Co-ultra PEALut Enhances Neuronal Recovery Following Moderate Traumatic Brain Injury

NCT03818451 | Unknown

• 1 other identifier: GLIA13_1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Traumatic Brain Injury

Keywords

Moderate brain trauma; Glialia; Neuroinflammation; Neuroprotection

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Outcome measure will be assessed at 180 days (T180) after trauma

Study Arms (2)

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).

Dietary Supplement: Co-ultraPEALut (Glialia)

Interventions

Co-ultraPEALut (Glialia) DIETARY_SUPPLEMENT

Co-ultraPEALut is administered to moderate traumatic brain injured patients for 180 days

Also known as: Glialia

Study Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

Department of Neurosurgery, University of Messina

Messina, 98125, Italy

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Neuroinflammatory Diseases

Interventions

co-ultraPEALut

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alfred Conti, MD, PhD; FEBNS

CONTACT

00393382131017; contia@unime.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 28, 2019
• Study Start: May 1, 2016
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

IT (1)