Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in Patients Living With ALS
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Racquel Garcia, SLPD, CCC-SLP
- Telefoonnummer: (954) 262-1271
- E-mail: rw602@nova.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Interventionele groep
|
Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in ALS
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Swallowing Frequency
Tijdsspanne: From enrollment to the end of the 7-day follow-up period
|
The count of swallows per unit time with predefined epochs
|
From enrollment to the end of the 7-day follow-up period
|
|
Urge-to-swallow
Tijdsspanne: 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)
|
Measured from enrollment to the end of the 7 day follow up period
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body weight gain/loss
Tijdsspanne: At Day 1 and at Day 7
|
The total body weight (lbs)
|
At Day 1 and at Day 7
|
|
Maximum Expiratory Pressure
Tijdsspanne: From enrollment to the end of the 7-day follow up period
|
Maximum expiratory pressure achieved during forceful exhalation
|
From enrollment to the end of the 7-day follow up period
|
|
Lingual pressure assessment
Tijdsspanne: 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.
|
At baseline (Day 1) pre-procedural, on Day 1 post-procedure, and on Day 7
|
|
Peak cough flow
Tijdsspanne: 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)
|
One at enrollment and one at the end of the 7- day folow-up period
|
|
Videofluoroscopic Swallowing Evaluation
Tijdsspanne: 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)
|
At baseline and at the end of the 7-day follow-up period
|
|
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Tijdsspanne: 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
|
At baseline and again at the end of the 7 day follow up period
|
|
Body Weight (BMI)
Tijdsspanne: Day 1 - Day 7
|
Total BMI measured at Baseline (day 1) and at the end of th study (Day 7)
|
Day 1 - Day 7
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Lauren Tabor Gray, Ph.D CCC-SLP, Nova Southeastern University
Publicaties en nuttige links
Algemene publicaties
- Plowman EK, Watts SA, Tabor L, Robison R, Gaziano J, Domer AS, Richter J, Vu T, Gooch C. Impact of expiratory strength training in amyotrophic lateral sclerosis. Muscle Nerve. 2016 Jun;54(1):48-53. doi: 10.1002/mus.24990. Epub 2016 Mar 3.
- Tabor LC, Rosado KM, Robison R, Hegland K, Humbert IA, Plowman EK. Respiratory training in an individual with amyotrophic lateral sclerosis. Ann Clin Transl Neurol. 2016 Sep 1;3(10):819-823. doi: 10.1002/acn3.342. eCollection 2016 Oct.
- Robison R, Tabor-Gray LC, Wymer JP, Plowman EK. Combined respiratory training in an individual with C9orf72 amyotrophic lateral sclerosis. Ann Clin Transl Neurol. 2018 Aug 21;5(9):1134-1138. doi: 10.1002/acn3.623. eCollection 2018 Sep.
- Plowman EK, Tabor-Gray L, Rosado KM, Vasilopoulos T, Robison R, Chapin JL, Gaziano J, Vu T, Gooch C. Impact of expiratory strength training in amyotrophic lateral sclerosis: Results of a randomized, sham-controlled trial. Muscle Nerve. 2019 Jan;59(1):40-46. doi: 10.1002/mus.26292. Epub 2018 Nov 29.
- Tabor Gray, L., Locatelli, E., Vasilopoulos T., Wymer, J., Plowman, EK. (2022). Impact of Nuedexta on Bulbar Function and Physiology. Muscle and Nerve, 66(S2), S1-S63. https://doi.org/https://doi.org/10.1002/mus.27729
- Plowman EK, Gray LT, Chapin J, Anderson A, Vasilopoulos T, Gooch C, Vu T, Wymer JP. Respiratory Strength Training in Amyotrophic Lateral Sclerosis: A Double-Blind, Randomized, Multicenter, Sham-Controlled Trial. Neurology. 2023 Apr 11;100(15):e1634-e1642. doi: 10.1212/WNL.0000000000206830. Epub 2023 Feb 20.
- Ballenger, B., Barry, E., Wang, J., Haxton, C., Deninger, I., Thompson, R., Osman, K. L., & Lever, T. E. (2022). Targeted Electrical Stimulation of the Superior Laryngeal Nerve - A Potential Treatment for Dysphagia in ALS. The FASEB Journal, 36(S1). https://doi.org/https://doi.org/10.1096/fasebj.2022.36.S1.R4239
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Neuromusculaire aandoeningen
- Metabole ziekten
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Neurodegeneratieve ziekten
- Slokdarmaandoeningen
- KNO-ziekten
- Faryngeale ziekten
- Ziekten van het ruggenmerg
- TDP-43 Proteïnopathieën
- Proteostase-tekortkomingen
- Motor Neuron Ziekte
- Voedings- en stofwisselingsziekten
- Verslikkingsstoornissen
- Amyotrofische laterale sclerose
Andere studie-ID-nummers
- 2026-127-NSU
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .