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

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).

Inclusion Criteria:

- Patients with AJCC stage III-IV head and neck malignancy scheduled for definitive
radiation therapy or chemoradiotherapy, and who are capable of understanding and
adhering to the protocol requirements.

Exclusion Criteria:

- Substantial dementia

- Patients are actively being treated for another cancer at the time of enrollment.

- Any condition that would prevent use of tDCS including skull abnormality, implanted
metal, implanted electronic device, seizure disorder, neurologic condition.

- Use of an investigational drug or device within 30 days of study screening