Brain InjuriesNCT05464160

Focal Muscular Vibration in Patients with Severe Acquired Brain Injury

A study testing Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy) and Conventional Rehabilitation in people with Brain Injuries and Spasticity, Muscle, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Severe acquired brain injury (sABI) is a group of disorders that cause long-term disability. Rehabilitation is essential to counteract bed immobilization, muscle failure, pain, and sensory deficits that can affect the clinical and rehabilitation pathway of these patients. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Brain Injuries, Spasticity, Muscle
What is being tested?: Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy) and Conventional Rehabilitation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteItaly
Study dates: 15 Oct 2021to 31 Oct 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 18-75 years
Picture of subacute sABI (20 days to 6 months after the acute event), of any etiology (traumatic, vascular, metabolic)
Presence of spasticity in the affected limb as assessed by the Modified Ashwort Scale (MAS) ≥ 1+

Who cannot join

recent treatment with botulinum toxin (within 3 months);
ongoing treatment with systemic muscle relaxant drugs (baclofen, tizanidine, benzodiazepines);
deep vein thrombosis;
central/peripheral accesses ipsilateral to the limb(s) to be treated;
oncological diseases;
epilepsy;
open skin lesions or local infections.

Trial locations and contacts

1 site in 1 country.

Italy1 site

UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168

Other trials in Italy

About this study

Official title: Focal Muscular Vibration in the Intensive Treatment of Spasticity in Patients with Severe Acquired Brain Injury

Focal muscle vibration (FMV) is a tool that uses low-amplitude, high-frequency vibrations that when applied to muscle-tendon units. This technique, administered at specific frequencies, amplitudes and durations, can generate action potentials of the same frequency as the stimulus applied to the muscle or tendon. This makes it possible to activate selected afferent fibers and stimulate targeted brain areas with persistent effects over time (long-term potentiation).

Regarding the effect of counteracting vibration spasticity, FMV is able to inhibit the reflex arc and induce reciprocal inhibition of functional agonist muscle. In addition, the strong proprioceptive stimulus generated by vibration is able to reach the primary motor and somatosensory cortex, enhancing cortical mechanisms that regulate co-contraction between agonist and antagonist muscles, thereby reducing muscle tone and joint stiffness. In many studies, this technique has been shown to be effective in reducing pain and joint stiffness by improving muscle contraction and motor control.

Read the detailed description

The present study aims to analyze the effects of focal muscle vibration in patients with sABI. This study is innovative for the setting, as it will take place for the first time within a neurorehabilitation hospital ward, for the intensity of the treatment as patients will undergo daily treatment sessions, for longer periods than protocols so far in the scientific literature. Finally, the cortical effects of the vibratory stimulus will be analyzed through the analysis of cortical neurophysiological correlates

Conditions: Brain Injuries, Spasticity, Muscle
Being tested: Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy), Conventional Rehabilitation
Medical subject headings: Brain Injuries, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy)Device
FMV will be applied 7 times per week for 3 weeks (21 total applications), using the "EVM EVO medical device" (Endomedica, Italy), applying an intensity of 100 Hz for a total of 23 minutes.
Conventional RehabilitationOther
Conventional treatment will focus on joint mobilization, muscle stretching, and neuromuscular facilitation activities, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive Neuromuscular Facilitation, etc...)

Study groups in NCT05464160
Study group	Role	What they receive
G-FMV (Group Focal Muscular Vibration)	Experimental	Patients allocated in the G-FMV, in addition to conventional rehabilitation treatment, will be treated for 3 weeks with FMV, applied to the upper and/or lower limb, depending on the clinical status. The G-FMV will perform the treatment at a frequency of 7 times per week for 3 weeks (21 total applications), using the "EVM EVO medical device" (Endomedica, Italy), applying an intensity of 100 Hz for a total of 23 minutes. Specifically, four different trains of stimulation lasting 5 minutes each will be performed, interspersed with 1 minute of rest (20 minutes of treatment + 3 minutes of rest). FMV will be applied on agonist (major spasticity) muscles of the lower limb and/or upper limb, either single-district or multiple-district, according to clinical evidence of intervention. Stimulation will be conducted in a stand-alone session as an adjunctive modality to the rehabilitation project of physiotherapy and occupational therapy. Receives: Device: Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy)
G-CON (Group Conventional)	Active comparator	Patients allocated in the G-CONwill be treated for 3 weeks by specific conventional rehabilitation based on the clinical status. The G-CON will carry out the normal physiotherapy and occupational therapy rehabilitation treatment, as per the rehabilitation project, for an equal total treatment time to the G-FMV. Conventional treatment will focus on joint mobilization, muscle stretching, and neuromuscular facilitation activities, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive Neuromuscular Facilitation, etc...) Receives: Other: Conventional Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction of spasticity, assessed by Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a scale for the assessment of spasticity consisting of 6 different categories, based on the score assigned in relation to the degree of perceived resistance to passive mobilization.
Measured: Change from Baseline MAS at 3 weeks and at 6 weeks

Secondary outcomes (8)

Reduction of disability, assessed by Disability Rating Scale (DRS)
The Disability Rating Scale (DRS) is a assessment tool through which the degree of disability can be assessed. The DRS consists of 4 categories through which a patient's functional level can be identified. For the category "vigilance and responsiveness" can be scored from 0 to 12, for the category "cognitive skills for self-care" the score ranges from 0 to 9, for the category "dependence on others" from 0 to 5, and for the category "social participation" the score ranges from 0 to 3.
The total DRS score ranges from 0 (no disability) to 29 (severe vegetative state).
Measured: Change from Baseline DRS at 3 weeks and at 6 weeks
Reduction of disability, assessed by modified Barthel Index (mBI)
The modified Barthel Index (mBI) is a scale used to assess autonomy in activities of daily living.
It consists of 10 items: "feeding," with a score ranging from 0 to 10; "personal hygiene," with a score ranging from 0 to 5; "bathing or showering," with a score ranging from 0 to 5"; "dressing,",on a score ranging from 0 to 10; "bed/chair transfer," with a score ranging from 0 to 15; "toilet use," with a score ranging from 0 to 10; "bladder," with a score ranging from 0 to 10; "bowel," with a score ranging from 0 to 10; "walking," with a score ranging from 0 to 15; "stairs," with a score ranging from 0 to 10." The mBI score ranges from 0 (fully dependent) to a maximum of 100 (fully dependent).
Measured: Change from Baseline mBI at 3 weeks and at 6 weeks
Reduction of pain, assessed by Faces Pain Scale (FPS)
The FPS is a scale consisting of 11 faces; the faces are represented by an 8 cm × 8 cm black-and-white line drawing. Each face corresponds to a value from 0 (no pain) to 10 (worst possible pain).
Measured: Change from Baseline FPS at 3 weeks and at 6 weeks
Reduction of pain, assessed by Nociception Coma Scale-revised (NCS-r)
The Nociception Coma Scale-revised (NCS-r) is an assessment tool developed and validated for measuring nociception and pain in patients with brain injury.
The NCS consists of four subscales: motor response, verbal response, visual response and facial expression. Each of the subscales is scored from 0 to 3 points, where 3 points equals the maximum possible pain sign for each item. The NCS records the response to noxious stimuli.
Measured: Change from Baseline NCS-r at 3 weeks and at 6 weeks
Reduction of pain, assessed by Critical-Care Pain Observational Tool (C-POT)
The C-POT is a nonverbal pain behavior detection tool specifically for ICU patients. It consists of 4 behavioral indicators: facial expression, body movements, respirator adaptation (for intubated patients) or vocalizations (for non-intubated patients), and body tension. Each indicator has three response options (0, 1, or 2), accompanied by a brief description for correct scoring; the total ranges from 0 to 8 (higher scores indicate more intense pain). A total score greater than 3 indicates clinically relevant pain.
Measured: Change from Baseline C-POT at 3 weeks and at 6 weeks
Reduction of pain, assessed by Pain Assessment IN Advanced Dementia (Painad)
The Painad is a multidimensional scale of pain assessment, used for patients with marked cognitive impairment or uncooperative. The Painad consists of 5 basic parameters: (i) breathing, (ii) vocalization, (iii) facial expression, (iv) body language, and (v) consolation.
A score ranging from 0 to 2 is given for each item, in ascending order of observed discomfort. Finally, the sum of the values obtained from each item is performed going to form a score ranging from 0 to 10. A score of 0 indicates no pain; 1 to 3 mild pain; 4 to 6 moderate pain; 7 to 10 severe pain.
Measured: Change from Baseline Painad at 3 weeks and at 6 weeks
Changes in electrocortical activity, assessed by electroencephalogram (EEG)
The information inherent in the assessment of electrocortical activity, using the electroencephalogram (EEG), asking the patient to move the treated limb (or, if not possible, to imagine the movement). The presence of a cortical potential in motor area will be assessed by following the somatotopic organization, by reconstructing a brain map in amplitude;
Measured: Change from Baseline EEG at 3 weeks and at 6 weeks
Changes in muscle activation, assessed by electromyography (EMG)
Through EMG, it is possible to go and record muscle activity
Measured: Change from Baseline EMG at 3 weeks and at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202131 Oct 2024

First posted19 Jul 2022
Study start15 Oct 2021
Primary completion8 Jul 2022
Study completion31 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Brain InjuriesStudies 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
Masking: Single blind
Who is masked: Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05464160
Sponsor's protocol ID: 4237
Status last verified: Mar 2025
First submitted: 13 Jul 2022
Last updated: 20 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alashram AR, Padua E, Romagnoli C, Annino G. Effectiveness of focal muscle vibration on hemiplegic upper extremity spasticity in individuals with stroke: A systematic review. NeuroRehabilitation. 2019 Dec 18;45(4):471-481. doi: 10.3233/NRE-192863.
PubMed 31868686
Lucente G, Valls-Sole J, Murillo N, Rothwell J, Coll J, Davalos A, Kumru H. Noninvasive Brain Stimulation and Noninvasive Peripheral Stimulation for Neglect Syndrome Following Acquired Brain Injury. Neuromodulation. 2020 Apr;23(3):312-323. doi: 10.1111/ner.13062. Epub 2019 Nov 14.
PubMed 31725939
Marconi B, Filippi GM, Koch G, Giacobbe V, Pecchioli C, Versace V, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair. 2011 Jan;25(1):48-60. doi: 10.1177/1545968310376757. Epub 2010 Sep 12.
PubMed 20834043
Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
PubMed 24842220
Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946.
PubMed 22402727

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Focal Muscular Vibration in the Intensive Treatment of Spasticity in Patients with Severe Acquired Brain Injury
ClinicalTrials.gov ID: NCT05464160
Acronym / sponsor ID: 4237
Conditions: Brain Injuries, Spasticity, Muscle
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
Study start: 15 Oct 2021 (actual)
Primary completion: 8 Jul 2022 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 19 Jul 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
G-FMV (Group Focal Muscular Vibration)	Experimental	Device: Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy)Patients allocated in the G-FMV, in addition to conventional rehabilitation treatment, will be treated for 3 weeks with FMV, applied to the upper and/or lower limb, depending on the clinical status. The G-FMV will perform the treatment at a frequency of 7 times per week for 3 weeks (21 total applications), using the "EVM EVO medical device" (Endomedica, Italy), applying an intensity of 100 Hz for a total of 23 minutes. Specifically, four different trains of stimulation lasting 5 minutes each will be performed, interspersed with 1 minute of rest (20 minutes of treatment + 3 minutes of rest). FMV will be applied on agonist (major spasticity) muscles of the lower limb and/or upper limb, either single-district or multiple-district, according to clinical evidence of intervention. Stimulation will be conducted in a stand-alone session as an adjunctive modality to the rehabilitation project of physiotherapy and occupational therapy.
G-CON (Group Conventional)	Active comparator	Other: Conventional RehabilitationPatients allocated in the G-CONwill be treated for 3 weeks by specific conventional rehabilitation based on the clinical status. The G-CON will carry out the normal physiotherapy and occupational therapy rehabilitation treatment, as per the rehabilitation project, for an equal total treatment time to the G-FMV. Conventional treatment will focus on joint mobilization, muscle stretching, and neuromuscular facilitation activities, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive Neuromuscular Facilitation, etc...)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age between 18-75 years
Picture of subacute sABI (20 days to 6 months after the acute event), of any etiology (traumatic, vascular, metabolic)
Presence of spasticity in the affected limb as assessed by the Modified Ashwort Scale (MAS) ≥ 1+

Key exclusion criteria (7 listed)

recent treatment with botulinum toxin (within 3 months);
ongoing treatment with systemic muscle relaxant drugs (baclofen, tizanidine, benzodiazepines);
deep vein thrombosis;
central/peripheral accesses ipsilateral to the limb(s) to be treated;
oncological diseases;

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
Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy)FMV will be applied 7 times per week for 3 weeks (21 total applications), using the "EVM EVO medical device" (Endomedica, Italy), applying an intensity of 100 Hz for a total of 23 minutes.	Device	G-FMV (Group Focal Muscular Vibration)
Conventional RehabilitationConventional treatment will focus on joint mobilization, muscle stretching, and neuromuscular facilitation activities, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive Neuromuscular Facilitation, etc...)	Other	G-CON (Group Conventional)

Primary outcome

Reduction of spasticity, assessed by Modified Ashworth Scale (MAS)
Time frame: Change from Baseline MAS at 3 weeks and at 6 weeks
The Modified Ashworth Scale (MAS) is a scale for the assessment of spasticity consisting of 6 different categories, based on the score assigned in relation to the degree of perceived resistance to passive mobilization.

8 secondary outcomes

Reduction of disability, assessed by Disability Rating Scale (DRS)
Time frame: Change from Baseline DRS at 3 weeks and at 6 weeks
Reduction of disability, assessed by modified Barthel Index (mBI)
Time frame: Change from Baseline mBI at 3 weeks and at 6 weeks
Reduction of pain, assessed by Faces Pain Scale (FPS)
Time frame: Change from Baseline FPS at 3 weeks and at 6 weeks
Reduction of pain, assessed by Nociception Coma Scale-revised (NCS-r)
Time frame: Change from Baseline NCS-r at 3 weeks and at 6 weeks
Reduction of pain, assessed by Critical-Care Pain Observational Tool (C-POT)
Time frame: Change from Baseline C-POT at 3 weeks and at 6 weeks
Reduction of pain, assessed by Pain Assessment IN Advanced Dementia (Painad)
Time frame: Change from Baseline Painad at 3 weeks and at 6 weeks
Changes in electrocortical activity, assessed by electroencephalogram (EEG)
Time frame: Change from Baseline EEG at 3 weeks and at 6 weeks
Changes in muscle activation, assessed by electromyography (EMG)
Time frame: Change from Baseline EMG at 3 weeks and at 6 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.
Background: PubMed 31868686Alashram AR, Padua E, Romagnoli C, Annino G. Effectiveness of focal muscle vibration on hemiplegic upper extremity spasticity in individuals with stroke: A systematic review. NeuroRehabilitation. 2019 Dec 18;45(4):471-481. doi: 10.3233/NRE-192863.
Background: PubMed 31725939Lucente G, Valls-Sole J, Murillo N, Rothwell J, Coll J, Davalos A, Kumru H. Noninvasive Brain Stimulation and Noninvasive Peripheral Stimulation for Neglect Syndrome Following Acquired Brain Injury. Neuromodulation. 2020 Apr;23(3):312-323. doi: 10.1111/ner.13062. Epub 2019 Nov 14.
Background: PubMed 20834043Marconi B, Filippi GM, Koch G, Giacobbe V, Pecchioli C, Versace V, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair. 2011 Jan;25(1):48-60. doi: 10.1177/1545968310376757. Epub 2010 Sep 12.
Background: PubMed 24842220Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
Background: PubMed 22402727Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946.
Individual participant dataSharing planned: No

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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 Universitaria A. Gemelli IRCCS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 7 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?

Reduction of spasticity, assessed by Modified Ashworth Scale (MAS) (time frame: Change from Baseline MAS at 3 weeks and at 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464160, which also lists 5 linked publications.

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.