Evidence & Clinical Data

Evidence & Clinical Data

Embraced by therapists, supported by data
Neuromuscular electrical stimulation (NMES) used as an adjunct modality in the treatment of dysphagia has gained increasing adoption by medical professionals. The evidence base has grown significantly in recent years.

Safety

The use of NMES in the treatment of dysphagia has been consistently demonstrated to be safe.In tracking for the occurrence of adverse events during clinical studies, none were reported across all patient ages and diagnoses. During the initial FDA clearance study (1) and in all known studies since, there have been:

• no reports of laryngospasm
• no reports of bradycardia
• no reports of electromagnetic interference with cardiac pacemakers
• no changes in pulse oxymetry readings, heart rate, or blood pressure
• no adverse events in the pediatric population (2)

Efficacy

There are currently numerous positive studies and a meta-analysis in print that corroborate the positive findings reported in the field. The findings include the following:

• The use of electrical stimulation seems to contribute significantly to the improvement in swallow function (3)
• NMES in conjunction with swallowing exercise seems to be more effective than traditional treatment techniques alone (4)
• Mild (limited oral intake) to moderate (PEG fed with minimal oral intake) dysphagia patients benefit the most with over 80% discontinuing PEG (5)
• Use of NMES tends to decrease inpatient length of stay as a result of improved swallow function (4)

User and patient satisfaction

Besides the growing empirical evidence base, the adoption of VitalStim Therapy is increasing as a result of widespread reports of good patient outcomes and good patient satisfaction. Crary and colleagues confirmed these outcomes in an independent user survey of 2000 Speech Pathologists (6).

• Freed ML. Clinical trial data in support of VitalStim 510(k) clearance application with FDA. 2001.
• Christiaanse M, Glynn J, and Bradshaw J. Experience with transcutaneous electrical stimulation: A new treatment option for the management of pediatric dysphagia. In: NCSHA. Charleston: 2003.
• Carnaby-Mann GD, and Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg 133: 564-571, 2007.
• Blumenfeld L, Hahn Y, Lepage A, Leonard R, and Belafsky PC Transcutaneous electrical stimulation versus traditional dysphagia therapy: nonconcurrent cohort study. Otolaryngol Head Neck Surg 135: 754-757, 2006.
• Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, and Dowdy E. Transcutaneous neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality? Ann Otol Rhinol Laryngol 116: 36-44, 2007.
• Crary MA, Carnaby-Mann GD, and Faunce A. Electrical stimulation therapy for dysphagia: descriptive results of two surveys. Dysphagia 22: 165-173, 2007.

Research Articles

In addition to having many successful outcomes with dysphagia patients across the country, VitalStim Therapy has been the subject of a number of clinical trials and studies since its introduction. VitalStim is not stand-alone therapy, as some of the research shows: dysphagia patients see the strongest improvement when VitalStim is used as an adjunct to standard dysphagia therapy techniques. However, the body of research supporting VitalStim is stronger, in terms of number of studies and favorable outcomes, than that for standard dysphagia therapies.
Use the links below and to the left to view the most recent research abstracts on VitalStim, to request complete copies of published studies, and to learn more about FDA clearance for VitalStim Therapy.
( The rest of the articles in this section, pls download it from the vitalstim .com – health professionals – research and articles as it contains the research paper.

VitalStim® FDA Documentation

The only NMES-based therapy to receive this clearance from the FDA.

VitalStim® Therapy was granted clearance by the Food & Drug Administration in December 2002. VitalStim is the only NMES-based therapy to receive this clearance from the FDA. Clearance covers the therapy modality and equipment used in the delivery of VitalStim® Therapy for the treatment of dysphagia. Use of other methods, equipment or accessories is not considered VitalStim® Therapy.

FDA clearance came after submission and thorough review of an extensive clinical trial comparing the relative effectiveness of VitalStim to thermal-tactile stimulation in patients with dysphagia. 892 patients were studied from 1993 through 1998; three-year follow up data for 300 of these patients was submitted to the FDA.Key findings of the study:

• The majority of the patients improved their swallowing function with VitalStim
• The majority of mild to moderate level dysphagia patients improved their diets to normal levels with VitalStim
• with VitalStim, the majority of PEG tube-dependent patients advanced past the point of taking all their nourishment via a feeding tube

strong>These findings compare to the results seen with patients receiving only thermal-tactile stimulation:

• 32.7% of patients’ swallowing score improved
• 38.9% of feeding tube-dependent patients regained function past the point of taking all nourishment via a feeding tube
• No patients with severe dysphagia recovered full, normal swallow function
• Results shown here are based on FDA submission data. Individual results may vary

Training

Register To Become VitalStim® Therapy Certified
The addition of VitalStim® Therapy to your dysphagia treatment program is an excellent way to ensure your patients receive the best and most advanced treatment.
A dysphagia Speech and Language Therapist must become VitalStim® Certified in order to use VitalStim® Therapy. This certification is awarded by Career Improvement and Advancement Opportunities (CIAO), USA; it certifies that the learner has successfully completed the VitalStim ® Certification educational process. There are two types of training.

How does a clinician get certified to perform VitalStim Therapy?

A good knowledge base of dysphagia, head and neck physiology, and VitalStim protocol is key to obtaining successful treatment outcomes with VitalStim Therapy. Because the education component is such an important factor, flexible learning opportunities are available through two options.

Option:1

A two day training course organized by TI Anode (UK). 7-8 October, Management and Treatment of swallowing disorders. Non invasive approach using a specialized form of neuromuscular electrical stimulus (nmes) designed to treat dysphagia through muscle re-education to improve swallow function.

1.MBS : The Clear Picture

Online interactive course via internet – Normal swallow, assessment of swallow, manipulate colorful 3-D anatomical structures and communicate with personal instructor – 12 hours CPD

2.VitalStim® Therapy Certification Course 2 days

Principals, theory, concepts of NMES, traditional dysphagia techniques, VitalStim® Therapy protocol. Extensive review, practice, hands on equipment training by US Specialists. Please download the above course contents.

Option:2

Certification course or through electronic courses on CD concluding with an on-line certification exam.
The VitalStim Education Suite and Passport to Certification is a multiple CD set designed to give the physician or SLP all required information to provide VitalStim Therapy to their patients.

1.Primal Pictures Head and Neck

3D interactive anatomical resource of the head and neck.

2.Anatomy and Physiology of the Head and Neck

Focuses specifically on the swallowing mechanism.

3.MBS: The Clear Picture

Concentration on basic observational skills for the modified barium swallow study (MBSS).

4.About Dysphagia

Compilation of documents that provide a greater understanding of this disorder.

5.italStim Therapy

Background information on the use of neuromuscular electrical stimulation and video presentation of electrode placement and device usage.

Once proficient with the information found on the CD’s, the clinician is ready to be certified. VitalStim certification is obtained via successful completion of the online examination. Certification allows the therapists to provide safe and effective treatments to their dysphagic patients.