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| Name | Class |
|---|---|
| Curators of the University of Missouri | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow | Other | Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in ALS |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing Frequency | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight gain/loss | The total body weight (lbs) | At Day 1 and at Day 7 |
| Maximum Expiratory Pressure | Maximum expiratory pressure achieved during forceful exhalation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Racquel Garcia, SLPD, CCC-SLP | Contact | (954) 262-1271 | rw602@nova.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Tabor Gray, Ph.D CCC-SLP | Nova Southeastern University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27752517 | Background | 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. | |
| Background | 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 | ||
| 30250869 |
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Data will be shared with the NSU study team and study collaborators. This includes Dr. Teresa Lever and Mario Awadala (University of Missouri). A clinical trial agreement is established to share this data, and verbiage is included in the informed consent document to inform participants of this agreement.
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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.
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| From enrollment to the end of the 7-day follow up period |
| Lingual pressure assessment | 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 | 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 | 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) | 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) | Total BMI measured at Baseline (day 1) and at the end of th study (Day 7) | Day 1 - Day 7 |
| Background |
| 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. |
| 26599236 | Background | 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. |
| 29981250 | Background | 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. |
| 36805435 | Background | 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. |
| Background | 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 |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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