Amyotrophic Lateral Sclerosis (ALS)NCT07606235
Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in Patients Living With ALS
A study testing Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in people with Amyotrophic Lateral Sclerosis (ALS) and Dysphagia, run by Nova Southeastern University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Dysphagia, Dystussia
- What is being tested?
- Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of ALS (El-Escorial Criteria)
- ALS FRS Bulbar Subscore of ≤ 10 and ≥ 3.
- Functional Oral Intake scale score ≥ 2
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Dysphagia, Dystussia
- Being tested
- Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to SwallowOther
Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in ALS
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Not described Receives: Other: Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing Frequency
The count of swallows per unit time with predefined epochs
Measured: 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: Measured from enrollment to the end of the 7 day follow up period
Secondary outcomes (7)
Body weight gain/loss
The total body weight (lbs)
Measured: At Day 1 and at Day 7
Maximum Expiratory Pressure
Maximum expiratory pressure achieved during forceful exhalation
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Day 1 - Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Curators of the University of Missouri
- Responsible party
- Sponsor
- Investigators
- Lauren Tabor Gray, Ph.D CCC-SLP, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606235
- Sponsor's protocol ID
- 2026-127-NSU
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27752517Tabor 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
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.
PubMed 30250869Plowman 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.
PubMed 26599236Plowman 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.
PubMed 29981250Plowman 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.
PubMed 36805435Ballenger, 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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in Patients Living With ALS
- ClinicalTrials.gov ID
- NCT07606235
- Acronym / sponsor ID
- 2026-127-NSU
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Dysphagia, Dystussia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Curators of the University of Missouri
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of ALS (El-Escorial Criteria)
- ALS FRS Bulbar Subscore of ≤ 10 and ≥ 3.
- Functional Oral Intake scale score ≥ 2
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to SwallowTranscutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in ALS | Other | Interventional Group |
Primary outcome
Swallowing Frequency
Time frame: 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
Time frame: 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)
7 secondary outcomes
Body weight gain/loss
Time frame: At Day 1 and at Day 7
Maximum Expiratory Pressure
Time frame: From enrollment to the end of the 7-day follow up period
Lingual pressure assessment
Time frame: At baseline (Day 1) pre-procedural, on Day 1 post-procedure, and on Day 7
Peak cough flow
Time frame: One at enrollment and one at the end of the 7- day folow-up period
Videofluoroscopic Swallowing Evaluation
Time frame: At baseline and at the end of the 7-day follow-up period
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Time frame: At baseline and again at the end of the 7 day follow up period
Body Weight (BMI)
Time frame: Day 1 - Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 27752517Tabor 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.
- BackgroundTabor 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
- Background: PubMed 30250869Robison 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.
- Background: PubMed 26599236Plowman 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.
- Background: PubMed 29981250Plowman 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.
- Background: PubMed 36805435Plowman 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.
- BackgroundBallenger, 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
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Tabor Gray, Ph.D CCC-SLP principal investigator
Nova Southeastern University
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in people with Amyotrophic Lateral Sclerosis (ALS) and Dysphagia, run by Nova Southeastern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Racquel Garcia, SLPD, CCC-SLP ((954) 262-1271, rw602@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing Frequency (time frame: From enrollment to the end of the 7-day follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07606235, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.