Traumatic Brain InjuryGLIA13NCT03818451
Co-ultra PEALut Enhances Neuronal Recovery Following Moderate Traumatic Brain Injury
A study testing Co-ultraPEALut (Glialia) in people with Traumatic Brain Injury, run by University of Messina at 1 site in Italy.
Trial summary
Traumatic brain injury (TBI) typically provokes secondary injury mechanisms, including the dynamic interplay between the ischemic, inflammatory, and cytotoxic processes. Moreover, such an impact induces a substantial level of cell death and results in the degeneration of the dendrites, thereby leading to persistent… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Co-ultraPEALut (Glialia)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2016to 31 Dec 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic brain injuries
- Moderate trauma
- Glasgow Coma Score 9-13
- Loss of consciousness lasting >1 min
- post-traumatic amnesia >20 minutes
- CT scan Marshall Scale class II-VI.
Who cannot join
- Spinal cord injuries
- Pre-existing neurological disorders affecting the brain and/or the spinal cord
- Severe hypertension
- Diabetes, and chronic renal disease
- Remarkable chronic cerebravasculopathy of the CT
- Severe cognitive deficit.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, University of Messina
Messina, 98125
Alfredo Conti, MD, PhD, FEBNS, 00393382131017, contia@unime.it
About this study
Traumatic brain injury (TBI) typically provokes secondary injury mechanisms, including the dynamic interplay between the ischemic, inflammatory, and cytotoxic processes. Moreover, such an impact induces a substantial level of cell death and results in the degeneration of the dendrites, thereby leading to persistent motor, sensory, and cognitive dysfunction. Previous studies have shown that the adult-born immature granule neurons in the dentate gyrus are the most susceptible of all the cell types in the hippocampus to damage following a moderate TBI due to a controlled cortical impact (CCI) device. Currently, there is no efficient approach available for avoiding immature neuron death or degeneration following TBI. Hence, this study aimed to assess the neuro-regenerative properties of co-ultramicronized PEALut (Glialia®), which is composed of palmitoylethanolamide (PEA) and the flavonoid luteolin (Lut), in an in vivo model of TBI, as well as in patients affected by TBI.
Read the detailed description
Study Setting All patients affected by moderate TBI (Glasgow Coma Score 9-13) admitted to the neurosurgical department of the University Hospital of Messina, Italy, will be screened for recruitment.
Ethics The institutional review board (IRB) approved the study. Written consent will be obtained from each patient or the closest family member prior to the start of the study.
Study Design A randomized controlled single-blind study to assess the effects of co-ultraPEALut (Glialia®) administration in TBI patients will be carried out. The study is set to recruit at least 30 patients.
Recruited patients are randomly allocated to one of the two branches of the study: standard TBI treatment + Glialia® (Study Group) and standard TBI treatment (Control Group) in a 1:1 ratio using precompiled randomization tables.
General treatment
All patients will undergo standard treatments according to patterns of severity and in the light of distinct variables, mainly represented by the conditions of cerebral hemodynamics. These procedures can be summarized as follows:
- Surgical evacuation of hemorrhagic masses and / or "debridement" of outbreaks brain contusion;
- Medical management aimed to maintenance of euvolemia and adequate brain perfusion. Goals were a systolic blood pressure >90 mmHg and a cerebral perfusion pressure >60 mmHg. Prevention of secondary complications of critical illness included: preventive therapy of venous thromboembolism (VTE) using low molecular weight heparin (LMWH) and seizures using levetiracetam prophylactically for the first seven days after injury;
- Patient who underwent surgical treatment, received also postoperative intensive care treatments including: position of the head high, lower values of end-tidal CO2, sedation with reduced metabolic consumption of O2, increase in plasma osmolarity by administration of mannitol in controlled doses or hypernatremia, therapeutic CSF drainage.
Specific Treatment The investigations agent, the co-ultraPEALut, will be administered orally twice daily (every 12 h) for 180 days in association with the specific therapy (e.g., antiplatelet agents, anticoagulants, antiepileptic drugs) commonly administered to these patients and/or with drugs prescribed for comorbidities (i.e. diabetes, arterial hypertension).
- Conditions
- Traumatic Brain Injury
- Being tested
- Co-ultraPEALut (Glialia)
- Keywords
- Moderate brain trauma, Glialia, Neuroinflammation, Neuroprotection
- Medical subject headings
- Brain Injuries, Traumatic, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-ultraPEALut (Glialia)Dietary supplement
Also called Glialia
Co-ultraPEALut is administered to moderate traumatic brain injured patients for 180 days
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | All patients are treated by standard treatments according to patterns of severity and in the light of different variables, mainly represented by the conditions of cerebral hemodynamics. These procedures can be summarized as follows: * Surgical evacuation of hemorrhagic masses and brain contusion * Medical management aimed to maintenance of euvolemia and adequate brain perfusion. Prevention of secondary complications of critical illness included: preventive treatment of venous thromboembolism (VTE) and seizures * Patient who undergo surgical treatment, will recieve also postoperative intensive care treatments including: position of the head high, lower values of end-tidal CO2, sedation with reduced metabolic consumption of O2, increase in plasma osmolarity by administration of mannitol in controlled doses or hypernatremia, therapeutic CSF drainage |
| Study Group | Experimental | Standard treatment plus specific treatment. The investigational agent, the co-ultraPEALut, is administered orally twice daily (every 12 h) for 180 days in association with the specific therapy (e.g., antiplatelet agents, anticoagulants, antiepileptic drugs) commonly administered to these patients and/or with drugs prescribed for comorbidities (i.e. diabetes, arterial hypertension). Receives: Dietary Supplement: Co-ultraPEALut (Glialia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive outcome assessed Mini Mental State Examination (MMSE)
Impairment of cognitive abilities will be evaluated by the Mini Mental State Examination (MMSE) (Folstein et al., 1975) adjusted for educational level and age. This is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time that is within the scope of this research. The threshold value for normal performance is set to 24 points. The outcome measure will be represented by the absolute score and by the change between the score recorded after 180 days and the baseline value
Measured: All patients will undergo neurological and neuropsychological evaluations at baseline (T0), after 30 days (T30) and 6 months (T180)
Cognitive outcome assessed by the Brief Neuropsychological Cognitive Examination (BNCE)
Brief Neuropsychological Cognitive Examination (BNCE) (Ball et al., 2009). This consists in 10 subtests composed of easily administered tasks, none requiring more than minimal reading skills.Total score indicating overall severity of impairment (expressed in percentage), subtest scores, and two aggregate scores for the simple and complex subtests are provided as percentage of the maximum score. The outcome measure will be represented by the absolute score and by the difference between the score recorded after 180 days and the baseline value
Measured: All patients will undergo neurological and neuropsychological evaluations at baseline (T0), after 30 days (T30) and 6 months (T180)
Depression outcome assessed by Beck Depression Inventory
Depression will be assessed by the Beck inventory depression scale.This is a 21-question multiple-choice (scored 0-3 each) self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Scores will be categorized as follows:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression
Depression score will be assessed at 180 days (T180) after trauma
Measured: Outcome measure will be assessed at 180 days (T180) after trauma
Assessment of Independence by Barthel Index
Independence in activities of daily living and self-care will be assessed by the Barthel Index. This is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. Each domain is scored in one-point increments with a full score of 20 indicating functional independence. Independence will be assessed at 180 days (T180) after trauma
Measured: Outcome measure will be assessed at 180 days (T180) after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 May 2016
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Conti, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818451
- Sponsor's protocol ID
- GLIA13_1
- Acronym
- GLIA13
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-ultra PEALut Enhances Neuronal Recovery Following Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03818451
- Acronym / sponsor ID
- GLIA13 / GLIA13_1
- Conditions
- Traumatic Brain Injury
- Keywords
- Moderate brain trauma, Glialia, Neuroinflammation, Neuroprotection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 28 Jan 2019 (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.
Traumatic brain injury (TBI) typically provokes secondary injury mechanisms, including the dynamic interplay between the ischemic, inflammatory, and cytotoxic processes. Moreover, such an impact induces a substantial level of cell death and results in the degeneration of the dendrites, thereby leading to persistent motor, sensory, and cognitive dysfunction. Previous studies have shown that the adult-born immature granule neurons in the dentate gyrus are the most susceptible of all the cell types in the hippocampus to damage following a moderate TBI due to a controlled cortical impact (CCI) device. Currently, there is no efficient approach available for avoiding immature neuron death or degeneration following TBI. Hence, this study aimed to assess the neuro-regenerative properties of co-ultramicronized PEALut (Glialia®), which is composed of palmitoylethanolamide (PEA) and the flavonoid luteolin (Lut), in an in vivo model of TBI, as well as in patients affected by TBI.
Detailed description
Study Setting All patients affected by moderate TBI (Glasgow Coma Score 9-13) admitted to the neurosurgical department of the University Hospital of Messina, Italy, will be screened for recruitment.
Ethics The institutional review board (IRB) approved the study. Written consent will be obtained from each patient or the closest family member prior to the start of the study.
Study Design A randomized controlled single-blind study to assess the effects of co-ultraPEALut (Glialia®) administration in TBI patients will be carried out. The study is set to recruit at least 30 patients.
Recruited patients are randomly allocated to one of the two branches of the study: standard TBI treatment + Glialia® (Study Group) and standard TBI treatment (Control Group) in a 1:1 ratio using precompiled randomization tables.
General treatment
All patients will undergo standard treatments according to patterns of severity and in the light of distinct variables, mainly represented by the conditions of cerebral hemodynamics. These procedures can be summarized as follows:
- Surgical evacuation of hemorrhagic masses and / or "debridement" of outbreaks brain contusion;
- Medical management aimed to maintenance of euvolemia and adequate brain perfusion. Goals were a systolic blood pressure >90 mmHg and a cerebral perfusion pressure >60 mmHg. Prevention of secondary complications of critical illness included: preventive therapy of venous thromboembolism (VTE) using low molecular weight heparin (LMWH) and seizures using levetiracetam prophylactically for the first seven days after injury;
- Patient who underwent surgical treatment, received also postoperative intensive care treatments including: position of the head high, lower values of end-tidal CO2, sedation with reduced metabolic consumption of O2, increase in plasma osmolarity by administration of mannitol in controlled doses or hypernatremia, therapeutic CSF drainage.
Specific Treatment The investigations agent, the co-ultraPEALut, will be administered orally twice daily (every 12 h) for 180 days in association with the specific therapy (e.g., antiplatelet agents, anticoagulants, antiepileptic drugs) commonly administered to these patients and/or with drugs prescribed for comorbidities (i.e. diabetes, arterial hypertension).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –All patients are treated by standard treatments according to patterns of severity and in the light of different variables, mainly represented by the conditions of cerebral hemodynamics. These procedures can be summarized as follows: * Surgical evacuation of hemorrhagic masses and brain contusion * Medical management aimed to maintenance of euvolemia and adequate brain perfusion. Prevention of secondary complications of critical illness included: preventive treatment of venous thromboembolism (VTE) and seizures * Patient who undergo surgical treatment, will recieve also postoperative intensive care treatments including: position of the head high, lower values of end-tidal CO2, sedation with reduced metabolic consumption of O2, increase in plasma osmolarity by administration of mannitol in controlled doses or hypernatremia, therapeutic CSF drainage |
| Study Group | Experimental | Dietary Supplement: Co-ultraPEALut (Glialia)Standard treatment plus specific treatment. The investigational agent, the co-ultraPEALut, is administered orally twice daily (every 12 h) for 180 days in association with the specific therapy (e.g., antiplatelet agents, anticoagulants, antiepileptic drugs) commonly administered to these patients and/or with drugs prescribed for comorbidities (i.e. diabetes, arterial hypertension). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Traumatic brain injuries
- Moderate trauma
- Glasgow Coma Score 9-13
- Loss of consciousness lasting >1 min
- post-traumatic amnesia >20 minutes
Key exclusion criteria (6 listed)
- Spinal cord injuries
- Pre-existing neurological disorders affecting the brain and/or the spinal cord
- Severe hypertension
- Diabetes, and chronic renal disease
- Remarkable chronic cerebravasculopathy of the CT
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 |
|---|---|---|
| Co-ultraPEALut (Glialia)Also: GlialiaCo-ultraPEALut is administered to moderate traumatic brain injured patients for 180 days | Dietary supplement | Study Group |
Primary outcome
Cognitive outcome assessed Mini Mental State Examination (MMSE)
Time frame: All patients will undergo neurological and neuropsychological evaluations at baseline (T0), after 30 days (T30) and 6 months (T180)
Impairment of cognitive abilities will be evaluated by the Mini Mental State Examination (MMSE) (Folstein et al., 1975) adjusted for educational level and age. This is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time that is within the scope of this research. The threshold value for normal performance is set to 24 points. The outcome measure will be represented by the absolute score and by the change between the score recorded after 180 days and the baseline value
Cognitive outcome assessed by the Brief Neuropsychological Cognitive Examination (BNCE)
Time frame: All patients will undergo neurological and neuropsychological evaluations at baseline (T0), after 30 days (T30) and 6 months (T180)
Brief Neuropsychological Cognitive Examination (BNCE) (Ball et al., 2009). This consists in 10 subtests composed of easily administered tasks, none requiring more than minimal reading skills.Total score indicating overall severity of impairment (expressed in percentage), subtest scores, and two aggregate scores for the simple and complex subtests are provided as percentage of the maximum score. The outcome measure will be represented by the absolute score and by the difference between the score recorded after 180 days and the baseline value
Depression outcome assessed by Beck Depression Inventory
Time frame: Outcome measure will be assessed at 180 days (T180) after trauma
Depression will be assessed by the Beck inventory depression scale.This is a 21-question multiple-choice (scored 0-3 each) self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Scores will be categorized as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression Depression score will be assessed at 180 days (T180) after trauma
Assessment of Independence by Barthel Index
Time frame: Outcome measure will be assessed at 180 days (T180) after trauma
Independence in activities of daily living and self-care will be assessed by the Barthel Index. This is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. Each domain is scored in one-point increments with a full score of 20 indicating functional independence. Independence will be assessed at 180 days (T180) after trauma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-ultraPEALut (Glialia) in people with Traumatic Brain Injury, run by University of Messina at 1 site in Italy.
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 6 inclusion and 6 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 29 Jan 2019. 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 Italy. 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. 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 Alfred Conti, MD, PhD; FEBNS (00393382131017, contia@unime.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive outcome assessed Mini Mental State Examination (MMSE) (time frame: All patients will undergo neurological and neuropsychological evaluations at baseline (T0), after 30 days (T30) and 6 months (T180)). 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 29 Jan 2019.