VitalStim® Therapy

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An exciting new therapy, proven and painless. Introducing VitalStim® Therapy, the first proven treatment for dysphagia. It's the only dysphagia therapy backed by compelling clinical data and cleared by the Food and Drug Administration (FDA).

VitalStim Therapy uses small electrical currents to stimulate the muscles responsible for swallowing. At the same time, trained specialists help patients "re-educate" their muscles through rehabilitation therapy.

A small, carefully calibrated current is delivered by specially designed electrodes. The current stimulates motor nerves in the throat causing the muscles responsible for swallowing to contract. The quality of the swallowing function improves and with repeated therapy, muscles may be re-educated.

VitalStim® Therapy is not a traditional NMES treatment. And, therefore, received FDA clearance for use on the swallowing muscles. It uses only small amounts of electrical current.

VitalStim Therapy must be prescribed by a physician. It can only be administered under the direction of certified health care professionals with at least three years' experience treating dysphagia.

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Advantages

  • Cleared to market by the FDA in December 2002, VitalStim Therapy is a non-invasive external electrical stimulation therapy that re-educates the throat muscles needed for swallowing.
  • Offers dual channel and is used with electrodes specifically designed for application to the muscles of the throat to promote swallowing.
  • VitalStim Therapy can only be administered by those who have passed the certification process.
  • Device is portable.


Specifications

  • Output Configuration: Dual Channel, electrically isolated with miniature safety connectors.

  • Output Waveforms: AC Mode: Rectangular symmetrical biphasic with zero net DC.

  • Patient Voltage: 100 Volts Maximum, No Load

  • Intensity Control: Dual intensity potentiometers: 0-25 mA peak current output, adjustable current. Constant current regulation from 0 to 4000 ohms load minimum.

  • Pulse Rate: Fixed, 80 Hz

  • Pulse Duration: Fixed, 300 μSec

  • Pulse Charge: Maximum of 8 μCoulombs under normal operation

  • Output Protection: Under 15 μCoulombs charge per pulse with any single component failure.

  • Time Base: Crystal controlled oscillator operating at 3.58 MHz Power Source Two AA (1.5 volt) Alkaline Batteries. ANSI Type NEDA1604A. Nickel-Metal-Hydride or Nickel- Cadmium rechargable batteries.

  • Internally Powered: Type BF

  • Battery Life: 24 hrs until Low Battery indicator blinks

  • Circuit Design: Microcomputer with no internal adjustments

  • Calibration: No Calibration Required or Needed

Q: What is Dysphagia?
A: Dysphagia is defined as any difficulty in swallowing. Symptoms of dysphagia can include coughing while swallowing or after swallowing, choking on food or liquid, the sensation of food getting stuck in the throat, pain during swallowing, shortness of breath during feeding and onset of pneumonia.
Q: What is VitalStim Therapy?
A: A therapeutic intervention for the management of dysphagia. VitalStim Therapy uses small electrical currents to stimulate the muscles responsible for swallowing. At the same time, trained specialists help patients "re-educate" their muscles through rehabilitation therapy.
Q: How does it work?
A: A small, carefully calibrated current is delivered to the motor nerves of the patient's throat through specially designed electrodes causing the muscles responsible for swallowing to contract. At the same time, a dysphagia specialist guides the patient through active swallowing therapy to re-educate normal swallow function.
Q: How is VitalStim different from conventional swallowing therapy?
A: Conventional therapy for dysphagia typically employs both compensatory strategy techniques (diet changes, head positioning or modifying bolus size) and specific techniques aimed at improving the coordination and strength of the swallowing muscles (thermal stimulation, biofeedback, mendelssohn maneuver or supraglottic swallow). VitalStim Therapy is the use of electrical stimulation for activation of muscles. Research shows that the combination of electrical stimulation and traditional treatment techniques is very effective at restoring swallowing function.
Q: How long is a treatment session?
A: Treatment sessions usually last an hour.
Q: How many sessions of VitalStim treatment before my swallowing improves?
A: This depends a lot on the underlying medical problem causing the dysphagia. In many patients, improvement in the swallowing function starts almost immediately. Patients often see good results in 6 to 20 treatment sessions. Initial sessions are usually delivered on a daily basis but later sessions are often given every other day.
Q: Does this work with all forms of dysphagia?
A: One of the most common forms of dysphagia is oropharyngeal dysphagia which affects stroke survivors, patients with progressive neuromuscular disorders, head and neck cancer survivors and the elderly.
Q: Does VitalStim Treatment hurt?
A: No. VitalStim is a non-invasive, painless treatment.
Q: Is VitalStim Therapy safe?
A: Yes. VitalStim Therapy is the only technology cleared by the FDA for restoring the swallowing function to patients with oropharyngeal dysphagia
Q: Who can receive VitalStim Therapy?
A: VitalStim Therapy is effective for both sexes and all ages.
Q: Can this be used on children?
A: Yes. VitalStim Therapy can be considered for patients of all ages in which oropharyngeal dysphagia is a problem. Clinical studies showed VitalStim Therapy as effective for patients 1-4 years old as for older patients. VitalStim Therapy was also found to be effective on infants less than 1 year old.
Q: Who cannot receive VitalStim Therapy?
A: Most dysphagia patients can be treated with VitalStim Therapy. Some caution must be observed for severely demented patients who exhibit non-stop verbalization, patients with significant reflux due to use of a feeding tube and patients with dysphagia due to drug toxicity.
Q: What about patients with pacemakers?
A: A. Caution should be used with patients who have cardiac demand pacemakers.
Q: What are the side effects of VitalStim Treatment
A: The only problematic issue found during the study was the occasional occurrence of skin irritation as a result of the adhesive used to secure the stimulation electrode to the anterior portion of the neck.
Q: How effective is VitalStim Therapy?
A: 98.4% of patients improved their swallow function score; 97.5% of patients with severe dysphagia regained swallow function past the point of PEG tube dependency; 38.3% of patients with severe dysphagia regained full normal swallow function; At three-year follow up, over 76% had retained swallow function
Q: What medical specialists provide VitalStim Therapy?
A: Medical specialists that commonly specialize in swallowing disorders include Speech-Language Pathologists and Occupational Therapists. A certification in VitaStim Therapy is required prior to treatment given.
Q: Does insurance cover VitalStim Therapy?
A: Medicare recognizes and provides reimbursement for the treatment of swallowing dysfunction provided the treatment is medically necessary and delivered by a qualified professional.

Vitalstim FDA Pre-Market Approval Study . . ;. Read Abstract

Shaw G, Sechtem P, Searl J, et al. Transcutaneous Neuromuscular Electrical Stimulation (VitalStim) Curative Therapy for Severe Dysphagia: Myth or Reality? Annals of Otology, Rhinology & Laryngology 2007;116(1):36-44.. . ;. Read Abstract

Effect of Electric Stimulation on Swallow Function in Patient with Polymyositis: A Case Report. D’Souza K, Krieger R, Kobe C, Arch Phys Med Rehab. 2006;87(11):e14. . ;. Read Abstract