Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury (TC-Mouv)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Traumatic Brain Injuries

Treatments: Device: Proprioceptive stimulations; Device: Sham stimulations

Study type: Interventional

Funder types: Other

Identifiers

NCT05094999

2020-A02583-36

Details and patient eligibility

About

"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. "

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Intervention group

Experimental group

Description:

Vibration treatment will last eight weeks for each patient, with 4 sessions per week, 30 minutes per session. Subjects of the intervention group will receive proprioceptive stimulations set to create illusions of movement.

Treatment:

Device: Proprioceptive stimulations

Control group

Sham Comparator group

Description:

Vibration treatment will last eight weeks for each patient, with 4 sessions per week, 30 minutes per session. Subjects of the control group will receive sham stimulations.

Treatment:

Device: Sham stimulations