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Vital Stim Controversy
What is VitalStim?
VitalStim Therapy is a dysphagia treatment that uses Neuromuscular Electrical Stimulation to the swallowing muscles. Current is applied to the neck region, with the expectation that muscle function during swallowing will be enhanced. The use of VitalStim is FDA approved and must be used in conjunction with convetional swallow exercises. You must pass a certification program in order to perform VitalStim therapy. Certification includes an online course, written exam, 2-day conference where participants demonstrate the ability to use VitalStim effectively, and ability to correctly apply electrodes and operate the equiment appropriately.
Even if you do not ever use VitalStim, the conference reviews the anatomy and phsyiology of the swallow very effectively. There is a review of the cranial nerves used for swallowing such as the Trigeminal (CN V), Facial (CN VII), Glossopharyngeal (CN IX), Vagus (CN X) and Hypoglossal (CN XII).
Protocol for VitalStim
The protocol for VitalStim involves placing electrodes on the laryngeal and submental regions, depending on where the patient’s swallowing problems are. The intensity of the stimulation is increased until the patient reports feeling the “muscles grabbing.” Therapy is an hour long and patients are encouraged to perform swallow exercises while having the muscles stimulated. For example, patients may be asked to “swallow hard” with their saliva and then work up to ice chips, purees and solid foods.
VitalStim is not covered by insurance due to the paucity of evidence at this time.
Indications/Contraindications for VitalSim
According to the conference, candidates for VitalStim are thoses on a modified diet, at risk for aspiration, or patients demonstrating penetration or aspiration. Contraindications are those with an active cancerous tumor, severed/compromised nerve, Guillian Barre.
Although the conference teaches that VitalStim can be used on all individuals (except thet few contraindications), it seems that electrical stimulation should be considered only for persons with healthy sensory and motor nerves. Individuals who have injuries to the CNS may be candidates such as patients with a stroke, traumatic brain injury or excision of a brain tumor. After injury to cortical and/or subcortical pathways, cortical control may be lost or cortical inputs may be blocked, interfering with voluntary or automatic firing of the motor neurons in the brain stem for the craniofacial, laryngeal, and pharyngeal musculature during swallowing. Electrical stimulation bypasses that block by stimulating the axons from the motor neurons to fire the muscles, bypassing the central control abnormalities.
Conversely, if the client has intact sensory inputs to the brain stem, but the transmission of the sensory inputs from the brain stem to the thalamus and/or cortex is disrupted because of brain injury, then the client can no longer perceive the sensory information being relayed to the brain stem. In this case, electrical stimulation of the sensory nerves may augment the person’s sensation if there is some sensory relay to the thalamus and cortex so that the client can perceive the stimulus.
The presenters reported that VitalStim was beneficial on patients with ALS and Myasthenia Gravis. However, in electrical stimulation of muscles, the axons innervating muscle fibers—not the muscle fibers—are stimulated. Clients with motor neuron diseases such as ALS have motor neuron death resulting in axonal die back and loss of muscle fiber innervation, blocking the effects of electrical stimulation. Similarly, in persons with peripheral injury or neuropathies, such as spinal muscular atrophy, the axons die back and the muscle fibers are no longer innervated and can’t be accessed by electrical stimulation. Persons with myasthenia gravis have antibodies that block acetylcholine receptors on muscle fibers, preventing muscle fiber activation. Further, in sensory peripheral neuropathies, the sensory nerve endings are lost and can’t be stimulated. Therefore, TES is not an appropriate option to use with individuals with peripheral sensory and/or motor impairments.
Evidence for VitalStim:
There has been much debate regarding the benefits of Vital Stim. Whether or not VitalStim works is a tough questions since there is limited data. Empirical data regarding the effect of electrical stimulation specific to swallowing function primarily in adults are beginning to appear in peer-reviewed publications. Some of the results are conflicting, and there appears to be mixed evidence in regard to electrical stimulation’s rehabilitative effects on swallowing recovery. Evidence is needed for different types of diseases and disorders.
The limited research on this topic includes two reports of treatment outcomes before and after the introduction of TES (Blumenfeld, Hahn, Lepage, Leonard, & Belafsky, 2006; Kiger, Brown, & Watkins, 2006). One report was a retrospective unblinded chart review comparing changes in swallow severity, and found a greater benefit in a TES group compared with the traditional dysphagia treatment (TDT) group (Blumenfeld et al., 2006). The other report compared unblinded ratings of videofluoroscopic and fiberoptic endoscopic evaluations of oral and pharyngeal swallowing (FEES) before and after either TES or TDT treatment. The TDT group experienced greater improvements in both the oral and pharyngeal phases than did the TES group (Kiger et al., 2006). As changes in dietary consistency advancement did not differ between the two groups, the authors concluded that there was no difference in outcome between the two groups (Kiger et al., 2006). Thus, these two investigations yielded inconsistent results, but because neither study included random assignment of participants to different treatment conditions, their validity is questionable.
A more recent study (Permsirivanich W, Tipchatyotin S, Wongchai M, et al., 2009), also compared the use of NMES (VitalStim) with traditional treatment techniques. They randomized 23 subacute stroke patients with severe dysphagia into a rehabilitation group receiving traditional interventions or an NMES group receiving NMES with swallowing exercise. They found that the NMES group made significantly greater gains in their swallow function.
A meta-analysis combining some of the TES studies found a modest effect size of 0.6 (Carnaby-Mann & Crary, 2007); however, the effect sizes for TES with TDT versus TDT alone is unknown. Two uncontrolled reports on a series of patients, one retrospective (Shaw et al., 2007) and the other prospective (Leelamanit, Limsakul, & Geater, 2002), provide some information regarding severity of dysphagia and response to TES. The prospective study found that the more severely involved participants with post-stroke dysphagia did not improve to the same degree as the participants whose swallowing problem was idiopathic or due to aging. The retrospective case series found a relationship between participants’ initial severity and subsequent improvement with TES. Mildly to moderately impaired participants showed some improvement, while participants with the most severe dysphaga did not improve with TES treatment (Shaw et al., 2007). Without a control group, it cannot be determined whether or not recovery in the mildly to moderately impaired persons was due to TES, dysphagia therapy, or spontaneous recovery.
However, the results of these two case series are in agreement with the physiological findings on the effects of TES (Humbert et al., 2006; Ludlow et al., 2007). Ludlow and colleagues (2007) concluded that participants with severe dysphagia who are unable to overcome the TES induced hyo-laryngeal descent during swallowing may not benefit from TES. That is, the risk of aspiration or penetration may be increased because the application of TES can reduce hyo-laryngeal elevation even in healthy persons with normal swallowing (Humbert et al., 2006). Therefore, it is recommended that clinicians evaluate whether or not a patient has increased risk of aspiration or penetration during swallowing when the device is turned on at an effective level during videofluoroscopy before considering using TES in therapy.
The result of a systematic review of the literature by Clark in 2009: “Promising results are reported in the reviewed literature on the use of surface NMES as a motor facilitation tool (VitalStim). The useof NMES as a sensory facilitation tool is also reported as a promising modality. Studies on both these application methods generally have methodological limitations, making it difficult to estimate effect size.”
Surface NMES to the neck has been most extensively studied with promising findings, yet high-quality controlled trials are needed to provide evidence of efficacy. Even if we are certified in VitalStim, we should continue to use the available research to evaluate outcomes. As speech-language pathologists, we can personally acquire new clinical data to the existing research for specific populations.
References:
Blumenfeld, L., Hahn, Y., Lepage, A., Leonard, R., & Belafsky, P. C. (2006). Transcutaneous electrical stimulation versus traditional dysphagia therapy: a nonconcurrent cohort study. Otolaryngology—Head and Neck Surgery, 135(5), 754-757.
Carnaby-Mann, G. D., & Crary, M. A. (2007). Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Archives of Otolaryngology—Head & Neck Surgery, 133(6), 564-571.
Humbert, I. A., Poletto, C. J., Saxon, K. G., Kearney, P. R., Crujido, L., Wright-Harp, W., et al. (2006). The effect of surface electrical stimulation on hyo-laryngeal movement in normal individuals at rest and during swallowing. Journal of Applied Physiology, 101, 1657-1663.
Kiger, M., Brown, C. S., & Watkins, L. (2006). Dysphagia management: an analysis of patient outcomes using VitalStim therapy compared to traditional swallow therapy. Dysphagia, 21(4), 243-253.
Leelamanit, V., Limsakul, C., & Geater, A. (2002). Synchronized electrical stimulation in treating pharyngeal dysphagia. Laryngoscope, 112(12), 2204-2210.
Ludlow, C. L., Humbert, I., Saxon, K., Poletto, C., Sonies, B., & rujido, L. (2007). Effects of surface electrical stimulation both at rest and during swallowing in chronic pharyngeal dysphagia. Dysphagia, 22, 1-10.
Permsirivanich W, Tipchatyotin S, Wongchai M, et al (2009). Comparing the effects of rehabilitation swallowing therapy vs. neuromuscular electrical stimulation therapy among stroke patients with persistent pharyngeal dysphagia: a randomized controlledstudy. J Med Assoc Thai. 92(2):259-265.
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