Tongue-strengthening Exercises in People With ALS.

NCT07295990 | Not Yet Recruiting

• 1 other identifier: Dysphagia Exercise ALS
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is testing a tongue exercise program for people living with ALS to see if it can help support speech and swallowing. All participants will receive the treatment, and researchers will measure changes over time by comparing each person's results to their own earlier results. People who join the study will have two in-person visits, one virtual visit, and four weekly telehealth sessions with a speech-language pathologist. During these sessions, participants will practice tongue resistance exercises, complete speech and swallowing tasks, and answer surveys about their experience. They will also use a small device at home to measure tongue strength and swallowing. The exercise program involves pressing the tongue against a device several times a day, five days per week, for five weeks. Researchers want to learn if this program is safe, practical, and helpful for people with ALS.

Conditions

ALS - Amyotrophic Lateral Sclerosis

Keywords

ALS; Amyotrophic Lateral Sclerosis; Dysphagia; Dysarthria

Outcome Measures

Primary Outcomes (2)

• Maximum Anterior Isometric Lingual Pressure Measured Using the TongueMeter Device

  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

  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

• Videofluoroscopic Swallow Study

  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.

  Baseline, Visit 1 (week 1), and Final Visit (week 10)swallowing safety/efficiency via DIGEST and PAS scores

Secondary Outcomes (5)

• EAT-10

  From enrollment to the end of treatment at 10 weeks.

• Test of Mastication and Swallowing Solids

  From enrollment to the end of treatment at 10 weeks.

• ALS Functional Rating Scale

  From enrollment to the end of treatment at 10 weeks.

• The Eating Tool Burden Questionnaire

  To be given during at week 5 (baseline 2) and week 10 (final)

• Temporal Variability of Oral Diadochokinesis

  From enrollment to the end of treatment at 10 weeks.

Study Arms (1)

Dysphagia Exercise Intervention

EXPERIMENTAL

This study arm will test a proactive dysphagia exercise program using lingual manometry and isometric lingual strength training in people with ALS (pALS). The intervention is designed to maximize lingual strength, improve speech intelligibility, enhance swallow safety and efficiency, and support patient-reported swallowing and quality-of-life outcomes in individuals with minimal decline in tongue function.

Procedure: Isometric Lingual Strength Exercises

Interventions

Isometric Lingual Strength Exercises PROCEDURE

Direct intervention will consist of an isometric lingual exercise program designed specifically for patients with ALS. Participants will complete five exercise sessions per week for a total of five weeks, with each session including six sets of five repetitions (30 repetitions daily, 150 repetitions weekly). Exercises will be performed at 60% of each participant's maximum isometric anterior lingual pressure (MAIP), with each tongue press held for approximately two seconds. Training thresholds will be adjusted weekly via telehealth to ensure the program remains at the prescribed 60% intensity, supporting both safety and consistency in progression. This structured protocol is intended to maximize lingual strength, swallow function, and overall adherence to the intervention.

Dysphagia Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited)
• Lingual exercises naïve
• Impaired lingual strength generation compared to normative data (\<43 kPa; Robinson et al., 2023)
• EAT-10 score \<3

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Deglutition Disorders; Dysarthria

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauren Tabor Gray, Ph.D.

  Neuroscience Institute, Cathy J. Husman ALS Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Garcia, SLP.D

CONTACT

17863994053; rw602@nova.edu

Lauren Tabor Gray, Ph.D.

CONTACT

9549145447; lauren.taborgray@nova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Delayed start, repeated-measures design,

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be disseminated in open access publication.
• Access Criteria: Data will be disseminated in open access publication.