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    Interventional procedure overview of pharyngeal electrical stimulation for neurogenic dysphagia

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    Description of the procedure

    Indications and current treatment

    Difficulty in swallowing (dysphagia) can be caused by neurological impairment affecting the muscles of the oropharynx. It can happen because of a stroke, traumatic brain injury (TBI), disorders of cerebral development, neurodegenerative diseases, major head and neck surgery (for example, to remove cancer) and intensive care treatment (intubation and tracheostomy). Dysphagia may lead to malnutrition, dehydration, aspiration pneumonia and death.

    Treatment options depend on the cause and severity of the dysphagia. Typical treatments include diet modification (inclusion of thicker fluids and foods) and swallowing therapy (to help relearn swallowing and strengthen muscles). In severe cases, nasogastric tubes or percutaneous endoscopic gastrostomy tubes may be used to provide nutritional support.

    What the procedure involves

    A catheter with 2 electrodes on the outside is passed through the nose into the pharynx. Guide marks on the catheter are used to ensure it is correctly positioned to deliver low-level pharyngeal electrical stimulation (PES). The catheter is connected to a portable base station, which stores patient information and adjusts the stimulation parameters. The exact stimulation level is calculated on an individual basis at the start of each treatment session. Treatment is given by a healthcare professional with appropriate training and typically consists of 10 minutes of stimulation each day for 3 consecutive days. People may experience a fizzing or tingling sensation in the throat during the procedure. The focused stimulation aims to increase brain activity in the swallow control centre and restore neurological control of the swallow function. The dual function catheter enables administration of enteral nutrition and fluids, if needed, as well as delivering electrical stimulation.

    Unmet need

    Dysphagia is associated with delayed decannulation, prolonged intensive care unit stays and increased dependence upon discharge. People who experience dysphagia report negative emotional and quality-of-life effects (such as from having to have a tracheostomy or feeding tube for a prolonged period of time). Treatment options are limited, particularly for people with post-stroke dysphagia, as these require active engagement from the individual.

    Figure 1 Flow chart of study selection

    Outcome measures

    Decannulation

    Readiness for decannulation is assessed with a standardised technique called the fibreoptic endoscopic evaluation of swallowing (FEES). Clinicians use this technique to check for pooling of saliva, spontaneous swallowing and sensation of the endoscope in the laryngeal vestibule. An algorithm is followed to determine whether a person is ready for their tracheostomy to be removed.

    Swallowing

    PAS

    The penetration-aspiration scale (PAS) is an 8-point scale that assesses the safety of swallowing. PAS score is assessed by endoscopic exam or videofluoroscopy and ranges from 1 (material does not enter the airway) to 8 (material enters the airway, passes below the vocal folds and no effort is made to eject). Higher scores indicate worse swallows and PAS of 3 or more is considered an abnormal swallow.

    DSRS

    The dysphagia severity rating scale (DSRS) provides an estimate of the severity of dysphagia post stroke, based on the amount of food and fluid modification people with the condition need as well as the level of supervision required. The subscales range from 0 to 4 (0 – normal/eating independently; 4 – no oral fluids/feeding). Higher scores indicate more severe dysphagia.

    FOIS

    The functional oral intake scale (FOIS) is a 7-point scale that assesses oral intake capacity. The scale ranges from 1 – no oral intake, to 7 – total oral intake with no restrictions. Lower scores indicate more severe dysphagia.

    MCID

    The minimal clinically important difference (MCID) is the minimum difference in a score that is considered valuable and changes patient management. The MCID for the DSRS was determined to be 1.0 point. It demonstrates a mean change in DSRS in patients having active treatment of greater than 1.0 point just a few days after completing treatment.

    Dependence/disability

    NIHSS

    The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses the level of neurological impairment in people with stroke. Subscales include the following: consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Each subscale is scored on a 3- to 5-point scale, with a total score of 42. Higher scores indicate worse impairment, with scores of more than 25 considered very severe and scores of 15 to 24 considered severe.

    mRS

    The modified Rankin Scale (mRS) is a 6-item scale that assesses dependence/disability. The scale ranges from 0 – no symptoms, to 6 – dead. Higher scores indicate more severe disability.

    Barthel Index

    The Barthel Index (BI) assesses activities of daily living across 10 items: feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling the bladder, controlling the bowel, moving from a wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs. Each item is scored from 0 (unable) to 2 (independent). The final score is multiplied by 5 to get a total score out of 100. Lower scores indicate higher levels of dependency.

    ALSFRS-R

    The amyotrophic lateral sclerosis (ALS) Functional Rating Scale Revised (ALSFRS-R) assesses the severity of ALS across several functional domains. Lower scores indicate higher severity.

    Quality of life

    EQ-5D

    The EuroQol 5-dimensions (EQ-5D) assesses health-related quality of life (QoL) across 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Higher scores indicate worse QoL. The second part of the EQ-5D includes the EQ visual analogue scale (EQ VAS). This is a vertical line that ranges from 0 (the worst health you can imagine) to 100 (the best health you can imagine). People mark the line to indicate how their health is that day. Higher scores indicate better health.

    SWAL-QOL

    The swallowing quality of life (SWAL-QOL) is a 44-item scale that assesses 10 aspects of QoL in people with dysphagia. Lower scores indicate worse QoL.