Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge t… (NCT07606235) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in Patients Living With ALS
5 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Swallowing Frequency
Timeframe: From enrollment to the end of the 7-day follow-up period
2
Urge-to-swallow
Timeframe: Measured from enrollment to the end of the 7 day follow up period