Inconsistent Messages from the VS Cert Course

VitalStim Therapy Key Points

The standardized training program in place for VitalStim Therapy teaches several key points about the treatment approach that are essential to success. This document clarifies and reinforces some of these.

Duration of a treatment session

The VitalStim protocol use 60 minutes as a preferred duration of a treatment session. This recommendation is based on data submitted to the FDA. The results described in this data set(Freed 2001) demonstrate safety and efficacy.However, this data nor data published in other works since then provides any specific guidance regarding the best number of minutes of treatment per session for different patient conditions. Therapists should use their best clinical judgment in determining treatment duration. The following guidelines may help decision making.

General guidelines:

1. In neurological patients where cortical reorganization is the key neurophysiological mechanism responsible for recovery of the swallow, more frequent and longer (up to 60 minutes) treatment sessions may be more beneficial.
2. In disease states where fatigue is a prominent symptom, shorter treatment sessions will be more common.

Therapeutic intensity

Some therapists mistakenly feel that moreisbetter when it comes to current intensity, thinking that if a patient is receiving more current the benefit will be greater. This mindset may lead the therapist to increase intensity levels at each subsequent treatment session.

The target intensity taught in the VitalStim certification course is a “submaximal motor” level stimulation, defined as the level where a contraction is elicited in the target musculature but physiological functional movement is still possible.

“Submaximal motor” stimulation is not an objective term; it may mean different things to different therapists and may produce different levels of facilitation in different patients. When 2 or more of the following signs are evident, a submaximal motor level stimulation has been achieved:

• Change in audible quality of swallow
• Patient report of a “holding”, “”squeezing” sensation
• Spontaneous swallows are triggered
• Swallowing is improved (less overt signs of penetration/aspiration)
• Body language changes with patient sitting up straighter

General guidelines:

1. Increase the intensity until 2 or more signs of an evoked contraction are identified.
2. Let functional performance of the patient guide whether intensity should be adjusted up or down.

Should a patient receive an MBS before starting VitalStim?

An MBSS/VFSS is not a prerequisite to receiving VitalStim Therapy. The therapist should use whatever tools are available to formulate a sound treatment hypothesis before initiating treatment. This treatment hypothesis verbalizes the impairment that is causing the patient’s dysphagic signs and symptoms and guides treatment. The evaluation process will also dictate which muscle groups need to be targeted.

General guidelines:

1. Before starting treatment, perform a thorough evaluation using whatever evaluation tools and techniques that are available and required. Don’t start treating until you can answer, with a fair amount of confidence, “What is going on that is causing this swallowing problem?”
2. Use objective data and clinical know-how to guide decision making.

VitalStim Therapy is evidence based therapy

More research activity has occurred on the subject of the use of neuromuscular electrical stimulation than on any other modality in the treatment of dysphagia. Research shows the modality to be safe and effective. (Carnaby-Mann and Crary 2007)

VitalStim and implanted electronic devices

Therapists are understandably concerned about patient safety. This concern is possibly amplified by the fact that the FDA issues a warning (potential for serious harm) against using powered muscle stimulators in patients with such devices. In the case of VitalStim, the FDA did not issue this warning. Instead, the presence of implanted electronics is listed as a precaution. Refer to the document, Safety Issues regarding the use of VitalStim Therapy for more information.

General guidelines:

1. Implanted electronics are listed as a precaution. It is OK to use VitalStim.
2. Therapists should know which device is implanted and should be alert to signs of electromagnetic interference (EMI).
3. There is no requirement to receive special clearance from a physician (e.g., cardiologist) before initiating VitalStim in these patients.

VitalStim and cancer

One should avoid causing current to flow through a site of active neoplasm (abnormal tissue that grows by cellular proliferation more rapidly than normal).The FDA therefore lists the use of NMES as contraindicated – the risk of harm is greater than the potential benefit – when applied over neoplastic tissue. Current flow may lead to increased blood flow and increased metabolic activity.

The key variable is the location of the neoplastic tissue: do not cause the current to flow through the lesion. Lesions outside of the field of current flow are of no concern.

Another important variable to consider is whether the lesion is active or not. It may have been radiated, excised or otherwise be in remission. Is it OK for a therapist to assume that a lesion is not active and commence VitalStim? The rule of thumb in this instance is to consult the treating physician.

The dysphagia therapist is part of a team treating the patient and should always consult with the other team members.

General guidelines:

1. Do not apply VitalStim when it is reasonable to expect that the current will flow through a site of active neoplasm.
2. If the lesion is located outside of the field of current flow, the use of VitalStim is not contraindicated.
3. When in doubt, consult the treating physician.

Can one treat anything other than dysphagia with VitalStim?

The use of VitalStim has been cleared by the FDA for the treatment of dysphagia only. Data is now emerging to suggest positive treatment effects in other dysfunctions as well(Lagorio et al. 2006)but no FDA clearance has yet been received for any indication other than dysphagia.

Therapist practice is not regulated by the FDA but by state and national regulations. The therapist should base decisions regarding the choice of a modality on clinical analysis of the patient condition and potential benefit of the modality.

Can a motor response be obtained below 10mA?

Motor response when applying NMES is determined by the extent to which current reaches the motor neurons located under the skin. Current flowsdeeper in some patients than in others, depending on the amount of resistance encountered by the current.A suitable submaximal motor response may therefore be reached well below 10 mA.

General guidelines:

1. Turn up the intensity to whatever level gives you the desired response. Do NOT focus on the number.
2. In most patients a motor level stimulation is not reached below 2.5 mA.

VitalStim and cognitive impairment

A foundational concept in the therapeutic use of NMES is that best functional results are obtained when using the modality during volitional and functional exercise. In this treatment paradigm, the use of NMES serves as a facilitator of functional movement and enhances the impact of exercise. The use of NMES to improve swallowing function should therefore be applied while at the same time engaging the patient in active swallowing activities, either volitional or reflexive. Thus, patients with cognitive impairments may or may not be appropriate to receive VitalStim.

General guidelines:

1. Determine appropriateness of use of VitalStim on the potential to engage the patient in functional swallowing, either voluntary or reflexive.

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References

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.

Freed ML. Clinical trial data in support of VitalStim 510(k) clearance application with FDA. 2001.

Lagorio L, Carnaby-Mann G, and Crary M. The effects of NMES on selected voice parameters: A case study. In: ASHA. Miami, FL: 2006.

VitalStim TherapyPage 1 of 4

August 20, 2010