Traumatic Brain InjuriesTC-MouvNCT05094999
Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury
A study testing Proprioceptive stimulations in people with Traumatic Brain Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injuries
- What is being tested?
- Proprioceptive stimulations
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2021to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury
- Traumatic SCI
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bicêtre Hospital
Le Kremlin-Bicêtre, 94270
Bernard Vigué, MD PhD, 0033145216310, bernard.vigue@aphp.fr
Bernard Vigué, MD PhD
About this study
Official title: Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury : a Randomized Controlled Trial
"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
- Being tested
- Proprioceptive stimulations, Sham stimulations
- Keywords
- traumatic brain injuries, proprioceptive stimulation, vibration, spasticity, intensive care units
- Medical subject headings
- Brain Injuries, Traumatic, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive stimulationsDevice
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 stimulationsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Score range from 0 to 100, higher values represent a higher degree of problematic spasticity.
Measured: 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
Score range from 0 to 100, higher values represent a higher degree of problematic spasticity.
Measured: 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)
This measure enables to assess coma recovery (Score range from 0 to 23, higher values represent a better outcome)
Measured: At inclusion, and at one month, 2 months and 1 year after the injury.
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)
Measured: At inclusion, and at one month, 2 months and 1 year after the injury.
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)
Measured: At inclusion, and at one month, 2 months and 1 year after the injury.
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)
Measured: At inclusion, and at one month, 2 months and 1 year after the injury.
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)"
Measured: At inclusion, then once a week during the first month, and at 2 months, 6 months and 1 year after the injury
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)
Measured: Up to 1 month, then at 2 months and 1 year after the injury
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)
Measured: Up to 1 month, then at 2 months and 1 year after the injury
Changes in the digit span test to assess cognitive impairments
This measure enables to assess cognitive impairments (Higher values represent a better outcome)
Measured: Up to 1 month, then at 2 months and 1 year after the injury
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)
Measured: Up to 1 month, then at 2 months and 1 year after the injury
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)
Measured: Up to 1 month, then at 2 months and 1 year after the injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start20 Oct 2021 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard VIGUE, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094999
- Sponsor's protocol ID
- 2020-A02583-36
- Acronym
- TC-Mouv
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05094999
- Acronym / sponsor ID
- TC-Mouv / 2020-A02583-36
- Conditions
- Traumatic Brain Injuries
- Keywords
- traumatic brain injuries, proprioceptive stimulation, vibration, spasticity, intensive care units
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Oct 2021 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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. "
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Proprioceptive stimulationsVibration 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. |
| Control group | Sham comparator | Device: Sham stimulationsVibration 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury
- Traumatic SCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive stimulationsVibration 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 | Intervention group |
| Sham stimulationsVibration 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 | Control group |
Primary outcome
Changes in the modified Ashworth scale (MAS)
Time frame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
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
Changes in the angles of the muscle reaction in the modified Tardieu scale (MTS)
Time frame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
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)
Changes in the quality of the muscle reaction in the modified Tardieu scale (MTS)
Time frame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
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)
Changes in the Spinal cord assessment tool for spastic reflexes (SCATS)
Time frame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
This score enables to asses global spasticity (Score range from 0 to 18, higher values represent a higher degree of spasticity)
12 secondary outcomes
Changes in the visual analog scale for the auto-assessment of problematic spasticity
Time frame: 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
Time frame: 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)
Time frame: At inclusion, and at one month, 2 months and 1 year after the injury.
Changes in the Glasgow outcome scale (GOS)
Time frame: At inclusion, and at one month, 2 months and 1 year after the injury.
Changes in the Glasgow outcome scale-extended (GOS-E)
Time frame: At inclusion, and at one month, 2 months and 1 year after the injury.
Changes in the Disability rating scale (DRS)
Time frame: At inclusion, and at one month, 2 months and 1 year after the injury.
Changes in the quadriceps muscle thickness
Time frame: At inclusion, then once a week during the first month, and at 2 months, 6 months and 1 year after the injury
Changes in the Montreal cognitive assessment (MoCA)
Time frame: Up to 1 month, then at 2 months and 1 year after the injury
Changes in the time to complete the bells cancellation test to assess cognitive impairments
Time frame: Up to 1 month, then at 2 months and 1 year after the injury
Changes in the digit span test to assess cognitive impairments
Time frame: Up to 1 month, then at 2 months and 1 year after the injury
Changes in the Posttraumatic stress disorder checklist scale (PCLS) to assess cognitive impairments
Time frame: Up to 1 month, then at 2 months and 1 year after the injury
Changes in the Hospital anxiety and depression scale (HAD scale)
Time frame: Up to 1 month, then at 2 months and 1 year after the injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard VIGUE principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive stimulations in people with Traumatic Brain Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernard VIGUE (0033145216310, bernard.vigue@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the modified Ashworth scale (MAS) (time frame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.