NCT07606235Not yet recruiting
Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in Patients Living With ALS
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- Jun 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Nova Southeastern University
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07606235
What you commit to
- Study type: Interventional
- Planned participants: 5
- From Jun 2026 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A diagnosis of significant cognitive impairment or frontotemporal dementia per the treating neurologist or neuropsychologist,
- Pacemaker or implanted defibrillator or history of diagnosed arrhythmia, bradycardia, or repeated attacks of hypotension,
- History of epilepsy
- Infected, broken or inflamed skin on the neck, or impaired sensation at the site of sEMG or TENS placement
Other
- Current nasogastric tube placement
- Current head and neck carcinoma
- Implanted vagal nerve stimulator
- Current pregnancy
- 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.
Who the study is looking for
- Confirmed diagnosis of ALS (El-Escorial Criteria)
- ALS FRS Bulbar Subscore of ≤ 10 and ≥ 3.
- Functional Oral Intake scale score ≥ 2
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.