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

Traumatic Brain Injuries Clinical Trial

— TC-Mouv  

Official title:

Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury : a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094999
• Other study ID #: 2020-A02583-36
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: September 20, 2024

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bernard VIGUE
• Phone: 0033145216310
• Email: bernard.vigue[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. "

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 20, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injuries
• Wounds and Injuries

Intervention

Device:
• Proprioceptive stimulations
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.
• Sham stimulations
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.

Locations

Country	Name	City	State
France	Bicêtre Hospital	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Changes in the visual analog scale for the auto-assessment of problematic spasticity	Score range from 0 to 100, higher values represent a higher degree 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.
Secondary	Changes in the visual analog scale for the auto-assessment of problematic spasticity	Score range from 0 to 100, higher values represent a higher degree 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
Secondary	Changes in the Coma recovery scale-revised (CRS-R)	This measure enables to assess coma recovery (Score range from 0 to 23, higher values represent a better outcome)	At inclusion, and at one month, 2 months and 1 year after the injury.
Secondary	Changes in the Glasgow outcome scale (GOS)	This measure enables to assess coma recovery (Score range from 0 to 5, higher values represent a better outcome)	At inclusion, and at one month, 2 months and 1 year after the injury.
Secondary	Changes in the Glasgow outcome scale-extended (GOS-E)	This measure enables to assess coma recovery (Score range from 0 to 8, higher values represent a better outcome)	At inclusion, and at one month, 2 months and 1 year after the injury.
Secondary	Changes in the Disability rating scale (DRS)	This measure enables to assess coma recovery (Score range from 0 to 29, lower values represent a better outcome)	At inclusion, and at one month, 2 months and 1 year after the injury.
Secondary	Changes in the quadriceps muscle thickness	"Measured with ultrasound, average of two measures (at the border between the lower third and upper two-thirds between the anterior superior iliac spine and the upper pole of the patella, and at the midpoint between the anterior superior iliac spine and the upper pole of the patella) (Measure in centimeters, higher values represent a better outcome)"	At inclusion, then once a week during the first month, and at 2 months, 6 months and 1 year after the injury
Secondary	Changes in the Montreal cognitive assessment (MoCA)	This measure enables to assess cognitive impairments (Score range from 0 to 30, higher values represent a better outcome)	Up to 1 month, then at 2 months and 1 year after the injury
Secondary	Changes in the time to complete the bells cancellation test to assess cognitive impairments	This measure enables to assess cognitive impairments (Measure in minutes and seconds, lower values represent a better outcome)	Up to 1 month, then at 2 months and 1 year after the injury
Secondary	Changes in the digit span test to assess cognitive impairments	This measure enables to assess cognitive impairments (Higher values represent a better outcome)	Up to 1 month, then at 2 months and 1 year after the injury
Secondary	Changes in the Posttraumatic stress disorder checklist scale (PCLS) to assess cognitive impairments	This measure enables to assess cognitive impairments (Score range from 17 to 85, lower values represent a better outcome)	Up to 1 month, then at 2 months and 1 year after the injury
Secondary	Changes in the Hospital anxiety and depression scale (HAD scale)	This measure enables to assess cognitive impairments (Score range from 0 to 42, lower values represent a better outcome)	Up to 1 month, then at 2 months and 1 year after the injury