Effectiveness of Transcutaneous NMES as an Adjunct for Swallowing Disorders in Tracheotomized Patients

NCT07529210 | Not Yet Recruiting

• 1 other identifier: 2024-A01576-41
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dysphagia can reach a prevalence of up to 80% in intensive care patients. The implementation or prolonged presence of medical devices such as the intubation tube, tracheostomy, or nasogastric tube alters the physiology of swallowing and causes local injuries at several levels. Additionally, certain medical treatments impair swallowing physiology and the patient's alertness, further promoting the development of these disorders. Management of dysphagia involves two main types of strategies: adaptive or compensatory maneuvers and rehabilitation techniques such as: performing praxis or swallowing exercises; physical stimulation (tactile or thermal); transcranial stimulation (electrical or magnetic); and finally, pharyngeal or transcutaneous electrical stimulation (NMES). Patients hospitalized in intensive care often present with altered levels of alertness, asynchronous ventilation and swallowing, and reduced motor capabilities, making it difficult to perform techniques like praxis, food trials, or resistance swallowing exercises. NMES does not require active patient cooperation or the permanent presence of the therapist during the stimulation session, thus increasing the intensity of dysphagia rehabilitation and the early implementation of treatment in these patients, complementing conventional rehabilitation. Muscle and sensory stimulation through the application of NMES can help increase the strength of the muscles involved in swallowing and improve sensory capabilities. However, its effects have not yet been evaluated in tracheostomized patients undergoing weaning from prolonged mechanical ventilation.

Conditions

Dysphagia; NeuroMuscular Electrical Stimulation

Keywords

Deglutition

Outcome Measures

Primary Outcomes (1)

• Prevalence of swallowing disorders after 21 days of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments, in patients following tracheotomy due to prolonged mechanical ventilation weaning

  Evaluate the effectiveness of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments for swallowing disorders, on the prevalence of these disorders after 21 days of treatment, in patients who have undergone tracheotomy due to prolonged mechanical ventilation weaning.

  after 21 days of treatment

Secondary Outcomes (7)

• Severity of swallowing disorders - the yale pharyngeal residue severity rating scale

  21 days

• Time to resume oral feeding at Day 21 after NMES initiation

  At day 21 after initiation of NMES/placebo

• Duration of mechanical ventilation

  Day 21 after initiation of NMES treatment/placebo

• Lenght of stay

  From study inclusion (Day 0) until discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days)

• Time to tracheostomy decannulation

  From study inclusion (Day 0) until tracheostomy decannulation, assessed up to study completion (approximately 30 days)

Study Arms (2)

Placebo Neuromuscular Electrical Stimulation (Placebo NMES)

PLACEBO COMPARATOR

Patients included in the control group will receive standard care and the control intervention. The Neuro Muscular Electrical Stimulation (NMES) will be applied through 2 pairs of electrodes to the anterior surface of the neck. The same frequency and pulse duration will be used. The intensity will be increased until a vibration/tingling sensation perceptible by the patient is produced. The device will then be turned off.

Procedure: Placebo Neuromuscular Electrical Stimulation (Placebo NMES)

Neuromuscular Electrical Stimulation (NMES)

EXPERIMENTAL

The patient is comfortably positioned on their back, with the backrest at a 45° incline. Neuromuscular electrical stimulation (NMES) is applied through two pairs of electrodes placed on the front of the neck: one pair on the supra-hyoid muscles and the other on the infra-hyoid muscles. The electrodes are positioned using anatomical landmarks of the hyoid bone and the mandible. A current of 80 Hz with a pulse duration of 700 µs is applied to induce a muscle contraction. The treatment begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, 5 days a week. The treatment is performed once per day. Let me know if you need further adjustments or explanations!

Procedure: Neuromuscular Electrical Stimulation (NMES)

Interventions

Neuromuscular Electrical Stimulation (NMES) PROCEDURE

The patient will be comfortably positioned on their back, with the backrest inclined at 45°. NMES will be applied via two pairs of electrodes on the anterior neck. One pair of electrodes will be placed on the suprahyoid muscles and the other on the infrahyoid muscles. The treatment begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, five days per week. The treatment is administered once per day. Each department is encouraged to identify a time slot to facilitate the organization of care and avoid non-completion of the treatment. The duration of the session and the frequency of the intervention's application were chosen based on data from a recent systematic review of randomized controlled trials comparing the effectiveness of NMES versus conventional treatment. The included studies mostly had session durations around 30 minutes, 2 to 5 times per week, for a period of 2 to 6 weeks.

Neuromuscular Electrical Stimulation (NMES)

Placebo Neuromuscular Electrical Stimulation (Placebo NMES) PROCEDURE

NMES will be applied via two pairs of electrodes on the anterior neck. Two electrodes will be placed above the hyoid bone, on either side, between the hyoid bone and the mandible. The other two electrodes will be placed on either side of the thyroid cartilage. The patient will also be comfortably positioned in a supine position, with the backrest inclined at 45°. The same frequency and pulse duration will be used. The intensity will be increased until the patient perceives a vibrating/tingling sensation. The device will then be turned off. The control intervention begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, five days per week. The treatment is administered once per day at a time slot chosen by each center.

Placebo Neuromuscular Electrical Stimulation (Placebo NMES)

Eligibility Criteria

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

You may qualify if:

• Hospitalized in intensive care units, post-ICU rehabilitation, or weaning and rehabilitation services;
• Presence of a tracheostomy for more than 72 hours due to difficult mechanical ventilation weaning;
• Diagnosis of swallowing disorders (swallowing fiberoscopy);
• Affiliated to a social security scheme or beneficiary of such a scheme;
• Written, free and informed consent of the patient or their next of kin.

You may not qualify if:

• Contra- indication to cervical NMES;
• History of swallowing disorders;
• Patient with a spinal cord injury above C5 level;
• History of head and neck cancer;
• Person under legal protection measures;
• Patient under guardianship or conservatorship;
• Known pregnancy;
• Limitation of care.

Sponsors & Collaborators

• Hopital Forcilles: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Carlos Diaz Lopez

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aymeric PhD LE NEINDRE

CONTACT

+33160646093; aleneindre@cognacq-jay.fr

Andreia GOMES LOPES

CONTACT

+33160646293; alopes@cognacq-jay.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: April 14, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04