The Biber Protocol is a rehabilitation method for patients with dysphagia (difficulty swallowing) that utilizes neuromuscular electrical stimulation (NMES). It was created by Teresa Biber LoMonte, M.S., CCC-SLP in 1999.
Many treatment protocols, techniques and exercises have been developed for dysphagia. They include the Mendelsohn Maneuver, Shaker Exercises, Masako Exercises, Supraglottic Swallow, Super Supraglottic Swallow, Effortful Swallow, and Hyoid Lift Maneuver. These techniques and exercises have been used to increase strength and coordination of swallowing muscles/functions. NMES, or Neuromuscular Electrical Stimulation, has also been used for swallowing rehabilitation. Many protocols have been developed for using NMES to treat dysphagia including Effective Swallow Protocol/AmpCare, VitalStim, and The Biber Protocol®. The previously mentioned exercises and techniques can be performed while receiving NMES to maximize response and benefit from both.
Treatment with NMES involves the use of electrical stimulation that is generated by a device and delivered via electrodes placed on specific muscles to elicit a contraction. The pulses are painless and can activate weak or paralyzed muscles. The muscle activation is combined with specific tasks that can result in an improvement in swallowing, voicing and facial movement.
Over 177 articles have been published between 2000 and 2020 investigating the effectiveness of electrical stimulation for treatment of dysphagia including multiple systemic reviews and meta-analyses. Miller, et.al. in 2014 identified 180 studies that were reviewed for effects of NMES on facial paralysis, laryngeal paralysis, dysphonia, and dysphagia. Their conclusion was, “Evidence collected to date is encouraging; particularly for the treatment of certain forms of dysphagia and laryngeal paresis.”
There are many similarities in protocols that employ NMES to treat dysphagia. The Biber Protocol is based on 5 principles that define how it is used and how it is different from other approaches to NMES for dysphagia treatment. Some of these principles are used by other approaches in different combinations; however, only the Biber Protocol combines all 5: 1) modification and manipulation of electrical stimulation parameters, 2) singular submental electrode placement, 3) use of specific swallowing movement patterns simultaneously while the stimulation cycle is on, 4) home use to provide easier access to the treatment modality, and 5) implementation that is not device specific.
Modification and manipulation of electrical stimulation parameters
As mentioned above, this capability is a key factor in The Biber Protocol. VitalStim has recently adapted their protocol to accommodate function of a new device that allows for manipulation of these parameters. Other approaches do not incorporate this capability into their protocol.
Alon states that “Proper use of NMES dictates that you stimulate the right muscle, at the right time with the right parameters, to achieve the desired outcome”. This serves as the justification of allowing the clinician to modify and manipulate the parameters in order to achieve maximum physiological response.
Doucet, Lam and Griffin discussed the concept of manipulation of parameters in the Yale Journal of Biology and Medicine; “The delivery of electrical stimulation can be customized to reduce fatigue and optimize force output by adjusting the associated stimulation parameters. A full understanding of the settings that govern the stimulation is vital for the safety of the patient and the success of the intervention. Consideration should be given to the frequency, pulse width/duration, duty cycle, intensity/amplitude, ramp time, pulse pattern, program duration, program frequency, and muscle group activated.”
Singular submental electrode placement
This placement is defined as a single, bipolar placement of electrodes in the submental region. Use of this placement is based on the works of Bogaart, Palmer, et.al, Kim and Han, Park, et.al and Toyama et al.
This placement of the electrodes stimulates the suprahyoids. Stimulation of the suprahyoids elicits hyolaryngeal excursion (upward and forward movement). This movement is necessary for airway closure and upper esophageal sphincter (UES) opening during the swallow. Infrahyoids are not stimulated because they depresses the larynx for airway opening to take a breath after the swallow. The goal of NMES is to promote motor recovery by facilitating and improving the normal movement pattern and to avoid inhibiting it by providing stimulation that works against the patient’s efforts to swallow with the stimulation.
Use of swallowing movement patterns with stimulation
If stimulation is applied externally to the suprahyoid muscles, it evokes a movement pattern the same as what occurs when we swallow; that is, the hyolaryngeal complex moves upward and forward. This repetitive movement achieved through stimulation when combined with active swallowing as a part of rehabilitation results in cortical reorganization and neuromuscular re-education.
Stimulation of the suprahyoids using an NMES protocol with two electrodes in the submental region facilitates an observable and palpable hyolaryngeal excursion. The combination of purposeful skilled electrical stimulation combined with the active task of real swallowing results in true neuromuscular reeducation.
Like many protocols that incorporate swallowing/eating into the therapy protocol; this protocol also uses stimulation with functional swallowing activity. It also emphasizes the importance of timing the active swallow with the stimulation for maximum effect.
The Biber Protocol incorporates home use. This means that the patient is provided with a device and is taught how to apply electrodes and perform therapeutic swallows during the stimulation. The initial training and follow up is provided under the supervision of a treating clinician and with a physican prescription. The premise is that home use puts the treatment directly in the hands of a patient who can then receive many more sessions in the privacy of their own home and at their leisure with much less cost to the health care system.
Not device specific
This protocol was the basis for the development of many devices. Since it is based on the science of electrotherapy, any device can be used as long as the parameters can be customized during treatment. It can be used in any standard NMES device as long as there are adjustable parameters and the clinician has been properly educated via the Biber method. The Protocol is not device specific. The focus is on proper training and education in the principles of electrotherapy as opposed to sales of a particular device.
The Biber Protocol was developed by Teresa Biber LoMonte in 1999 while working at the Cleveland Clinic in Florida. She observed a patient receiving NMES for dense paralysis of the right arm and hypothesized that this treatment could be beneficial for individuals with dysphagia as well.
She developed the protocol in collaboration with the departments of otolaryngology and physical therapy and implemented it under their supervision for 2 years.
VitalStim filed a lawsuit against Teresa Biber LoMonte for patent infringement in 2002 which was settled out of court. Teresa was able to continue using her protocol and conduct research. In 2017 Teresa filed a lawsuit against Spectramed for unpaid wages, this was also settled out of court. Both cases were amicably resolved and are a matter of public record.
Some professionals continue to claim that NMES does not work and to argue against using it in dysphagia rehabilitation. It should be noted that the placement of electrodes and protocols used in the studies are not consistent with teachings of The Biber Protocol .
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