Clinical trial: Electrical Muscle Stimulation to Aid Swallowing in Dysphagia (NCT00001936)

Eligibility criteria:
-  INCLUSION CRITERIA FOR NORMAL VOLUNTEERS:

        The normal volunteers will be without cardiac, pulmonary, neurological, otolaryngological,
        psychiatric or speech, swallowing and hearing problems as determined by medical history and
        examination by a physician.

        EXCLUSION CRITERIA: SUBJECTS:

        For volunteers undergoing either intra-muscular stimulation or submental surface
        stiimulation:

        History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by
        medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to
        any study to exclude patients who might be at risk for endocarditis. Subjects will have an
        EKG as part of the screening for participation in the study.

        Pregnancy will exclude women from participation because the study involves radiation
        exposure.

        Subjects will also be excluded if they are taking psychiatric or neuroleptic medications
        which would interfere with the interpretation of the neurophysiological studies or are
        taking herbal medications that can affect coagulation.

        Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on
        medications for treatment of a psychiatric disorder will be excluded from study. Examples
        of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders,
        current major depression, or a history of schizophrenia or a bipolar disorder. However, a
        history of a previous episode of a minor reactive depression would not exclude a person
        from participation.

        Normal volunteers who are pregnant, or have any active medical or psychiatric conditions
        will not be included for submental surface stimulation, as these may be contraindications.

        For volunteers undergoing intra-muscular stimulation:

        Subjects will be excluded if they have a history of allergies to lidocaine.

        Subjects must be HIV negative. HIV testing for out of town participants may be done prior
        to traveling to the NIH. This is required because there is no potential benefit for normal
        volunteers from participation in the study. Because multiple needle insertions are required
        and the hooked wire electrodes remain in place for 1-2 hours increasing a risk of
        contamination, persons who are immuno-compromised would be put at undue risk with no
        opportunity for benefit.

        None of the normal volunteers will have a reduction in the range of vocal fold movement
        during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint
        abnormality or neoplasm.

        Caution will be exercised in patients with suspected or diagnosed heart problems or
        suspected or diagnosed with epilepsy at the discretion of the physician.

        INCLUSION CRITERIA FOR PATIENTS WITH CHRONIC PHARYNGEAL DYSPHAGIA:

        No peripheral laryngeal nerve injury that results in a lack of glottic closure for
        swallowing.

        No peripheral nerve injury to the muscles that will be stimulated for hyo-laryngeal
        elevation.

        No laryngeal trauma that results in a lack of glottic closure for swallowing.

        Intact cognition and hearing (30 dB HL in speech range); IQ no less than 85.

        Current dependence on alternate means of nutrition and hydration (PEG, PEJ, PPN/TPN);
        however, minimal PO is not cause for exclusion.

        Have stable vital signs before coming to the NIH for study. To determine if a patient has
        stable vital signs prior to admission and a physician has provided approval for
        participation, the following information will be required depending upon the location of
        the patient prior to admission. For patients in a nursing home setting, vital signs will be
        needed 3 days prior to admission and a written form signed by the physician releasing the
        patient. For patients not in a nursing home a physician's letter of referral written in the
        past year documenting that the patient is medically stable will be required and a telephone
        contact with the family or others involved in the patient's care that the patient is stable
        before coming to the NIH.

        At least 6 months post onset.

        A Mini-Mental State Examination (MMSE) score greater than or equal to 21.

        Evidence of pharyngeal dysphagia placing the patient at risk for aspiration.

        Participants may have other health problems such as diabetes mellitus, arteriosclerotic
        coronary vascular disease and a history of smoking. These will not be cause for automatic
        exclusion, but will be examined on an individual basis by the otolaryngologist in
        determining the potential risk and benefit to the individual participant.

        Patients will have restricted per oral intake. Prior history of tracheostomy or current
        tracheostomy is not a cause for exclusion.

        EXCLUSION CRITERIA:

        History of progressive neurodigestive disease, amyotrophic lateral sclerosis, etc.

        History of swallowing difficulties prior to most recent or previous CVA's.

        Dementia, obtundation, somnolence, and agitation.

        More than 90 years of age.

        A tracheostomy that fixes the laryngeal position interfering with the possibility of
        elevation.

        Moderate to severe oral phase swallowing dysfunction.

        Pharyngeal structural abnormalities on videofluoroscopy including mass and diverticulum.

        Esophageal motility not within normal range of function appropriate for the patient's age.

        Patient on a regular diet without difficulties.

        A MMSE score less than or equal to 20.

        Patients who are pregnant, have a cardiac demand pacemaker, dementia, exhibit non-stop
        vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be
        included for VitalStim, as these are contraindications for use of the device. Caution will
        be exercised in selection of patients with suspected or diagnosed heart problems or
        suspected or diagnosed with epilepsy at the discretion of the physician.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers

Subject must be at most 90 Years

Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Contradiction