canceled your permission or the study is over.  
Examples of reasons for this include:
- To avoid losing study results that have already included your information
- To provide limited information for research, education, or other activities (This information would not include your name, social security number, or anything else that could let others know who you are.)
- To help University and government officials make sure that the study was conducted properly As long as your information is kept within the University of Michigan Health System, it is protected by the Health System's privacy policies. For more information about these policies, ask for a copy of the University of Michigan
"Notice of Privacy Practices". This information is also available on the web at http://www.uofmhealth.org/patient+and+visitor+guide/hipaa. Note that once your information has been shared with others as described under Question 9.2, it may no longer be protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Your permission expires at the end of the study, unless you cancel it sooner. You may cancel your permission at any time by writing to the researchers listed in Section 10 "Contact Information" (below).
Clinical trial: NCT02366611
Section: Duration of Study Involvement
Subsections: 4.3 When Will My Participation In The Study Be Over?

After your chemoradiotherapy/radiation therapy treatment is complete, you will return for a one-month follow-up appointment, then every 2 months during years 1 and 2, and at 3-month intervals during year 3. Your participation in the study will **end after the one-month follow-up visit**.  
4.4 What will happen with my information and/or biospecimens used in this study?  
Your biospecimens and collected information may be shared with M-Cubed (a research program within the University of Michigan).  
With appropriate permissions, your biospecimens and collected information may also be shared with other researchers, here, around the world, and with companies.  
Your identifiable private information or identifiable biospecimens may be stripped of identifiers and used for future research studies or distributed to another researcher for future research studies without additional informed consent.
Clinical trial: NCT02366611
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 5. Information About Risks And Benefits|7.2 Could There Be Any Harm To Me If I Decide To Leave The Study Before It Is Finished?

5.1 What risks will I face by taking part in the study? What will **the researchers do to protect me against these**
risks? The known or expected risks are: 1) Loss of confidentiality around sensitive information:
To minimize risk: You will be assigned research numbers, and all research information collected will be linked to you only by this number. Great care is taken to remove all identifying information from research records. A single tracking file contains links to the research records and subject codes. Recruitment tracking files are kept only for the duration of the study. Paper records are kept in locked file drawers in a locked room, which only authorized research personnel have access. Paper records with identifying information (consent form, payment records) are kept in locked file cabinets, physically separate from the research records. Computer records with identifying information are kept on secure, password protected servers. Staff is trained to scrupulously protect the confidentiality of sensitive information, and take care to limit the printing of documents with identifying information and to avoid unnecessary discussion of subject names.

There is no inherent risk in leaving the study early.  
7.3 Could the researchers take me out of the study even if I want to continue to participate? Yes. There are many reasons why the researchers may need to end your participation in the study. Some examples are:
ü The researcher believes that it is not in your best interest to stay in the study. ü You become ineligible to participate.  
ü Your condition changes and you need treatment that is not allowed while you are taking part in the study.  
ü You do not follow instructions from the researchers.  
ü The study is suspended or canceled.
Clinical trial: NCT02366611
Section: Procedures
Subsections: 4. Information About Study Participation 4.1 What Will Happen To Me In This Study?

After your initial screening with your Radiation Oncologist, during which eligibility for the study was determined and you were provided with this Informed Consent document to sign, you will be referred to Hospital Dentistry for Evaluation and Clearance (this is performed for all patients as a standard of care). At this time a pre-study visit will be scheduled for before your chemoradiotherapy/radiation treatment begins. At the start of this visit you will be asked to sign the informed consent (if you have not done so already), and only after the informed consent is signed will you complete some questionnaires and an EEG and fNIRS recording will take place. After this appointment you will be randomized into one of the two Arms (those who receive just the Standard of Care, and those you receive the Standard of Care plus tDCS).  
You and/or your caregiver will receive on the first week, a proper training with a trained team member regarding remotely supervised tDCS and provided with a study stimulation device and guidelines. You will be real-time supervised via videoconference for these sessions. According to your decision, you can be treated either totally at the clinic tDCS sessions or combine at home tDCS
with at clinic tDCS sessions and can adjust the schedule of sessions (tDCS in clinic or RS-tDCS) at any moment during the study visits.  
Participants in both arms will complete the Oral Mucositis Quality of Life and Odynophagia Assessments each of the seven weeks of chemoradiotherapy/radiation therapy, and all pre-treatment surveys will be completed again at a one-week and one-month follow-up visit. Some intraoral (non-identifiable) photographs may be taken over the course of your treatment to help visualize areas of pain you may be experiencing from the chemoradiotherapy/radiation therapy. Trasncranial 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. You will participate in one tDCS trial, consisting of tDCS stimulation and surveys. The tDCS will occur on the day of your chemoradiotherapy/radiation therapy. This will last the seven weeks of your chemoradiotherapy/radiation therapy. We will combine remotely supervised tDCS sessions to facilitate participants' compliance and retention during multiple visits. You will participate in a total of 20 tDCS sessions, each lasting approximately 45-60 minutes, including examination, set-up, clean-up, pain/mood questionnaires, and a tDCS Side Effects Questionnaire. During each tDCS session, two electrodes will be placed on your head using a specialized cap. 2 mA of transcranial direct current stimulation will be applied for 20 minutes. Before, during and after select active tDCS sessions, EEG data will be recorded. In addition, two pain questionnaires and one mood questionnaire—Short-Form McGill Pain Questionnaire, HOPE Pain Assessment Form (GeoPain), and Positive and Negative Affect Schedule—will be completed before and after each tDCS session. If a stimulation appointment cannot be completed on a scheduled day, then two stimulations will take place the day before or following day. The first stimulation will be in the morning, and the second stimulation will take place in the afternoon.
Clinical trial: NCT02366611
Section: Purpose of Research
Subsections: 2. Purpose Of This Study 2.1 Study Purpose:

More than 50,000 Americans (and more than 750,000 people worldwide) are diagnosed with head and neck cancer
(HNCa) every year. HNCa impacts oral intake, speech, physical appearance, and emotional well-being. Despite advancements in treatment technology, which improves patient lifestyle and comfort, HNCa patient quality of life
(QoL) still suffers. Transcranial Direct Current Stimulation (tDCS) offers a unique pain-relief modality. It is a noninvasive brain stimulation technique, requiring users to wear a specially made cap, which allows for precise stimulation of specific brain areas. tDCS has been shown in other studies, performed by our lab and others, to be safe and effective in several chronic pain conditions, including fibromyalgia, chronic migraines, and multiple sclerosis. The aim of this study is to determine if tDCS can reduce pain perception associated with the effects of receiving chemoradiotherapy or radiation therapy in HNCa patients. As a participant in this study, you will be randomized (like flipping a coin) to one arm of the study or the other. Patients in Arm 1
(chemoradiotherapy/radiation therapy standard of care and tDCS) will receive the tDCS neuromodulation. Patients in Arm 2 (chemoradiotherapy/radiation therapy standard of care alone) will receive the standard of care. The addition of tDCS to your treatment will not affect how the tumor responds to the chemoradiotherapy/radiation therapy you receive, but it may reduce the pain you experience during your treatment.
Clinical trial: NCT02366611
Section: Voluntary Participation
Subsections: 3.1 Who Can Take Part In This Study?|Consent To Participate In The Research Study (Research Subject)

Patients, between the age of 18-75, with any AJCC stage head and neck malignancy, scheduled for definitive chemoradiotherapy or radiation therapy may participate in this study.  
Patients with substantial dementia, patients who are actively being treated for another cancer, or who have any condition that would prevent use of the tDCS (skull abnormality, implanted metal or electronic device, seizure disorder or other neurologic condition) may not fit the criteria for inclusion. Additionally, patients who have taken an investigational drug or device in the last 30 days may not participate.

I understand the information printed on this form. I have discussed this study, its risks and potential benefits, and my other choices with [NAME OF STUDY TEAM MEMBER OBTAINING CONSENT] ________________________. My questions so far have been answered. I understand that if I have more questions or concerns about the study or my participation as a research subject, I may contact one of the people listed in Section 10 (above). I
understand that I will receive a copy of this form at the time I sign it and later upon request. I understand that if my ability to consent or assent for myself changes, either I or my legal representative may be asked to reconsent prior to my continued participation in this study.  
Print Legal Name: ________________________________________________________________________
Signature: ______________________________________________________________________________
Date of Signature (mm/dd/yy): ____________________________
Clinical trial: NCT02366611
Section: Withdrawal from Study
Subsections: 5.5 Will The Researchers Tell Me If They Learn Of New Information That Could Change My Willingness To Stay In This Study?|7. Ending The Study 7.1 If I Want To Stop Participating In The Study, What Should I Do?

Yes, the researchers will tell you if they learn of important new information that may change your willingness to stay in this study. If new information is provided to you after you have joined the study, it is possible that you may be asked to sign a new consent form that includes the new information.

You are free to leave the study at any time. If you leave the study before it is finished, there will be no penalty to you. You will not lose any benefits to which you may otherwise be entitled. If you choose to tell the researchers why you are leaving the study, your reasons for leaving may be kept as part of the study record. If you decide to leave the study before it is finished, please tell one of the persons listed in Section 10 "Contact Information" (below).