Amyotrophic Lateral Sclerosis (ALS), Dysphagia, Dystussia
Conditions
Brief summary
Prospective, single-arm pilot study evaluating transcutaneous electrical nerve stimulation of the superior laryngeal nerve (TENS-SLN) in individuals with ALS. Up to 5 participants with confirmed ALS and bulbar involvement will be enrolled. Primary outcomes: swallowing frequency and perceived urge to swallow. Participants complete a baseline visit, followed by two supervised treatment sessions within one week, and a final post-treatment evaluation. Optional visits (up to 2) may be used to individualize stimulation parameters prior to treatment. Swallowing function will be assessed using physiological monitoring, fiberoptic endoscopy, and videofluoroscopic swallow study (VFSS). TENS-SLN is a non-invasive neuromodulation approach targeting sensory pathways to facilitate swallowing without inducing muscle contraction. This pilot study is designed to assess feasibility, safety, and preliminary effect sizes to inform future randomized trials, and is not powered to determine efficacy.
Detailed description
This prospective, single-arm interventional pilot study will evaluate the acute effects of transcutaneous electrical nerve stimulation of the superior laryngeal nerve (TENS-SLN) on swallowing function in individuals with amyotrophic lateral sclerosis (ALS). Up to five participants with confirmed ALS and bulbar involvement will be enrolled. The primary outcomes are swallowing frequency and perceived urge to swallow. Participants will complete a baseline assessment followed by two supervised TENS-SLN treatment sessions conducted within a one-week period. Up to two additional visits may be performed prior to treatment to optimize individualized stimulation parameters. Treatment sessions may take place in the clinic or the participant's home under clinician supervision. A final in-clinic evaluation will be completed at the end of the study period. Swallowing function will be assessed using physiological monitoring, fiberoptic endoscopy, and videofluoroscopic swallow study (VFSS) at baseline and post-intervention. TENS-SLN is a non-invasive neuromodulation approach that delivers low-intensity electrical stimulation via surface electrodes placed over the anatomically accessible superior laryngeal nerve in the anterior neck. The intervention is designed to enhance sensory input to swallowing-related neural circuits and facilitate swallow initiation without directly eliciting muscle contraction. This pilot study is not powered to determine efficacy but is intended to assess feasibility, safety, and preliminary effect sizes to inform the design of future randomized controlled trials. All study procedures are performed for research purposes and are not part of standard clinical care.
Interventions
OTHERTranscutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow
Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in ALS
Sponsors
Nova Southeastern University
Curators of the University of Missouri
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm, within-subject (pre-post) design. All participants receive the investigational intervention (TENS-SLN), and outcomes are compared within subjects across baseline and post-intervention assessments. Non-invasive electrical stimulation delivered via a commercially available, FDA-approved TENS unit using surface electrodes positioned over the s Participants receive transcutaneous electrical nerve stimulation of the superior laryngeal nerve (TENS-SLN) during two supervised treatment sessions conducted within a 7-day period. Up to two additional visits may be used prior to treatment to individualize stimulation parameters. Stimulation is delivered using surface electrodes placed over the superior laryngeal nerve in the anterior neck and is titrated to evoke swallowing at a comfortable sensory level. Each treatment session includes up to 30 minutes of active stimulation (up to 15 minutes per side), with continuous physiological monitoring to assess swallowing frequency and safety.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of ALS (El-Escorial Criteria) * ALS FRS Bulbar Subscore of ≤ 10 and ≥ 3. * Functional Oral Intake scale score ≥ 2
Exclusion criteria
* A diagnosis of significant cognitive impairment or frontotemporal dementia per the treating neurologist or neuropsychologist, * Current nasogastric tube placement * Current head and neck carcinoma * Pacemaker or implanted defibrillator or history of diagnosed arrhythmia, bradycardia, or repeated attacks of hypotension, * Implanted vagal nerve stimulator * Current pregnancy * History of epilepsy * Infected, broken or inflamed skin on the neck, or impaired sensation at the site of sEMG or TENS placement * Living greater than 50 miles from the NSU clinic round trip * Any clinical reason that this stimulation may not be a suitable treatment according to the principal investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing Frequency | From enrollment to the end of the 7-day follow-up period | The count of swallows per unit time with predefined epochs |
| Urge-to-swallow | Measured from enrollment to the end of the 7 day follow up period | patient reported urge to swallow during rest and stimulation periods on a modified Borg scale, 0 (very easy) to 10 (very difficult to elicit a swallow) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight gain/loss | At Day 1 and at Day 7 | The total body weight (lbs) |
| Maximum Expiratory Pressure | From enrollment to the end of the 7-day follow up period | Maximum expiratory pressure achieved during forceful exhalation |
| Lingual pressure assessment | At baseline (Day 1) pre-procedural, on Day 1 post-procedure, and on Day 7 | Maximum lingual pressure and saliva swallowing pressures will be obtained using the IOPI oral performance in 3 instances. |
| Peak cough flow | One at enrollment and one at the end of the 7- day folow-up period | Maximum expiratory flow achieved during the expulsive phase of the cough (PCF, L/min) |
| Videofluoroscopic Swallowing Evaluation | At baseline and at the end of the 7-day follow-up period | Yale residue Scale to assess post-swallow residue in the pharynx following swallow trials. (5 point ordinal scale; graded 1 being none -5 being severe) Dynamic Imaging Grade of Swallowing Toxicity for FEES safety, efficiency, and total scores. (each subscore is graded on scale from 0-4; 0 being no impairment, being profound/life-threatening impairment) |
| Fiberoptic Endoscopic Evaluation of Swallowing (FEES) | At baseline and again at the end of the 7 day follow up period | New Zealand Secretion Scale to assess oropharyngeal secretions and clearance response on a 7-point ordinal scale. (Maximum 7- Minimum 0) Laryngeal Kinematics: presence of vocal fold adduction and abduction |
| Body Weight (BMI) | Day 1 - Day 7 | Total BMI measured at Baseline (day 1) and at the end of th study (Day 7) |
Contacts
CONTACTRacquel Garcia, SLPD, CCC-SLP
PRINCIPAL_INVESTIGATORLauren Tabor Gray, Ph.D CCC-SLP
Nova Southeastern University
Outcome results
None listed