BION Treatment of Dysphagia After Radical Head-Neck Surgery
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary goal of the proposed study is to improve the long-term swallowing capabilities of
      subjects undergoing radical or modified radical neck surgeries followed by chemoradiation
      therapy (CRT), by more selective stimulation of the swallowing muscles using implanted
      microstimulators called BIONs.
    

Detailed description: 
      Disseminated head and neck cancer is a serious, often life-threatening medical problem that
      requires immediate and heroic therapeutic intervention. Treatment typically begins with
      extensive surgery followed as soon as possible by an intense series of radiation and
      chemotherapy treatments. Typically the patient has recovered sufficiently from the surgery by
      2-4 weeks to withstand the new assaults that will result from chemoradiation therapy (CRT),
      which kills cancer cells, but also causes muscle atrophy and scarring that can permanently
      ruin the swallowing apparatus. Thus, the majority of patients who undergo CRT develop severe
      swallowing problems, called dysphagia, that typically becomes worse by about 3-4 weeks
      following the beginning of CRT. In anticipation of all of these problems, subjects have a
      tube placed in the stomach (gastrostomy tube) so that they can be fed through the tube in the
      immediate postoperative period when the incision is fragile and when dysphagia develops
      during CRT. Clearly the management of dysphagia during CRT is of primary importance to the
      prognosis of the patient. Recent studies have shown that electrical activation of swallowing
      muscles during and after CRT can improve the prognosis by reducing dysphagia, but currently
      available technology requires the current to be applied transcutaneously. Thus, large
      electrical currents must be applied to the damaged skin, and the electrical stimulation that
      results is uncomfortable, diffuse and uncontrolled. It is difficult with this approach to
      stimulate the deepest muscles that are the preferred targets for the stimulation. The primary
      goal of the proposed study is to improve the long-term swallowing capabilities of subjects
      undergoing radical or modified radical neck surgeries followed by CRT, by more selective
      stimulation of the swallowing muscles using implanted microstimulators called BIONs. The
      mechanism of the electrical stimulation is thought to be the same as that for other
      rehabilitative approaches to muscle, i.e.,to help maintain strength and mobility of these
      muscles during the post-operative treatment period when the muscles are not being used and
      are particularly vulnerable to scarring and atrophy.

      Two different paradigms of stimulation will be employed in order to compare and gain insight
      into the mechanisms involved in the remediation. This study also presents the opportunity to
      examine directly the changes in muscle produced by stimulation. Thus, a secondary research
      goal of the study that takes advantage of the opportunity presented by this intervention is
      to gain insight into the cellular changes that are thought to underlie the effects of
      radiation and subsequent electrical stimulation. By implanting these devices at the time of
      the neck surgeries, it is possible to target the nerves that supply specific muscles and thus
      ensure the excitation of specific muscles using current strengths much lower than those
      required with transcutaneous stimulation.
    

Intervention name(s): BION; BION; BION
Intervention type(s): Device; Device; Device
Intervention description(s): The second group will have a "High Stimulation" paradigm at a frequency that produces strong, fused contractions (20-30pps) for a total of 1h/d, also in two spaced sessions. Stimulation intensity will be adjusted to produce the strongest contractions that are tolerated.; The first group will have a stimulation paradigm employing low-frequency (1-5 pps), supramaximal "twitch" stimulation. The period of the stimulation will probably be short for the first sessions as the muscles gain strength and fatigue resistance, but will eventually be 60 minutes per day in two spaced sessions of about 30 minutes each.; A third group of experimental subjects will have a standardized program of voluntary swallowing exercises. Their BIONs will not be activated until they have worsening of dysphagia, and thus are considered to have failed conventional therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: swallowing function; neuromuscular stimulator