Acquired Brain InjuryNCT05729165
Local Vibration in Patients with Severe Acquired Brain Injury
A study testing Novafon® Pro and Conventional Therapy in people with Acquired Brain Injury and Dysphagia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acquired Brain Injury, Dysphagia
- What is being tested?
- Novafon® Pro and Conventional Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 29 Oct 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous coma
- Age between 18 and 90 years
- Level of consciousness greater than or equal to Minimally Conscious State plus
- Feeding through SNG or PEG
- Clinical stability
- Ability of caregiver/legal guardian to understand and sign informed consent
Who cannot join
- Psychiatric or other conditions that may affect patient compliance with treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168
About this study
Official title: Local Vibration Therapy and Traditional Speech Therapy for Dysphagia in Patients with Severe Acquired Brain Injury
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.
Read more
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.
Read the detailed description
The purpose of the present study is to observe the effects of integrating traditional speech therapy with the new intervention modality of local vibration therapy with Novafon® in patients with sABI.
Specifically, this study aims to:
(i) Observe and record an increase in trophism of the muscles involved; (ii) improve swallowing and phonatory functions. Twenty-four patients of both sexes with sABI will be recruited, evaluated and treated at the UOC of High Intensity Neurorehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.
Participants included in the study will be randomized into two groups according to a computer-generated sequence: patients in the experimental group (S-G) will perform traditional speech therapy combined with speech therapy using Novafon®; patients in the conventional group (C-G) will perform only traditional speech therapy.
The experimental rehabilitation treatment will be carried out at the rate of once a day, 5 days a week for a total of 8 weeks. Each speech therapy session will last a total of 40 minutes.
The rehabilitation treatment will be carried out in the room of the patient, who will be placed in a sitting position in a wheelchair or bed, with the backrest inclined at least 45°.
- Conditions
- Acquired Brain Injury, Dysphagia
- Being tested
- Novafon® Pro, Conventional Therapy
- Keywords
- Acquired Brain Injury, Dysphagia, Local vibration, Technological Rehabilitation
- Medical subject headings
- Brain Injuries, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novafon® ProDevice
Local vibration therapy. The target muscles were: the orbicularis muscles of the upper and lower lips, the masticatory muscles (masseter, temporalis, pterygoidis) and lingual muscles.
Conventional TherapyOther
maneuvers were performed for passive extra-oral and intra-oral thermal stimulation, passive extra-oral and intra-oral tactile stimulation, and elicitation of active movements of the bucco-lingual and pharyngo-laryngeal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (S-G) | Experimental | 20 minutes of local vibration treatment with the Novafon® Pro medical device followed by 20 minutes of traditional speech therapy, for a total duration of 40 minutes. Therefore, using this instrument, local vibration therapy will be applied at the level of (i) the orbicular muscles of the upper and lower lips, (ii) the masticatory muscles (masseter, temporalis, pterygoid), and (i) local intra-oral and tongue. The Novafon® Pro medical device will be used with the following external and intraoral heads: set senses roller, ball head, disc head, ball head, arrow head, spoon head, and tongue depressor head.
Traditional speech therapy treatment will be carried out with the same tools and activities already described in the C-G. Receives: Device: Novafon® Pro; Other: Conventional Therapy |
| Control group (C-G) | Active comparator | 40 minutes of conventional speech treatment. Specifically, maneuvers will be performed for (i) extra-oral and intra-oral passive thermal stimulation, (ii) extra-oral and intra-oral passive tactile stimulation, and for (iii) elicitation of active bucco-lingual and laryngeal muscle movements. The following instruments will be used for this purpose: ice cubes, ice tubes, sterile gauze, tongue depressors, swabs, 10 mm laryngeal mirrors. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia Outcome and Severity Scale (DOSS)
DOSS is a 7-point functional dysphagia rating scale (from 1 severe dysphagia with the need for artificial feeding, to 7 swallowing in the normal range and exclusive oral feeding), which provides recommendations regarding the type of diet/nutrition to be followed and the level of independence. The progress of this 7-point scale reflects an improvement in the level of dependence in feeding (form 0, "total dependence" to 7, "self-sufficient patient"), level of nutrition (levels 7-3 full oral nutrition and levels 2-1 non-oral nutrition) and type of diet according to different food consistencies (levels 7-6 normal diet consistency, level 5 may need one diet consistency restriction, level 4 one to two diet consistency restrictions, and level 3 two or more diet consistency restrictions). The aspects considered by this scale are bolus management in the oral phase, pharyngeal phase retention and ability to protect the airway.
Measured: Change from baseline DOSS at 4 and 8 weeks
Secondary outcomes (3)
Bedside Swallow Assessment scale (BSAs)
BSAs is a tool with a minimum score of 19 in case of adequate swallowing function and a maximum score of 48 indicating severe discomfort. It is divided into three parts:
- level of consciousness, trunk and head control, respiration, structures of the phono-articulatory and swallowing apparatus;
- direct evaluation of swallowing by administering 5 ml of water and recording laryngeal movements with attempts to swallow, repetitive movements, the presence or absence of coughing during swallowing and the presence of gurgling voice after swallowing;
- administration of 60 ml of water, recording the time required to finish, the number of sips, the presence of coughing, the presence of gurgling voice.
A scale value < 19 reflects the inability to perform part of the tests, particularly the third part with water administration, due to risk of aspiration, inability or lack of cooperation from the patient.
Measured: Change from baseline BSAs at 4 and 8 weeks
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
FEES is a highly sensitive and useful examination to obtain information on the anatomical rhino-pharyngeal-laryngeal structures, swallowing mechanism, pharyngeal motility, and sensitivity of the pharyngeal-laryngeal tract. FEES does not allow direct verification of whether aspiration is present, but the risk of aspiration can be detected by the presence of post-deglutition stagnation in the laryngeal vestibule.
Measured: Change from baseline FEES at 4 and 8 weeks
Phonation
Phonation will be assessed through the use of a sound level meter, an instrument that can identify the decibels (dB) of phonation.
Measured: Change from baseline phonation at 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start29 Oct 2021
- Primary completion30 Apr 2022
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, randomized, parallel assigment
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PADUA LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luca Padua, MD, phD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729165
- Sponsor's protocol ID
- 0038189/21
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Vibration Therapy and Traditional Speech Therapy for Dysphagia in Patients with Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT05729165
- Acronym / sponsor ID
- 0038189/21
- Conditions
- Acquired Brain Injury, Dysphagia
- Keywords
- Acquired Brain Injury, Dysphagia, Local vibration, Technological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the present study is to observe the effects of integrating traditional speech therapy with the new intervention modality of local vibration therapy with Novafon® in patients with sABI.
Specifically, this study aims to:
(i) Observe and record an increase in trophism of the muscles involved; (ii) improve swallowing and phonatory functions. Twenty-four patients of both sexes with sABI will be recruited, evaluated and treated at the UOC of High Intensity Neurorehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.
Participants included in the study will be randomized into two groups according to a computer-generated sequence: patients in the experimental group (S-G) will perform traditional speech therapy combined with speech therapy using Novafon®; patients in the conventional group (C-G) will perform only traditional speech therapy.
The experimental rehabilitation treatment will be carried out at the rate of once a day, 5 days a week for a total of 8 weeks. Each speech therapy session will last a total of 40 minutes.
The rehabilitation treatment will be carried out in the room of the patient, who will be placed in a sitting position in a wheelchair or bed, with the backrest inclined at least 45°.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, randomized, parallel assigment
| Arm | Type | Receives |
|---|---|---|
| Experimental group (S-G) | Experimental | Device: Novafon® Pro, Other: Conventional Therapy20 minutes of local vibration treatment with the Novafon® Pro medical device followed by 20 minutes of traditional speech therapy, for a total duration of 40 minutes. Therefore, using this instrument, local vibration therapy will be applied at the level of (i) the orbicular muscles of the upper and lower lips, (ii) the masticatory muscles (masseter, temporalis, pterygoid), and (i) local intra-oral and tongue. The Novafon® Pro medical device will be used with the following external and intraoral heads: set senses roller, ball head, disc head, ball head, arrow head, spoon head, and tongue depressor head. Traditional speech therapy treatment will be carried out with the same tools and activities already described in the C-G. |
| Control group (C-G) | Active comparator | Other: Conventional Therapy40 minutes of conventional speech treatment. Specifically, maneuvers will be performed for (i) extra-oral and intra-oral passive thermal stimulation, (ii) extra-oral and intra-oral passive tactile stimulation, and for (iii) elicitation of active bucco-lingual and laryngeal muscle movements. The following instruments will be used for this purpose: ice cubes, ice tubes, sterile gauze, tongue depressors, swabs, 10 mm laryngeal mirrors. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previous coma
- Age between 18 and 90 years
- Level of consciousness greater than or equal to Minimally Conscious State plus
- Feeding through SNG or PEG
- Clinical stability
Key exclusion criteria (1 listed)
- Psychiatric or other conditions that may affect patient compliance with treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novafon® ProLocal vibration therapy. The target muscles were: the orbicularis muscles of the upper and lower lips, the masticatory muscles (masseter, temporalis, pterygoidis) and lingual muscles. | Device | Experimental group (S-G) |
| Conventional Therapymaneuvers were performed for passive extra-oral and intra-oral thermal stimulation, passive extra-oral and intra-oral tactile stimulation, and elicitation of active movements of the bucco-lingual and pharyngo-laryngeal muscles. | Other | Control group (C-G), Experimental group (S-G) |
Primary outcome
Dysphagia Outcome and Severity Scale (DOSS)
Time frame: Change from baseline DOSS at 4 and 8 weeks
DOSS is a 7-point functional dysphagia rating scale (from 1 severe dysphagia with the need for artificial feeding, to 7 swallowing in the normal range and exclusive oral feeding), which provides recommendations regarding the type of diet/nutrition to be followed and the level of independence. The progress of this 7-point scale reflects an improvement in the level of dependence in feeding (form 0, "total dependence" to 7, "self-sufficient patient"), level of nutrition (levels 7-3 full oral nutrition and levels 2-1 non-oral nutrition) and type of diet according to different food consistencies (levels 7-6 normal diet consistency, level 5 may need one diet consistency restriction, level 4 one to two diet consistency restrictions, and level 3 two or more diet consistency restrictions). The aspects considered by this scale are bolus management in the oral phase, pharyngeal phase retention and ability to protect the airway.
3 secondary outcomes
Bedside Swallow Assessment scale (BSAs)
Time frame: Change from baseline BSAs at 4 and 8 weeks
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Time frame: Change from baseline FEES at 4 and 8 weeks
Phonation
Time frame: Change from baseline phonation at 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Acquired Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Padua, MD, phD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novafon® Pro and Conventional Therapy in people with Acquired Brain Injury and Dysphagia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia Outcome and Severity Scale (DOSS) (time frame: Change from baseline DOSS at 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.