Clinical trial NCT05094999: Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury
Official title: Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injuries
Keywords: traumatic brain injuries
proprioceptive stimulation
vibration
spasticity
intensive care units
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: "Severe traumatic brain injury (TBI) is a serious condition, common in young adults. It leads to sensorimotor and cognitive sequelae that hinder social reintegration. Neuronal plasticity must be used quickly before natural recovery impedes neuronal regrowth. In this respect, stopping sedation as soon as possible and early mobilization, even if the patients are unconscious, are recognized as useful measures to promote recovery. However, at the early stage, the environment of the ICU and the acute condition of the patients limit the rehabilitation possibilities. In such a context, functional proprioceptive stimulations (Vibramoov™ system, Techno Concept, France) could be a tool of interest.

By using the proprioceptive signatures of cyclic movements, proprioceptive stimulations can elicit the illusion of these movements. A motor response can even be obtained through the interactions between the peripheral nervous system and the central nervous system. Finally, such stimulations facilitate the initiation of the mimicked movements. Some studies have already shown the benefits of proprioceptive vibrations. However, so far, these benefits have only been studied at the chronic stage of neurological diseases. The investigators hypothesized that early functional proprioceptive stimulations (FPS) may reduce spasticity and promote recovery in patients with severe traumatic brain injury.

To test the hypothesis, the investigators conduct a randomized controlled trial on patients with severe traumatic brain injury. Every patient will be included as soon as possible in the ICU and receive either FPS, either sham stimulations to the joints of the lower limbs, 4 times a week during 8 weeks. The primary outcome measures will assess spasticity. The investigators also assess pain, coma recovery; muscle wasting and cognitive impairments. "


Eligibility criteria: Inclusion Criteria:

* Severe TBI : Glasgow coma score (GCS) ≤ 8 (11)
* Age ≥ 18 years old
* No pregnancy
* Not being under guardianship
* Be affiliated to the French social security system

Exclusion Criteria:

* Orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury
* Traumatic SCI

Primary outcomes:
measure: Changes in the modified Ashworth scale (MAS)
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
measure: Changes in the angles of the muscle reaction in the modified Tardieu scale (MTS)
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
measure: Changes in the quality of the muscle reaction in the modified Tardieu scale (MTS)
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
measure: Changes in the Spinal cord assessment tool for spastic reflexes (SCATS)
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
Secondary outcomes:
measure: Changes in the visual analog scale for the auto-assessment of problematic spasticity
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
measure: Changes in the visual analog scale for the auto-assessment of problematic spasticity
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury
measure: Changes in the Coma recovery scale-revised (CRS-R)
timeFrame: At inclusion, and at one month, 2 months and 1 year after the injury.
measure: Changes in the Glasgow outcome scale (GOS)
timeFrame: At inclusion, and at one month, 2 months and 1 year after the injury.
measure: Changes in the Glasgow outcome scale-extended (GOS-E)
timeFrame: At inclusion, and at one month, 2 months and 1 year after the injury.
measure: Changes in the Disability rating scale (DRS)
timeFrame: At inclusion, and at one month, 2 months and 1 year after the injury.
measure: Changes in the quadriceps muscle thickness
timeFrame: At inclusion, then once a week during the first month, and at 2 months, 6 months and 1 year after the injury
measure: Changes in the Montreal cognitive assessment (MoCA)
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
measure: Changes in the time to complete the bells cancellation test to assess cognitive impairments
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
measure: Changes in the digit span test to assess cognitive impairments
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
measure: Changes in the Posttraumatic stress disorder checklist scale (PCLS) to assess cognitive impairments
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
measure: Changes in the Hospital anxiety and depression scale (HAD scale)
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Bicêtre Hospital
Study officials:
affiliation: APHP
name: Bernard VIGUE
role: PRINCIPAL_INVESTIGATOR
References: