Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury

NCT05094999 | Unknown

• 1 other identifier: 2020-A02583-36
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. "

Conditions

Traumatic Brain Injuries

Keywords

traumatic brain injuries; proprioceptive stimulation; vibration; spasticity; intensive care units

Outcome Measures

Primary Outcomes (4)

• Changes in the modified Ashworth scale (MAS)

  The MAS enables to assess spasticity. The muscle whose spasticity will be assessed are the soleus, gastrocnemius, knee extensors, knee flexors, adductors and gracilis (Score range from 0 to 5 per muscle, higher values represent a higher severity of spasticity) adductors and gracilis

  Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.

• Changes in the angles of the muscle reaction in the modified Tardieu scale (MTS)

  The MTS enables to assess the severity of spasticity. The muscle whose spasticity will be assessed are the soleus, gastrocnemius, knee extensors, knee flexors, adductors and gracilis (The outcome is reported in degree, from 0 to 180 degrees, higher values represent a higher dynamic component of spasticity)

  Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.

• Changes in the quality of the muscle reaction in the modified Tardieu scale (MTS)

  The muscle whose spasticity will be assessed are the soleus, gastrocnemius, knee extensors, knee flexors, adductors and gracilis (Score range from 0 to 5 per muscle, higher values represent a higher severity of spasticity)

  Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.

• Changes in the Spinal cord assessment tool for spastic reflexes (SCATS)

  This score enables to asses global spasticity (Score range from 0 to 18, higher values represent a higher degree of spasticity)

  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 (12)

• Changes in the visual analog scale for the auto-assessment of problematic spasticity

  Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.

• Changes in the visual analog scale for the auto-assessment of problematic spasticity

  Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury

• Changes in the Coma recovery scale-revised (CRS-R)

  At inclusion, and at one month, 2 months and 1 year after the injury.

• Changes in the Glasgow outcome scale (GOS)

  At inclusion, and at one month, 2 months and 1 year after the injury.

• Changes in the Glasgow outcome scale-extended (GOS-E)

  At inclusion, and at one month, 2 months and 1 year after the injury.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: Proprioceptive stimulations

Control group

SHAM COMPARATOR

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.

Device: Sham stimulations

Interventions

Proprioceptive stimulations DEVICE

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.

Intervention group

Sham stimulations DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard VIGUE

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard VIGUE

CONTACT

0033145216310; bernard.vigue@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 27, 2021
• Study Start: October 20, 2021
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: October 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)