Ensayos clínicos

Inclusion Criteria:

• Male or female ages 21+
• At least 3 months post-radiation therapy for head & neck cancer
• Treatment for their cancer can include chemotherapy.

• Surgery for their cancer, if done, must meet these criteria:

  • diagnostic biopsy
  • less than ½ of oral tongue resected
  • less than ½ of tongue base resected
  • no floor of mouth muscles resected
  • less than 50% of any other part of the oral cavity, pharynx or larynx resected
  • no resection of hyoid
  • Neck dissection, unilateral or bilateral neck dissections may have been completed prior to or after radiation therapy.
• Currently free of cancer, confirmed by head and neck exam within 2 months of beginning the study
• MBS demonstrates penetration or aspiration on at least one swallow during the study (minimum PAS = 4)
• The patient is free of any medical conditions that could limit the patient's ability to follow the protocol.
• No history of any swallowing problems prior to the onset of head and neck cancer
• Prior swallow therapy, if given to the patient, is neither an Inclusion nor Exclusion criteria

Exclusion Criteria:

• Inability to cooperate with the examination and treatment.
• An implanted electrical device (e.g., pacemaker, deep brain stimulator, defibrillator, vagal nerve stimulator)
• Previous e-stim treatment to the head & neck
• Any current or previous neurological disease which may adversely affect swallowing.
• History of oropharyngeal swallowing disorder prior to cancer.
• History of pre-cancer oral intake that was limited due to a swallowing problem.
• Previous neurosurgery on the brain that could compromise swallowing or ability to follow protocol.
• Severe COPD (oxygen dependent).
• Need for dilation of the upper esophageal sphincter or esophagus at time of entry.
• Females who are currently pregnant will be excluded from participation.
• Females of childbearing potential must have a negative pregnancy test and must be practicing a medically accepted means of contraception (including, but not limited to, condoms, diaphragms/caps, contraceptive pills, contraceptive rings/patches, intrauterine devices, hysterectomy or abstinence)