NCT05729165

Local Vibration in Patients with Severe Acquired Brain Injury

Completed NA Last updated 20 March 2025

What this trial tests

NA trial testing Novafon® Pro in Acquired Brain Injury in 24 participants. Completed in 1 June 2024.

Timeline

29 October 2021

Primary endpoint
30 April 2022

1 June 2024

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	29 October 2021
Primary completion	30 April 2022
Estimated completion	1 June 2024
Sites	1 location across Italy

Drugs / interventions tested

• Novafon® Pro
• Conventional Therapy — full drug profile →

Conditions studied

• Acquired Brain Injury — all drugs for Acquired Brain Injury →
• Dysphagia — all drugs for Dysphagia →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Adults 18 to 90, any sex, with Acquired Brain Injury or Dysphagia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Severe Acquired Brain Injury (sABI), with a more or less prolonged state of coma, generally causes disruption of the physiological modes of swallowing and feeding and the physiological abilities of communication and phonation.

There is broad agreement in the scientific literature for early intervention by the entire rehabilitation team. In the specific case of swallowing and phonatory function, speech therapist intervention is indicated with the goal of restoring the automatic and voluntary movements of the muscles involved in the performance of the previously mentioned functions.

Speech-language treatment of buccal structures, sensation, motor and praxie is recommended in conjunction with other types of approaches (dietary modifications, compensation techniques, postural modifications).

In the acute and early subacute phase of patients with sABI with a vigilance level of less than 4 according to the Levels of Cognitive Functioning scale, alterations in bucco-linguo-facial structures and swallowing can be observed that prevent the execution of a correct motor pattern of phonation and swallowing. For this reason, passive and/or active stimulation aimed at restoring sensitivity, strength, and movement coordination of the bucco-linguo-facial and laryngeal muscles is necessary to rehabilitate the prerequisites for the initiation of feeding, to restore adequate afferents, and to stimulate communication.

A careful search of the literature shows that over the past decade many studies in the rehabilitation field have sought to understand the effects of local vibration therapy at various levels of the central nervous system and the possible benefits in neurorehabilitation. From a speech therapy perspective, there are only three studies on the area of dysphonia in cases of upper laryngeal nerve palsy, combining traditional treatment with the use of Novafon®, a sound wave medical device used for Local Vibrational Therapy. The results show greater improvements in vocal function and voice quality when classical treatment is combined with Local Vibrational Therapy. These studies conclude by affirming the need for further research with a larger sample size to analyze the potential effectiveness of Novafon® applied to the recovery of vocal cord paralysis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.