Clinical trial NCT05464160: Focal Muscular Vibration in Patients with Severe Acquired Brain Injury
Official title: Focal Muscular Vibration in the Intensive Treatment of Spasticity in Patients with Severe Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Spasticity, Muscle
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Eligibility criteria: Inclusion Criteria:

* 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+

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reduction of spasticity, assessed by Modified Ashworth Scale (MAS)
timeFrame: Change from Baseline MAS at 3 weeks and at 6 weeks
Secondary outcomes:
measure: Reduction of disability, assessed by Disability Rating Scale (DRS)
timeFrame: Change from Baseline DRS at 3 weeks and at 6 weeks
measure: Reduction of disability, assessed by modified Barthel Index (mBI)
timeFrame: Change from Baseline mBI at 3 weeks and at 6 weeks
measure: Reduction of pain, assessed by Faces Pain Scale (FPS)
timeFrame: Change from Baseline FPS at 3 weeks and at 6 weeks
measure: Reduction of pain, assessed by Nociception Coma Scale-revised (NCS-r)
timeFrame: Change from Baseline NCS-r at 3 weeks and at 6 weeks
measure: Reduction of pain, assessed by Critical-Care Pain Observational Tool (C-POT)
timeFrame: Change from Baseline C-POT at 3 weeks and at 6 weeks
measure: Reduction of pain, assessed by Pain Assessment IN Advanced Dementia (Painad)
timeFrame: Change from Baseline Painad at 3 weeks and at 6 weeks
measure: Changes in electrocortical activity, assessed by electroencephalogram (EEG)
timeFrame: Change from Baseline EEG at 3 weeks and at 6 weeks
measure: Changes in muscle activation, assessed by electromyography (EMG)
timeFrame: Change from Baseline EMG at 3 weeks and at 6 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitaria A. Gemelli IRCCS
name: Luca Padua, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.