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Tongue-Strengthening Exercises for ALS

This study is testing a tongue exercise program called Isometric Lingual Strength Exercises for people with Amyotrophic Lateral Sclerosis (ALS). The goal is to see if these exercises can help improve speech and swallowing. You might be able to join if you have a diagnosis of possible, probable, or definite ALS, have not done lingual exercises before, and have weaker tongue strength than normal. Researchers will measure your maximum tongue strength and assess your swallowing safety and efficiency using a Videofluoroscopic Swallow Study. All participants will receive the exercise program, and your progress will be compared to your own starting measurements. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study where all 20 participants will receive the Isometric Lingual Strength Exercises. Each participant will serve as their own control, meaning their results will be compared to their own measurements taken before the exercises began.
What's involved
You will have two in-person visits and four weekly telehealth sessions with a speech-language pathologist. You will also do tongue resistance exercises at home five days a week for five weeks, using a small device to measure your tongue strength.
Compensation
Not stated in the trial record.
Follow-up
Your tongue strength will be measured at enrollment, after 5 weeks, and then at home. Swallowing safety and efficiency will be assessed at baseline, week 1, and week 10.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07295990

Tongue-strengthening Exercises in People With ALS.

Recruiting
NAAges 18–99InterventionalTreatment
Nova Southeastern University
~20 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Isometric Lingual Strength Exercises

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Anterior Isometric Lingual Pressure Measured Using the TongueMeter Device
Measured over Participant will start using the tongue meter from day of enrollment. Baseline 1 : MAIP collected , Baseline 2: 5 weeks after baseline , then MAIP calculated at home , intensity of exercise set at 60% MAIP, 5 weeks of exercise at 60% MAIP
+1 more outcome measured

Conditions

ALS (Amyotrophic Lateral Sclerosis)
ALS - Amyotrophic Lateral Sclerosis

Explore related trials

Amyotrophic Lateral Sclerosis

NCT07295990

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Nova Southeastern University

    Davie, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lauren Tabor Gray, Ph.D. · PRINCIPAL_INVESTIGATOR · Neuroscience Institute, Cathy J. Husman ALS Center

Who to contact

Raquel Garcia, SLP.D.
[email protected]
17863994053
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited)
Lingual exercises naïve
Impaired lingual strength generation compared to normative data
EAT-10 score \<3

Exclusion

Stroke
Head injury
Head and neck cancer
Tracheostomy
Other concomitant neurogenic disorder
Recent oral surgery other than routine dental surgery
Unable to generate isometric lingual pressure on lingual manometer
Participation in another clinical trial intervention that may confound results
NPO (nothing by mouth)
Anarthric

What this trial measures

  • Maximum Anterior Isometric Lingual Pressure Measured Using the TongueMeter DeviceParticipant will start using the tongue meter from day of enrollment. Baseline 1 : MAIP collected , Baseline 2: 5 weeks after baseline , then MAIP calculated at home , intensity of exercise set at 60% MAIP, 5 weeks of exercise at 60% MAIP

    Measurement Tool: Lingual pressure is measured using the TongueMeter, a handheld, pressure-sensing device designed to quantify tongue strength during isometric tasks. A calibrated intraoral pressure sensor is positioned against the hard palate. Participants are instructed to press the tongue upward with maximal effort for a standardized duration, and the device records the resulting pressure output. Unit of Measure: Lingual strength is quantified as peak pressure, reported in kilopascals (kPa). Outcome Variable: The primary outcome is the maximum peak lingual pressure (kPa) achieved across trials, with higher values indicating greater lingual strength

  • Videofluoroscopic Swallow StudyBaseline, Visit 1 (week 1), and Final Visit (week 10)swallowing safety/efficiency via DIGEST and PAS scores

    This measure assesses swallowing safety and efficiency in participants using standardized VFSS trials. Safety is quantified using the Penetration-Aspiration Scale (PAS) to capture airway compromise, while swallowing efficiency is measured with the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST), which integrates residue severity and functional impact. Unit of Measure: PAS score for each swallow (ordinal 1-8) DIGEST grade for overall swallowing function (ordinal 0-4) Outcome Variable: The primary outcome is the frequency and severity of airway compromise (PAS) and overall dysphagia severity (DIGEST) during VFSS. Higher PAS and DIGEST scores indicate worse swallowing safety and efficiency.