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

NCT02366611 | Completed Results FDA Device

• 2 other identifiers: HUM 78942U036889
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of Head and Neck

Keywords

Cancer Pain; EEG; fNIRS; tDCS

Outcome Measures

Primary Outcomes (3)

• 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: * 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.

  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: * 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.

  Pre/Post-tDCS Session

Secondary Outcomes (5)

• Oral-Mucositis Weekly Evaluation - Overall

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

• Patient Weight

  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

  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

  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

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

Study Arms (2)

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.

Device: Transcranial Direct Current Stimulation (tDCS)

Chemoradiotherapy Standard of Care

NO INTERVENTION

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

Interventions

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.

Transcranial Direct Current Stimulation (tDCS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Cancer Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

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.

Results Point of Contact

• Title: Alexandre DaSilva
• Organization: University of Michigan, School of Dentistry

adasilva@umich.edu

7346153807

Study Officials

• Alexandre DaSilva, DDS, DMedSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: February 19, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Locations

US (1)