Traumatic Brain Injury (TBI) onset 30 days prior to screening Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The synopsis of the study is organised in 3 visits:
1. Screening and Baseline - Study Day 30
2. Visit 1 - Study Day 101
3. Visit 2 - Study Day 180
No follow-up was performed after the 180-day evaluat
therefore, colored infusion lines will be used for drug administration.
Patients meeting inclusion and exclusion criteria will obtain a random number corresponding to the random list generated in adva
Sponsors
EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Traumatic brain injury onset 30 days prior to screening 2. CT/MRI – focal and/or diffuse lesions 3. Age: 18-70 years, inclusive (updated 28/02/2020: 18-80 years, inclusive) 4. Pre-Trauma Karnofsky Index 100 5. Willing and able to comply with the protocol requirements for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Metal implant in the head or within the stimulation area 2. Medical implanted devices (cardiac pacemaker, cochlea implant or medication pumps) 3. History of intracranial interventions as well as ischemic or hemorrhagic stroke 4. Evidence of pre-existing major health problems (e.g., cancer, haematological, renal, hepatic, or coronary disease, psychiatric disorder, diabetes, myocardial infarction or other known heart diseases, disabling or musculoskeletal problems like rheumatoid arthritis, epilepsy, evidence of degenerative or inflammatory diseases affecting nervous system [e.g., Alzheimer, Parkinson]). Patients with well-controlled diabetes and hypertension can be included if there is no evidence of secondary damage to major organs. 5. Any neurological or non-neurological condition independent from TBI that might influence the functional outcome or other efficacy outcome measures. 6. Injury of writing hand influencing cognitive or other outcome measures, in the investigator’s judgment. 7. Clear clinical signs of intoxication influencing the evaluation, in the investigator’s judgment. 8. Major drug dependency including alcohol, in the investigator’s judgment. 9. Chronic treatment with steroids, Ca2+-channel blockers or major anticoagulants (e.g., warfarin and other coumarin derivates), monoamine oxidase inhibitors, antipsychotic drugs or nootropic molecules. 10. Patient with penetrating brain injury. 11. Females who are pregnant or lactating. 12. Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included. A highly effective method of birth control and one which is acceptable for this study, is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive function assessed using Stroop Color-Word Test (Stroop, 1935) at days 30, 101, 180 2. Cognitive function assessed using Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) at days 30, 101, 180 3. Cognitive function assessed using PSI (Processing Speed Index, Wechsler adult intelligence scale – third edition) (Wechsler, 1997) at days 30, 101, 180 4. Cognitive function assessed using Digit Span (Wechsler adult intelligence scale – third edition) (Wechsler, 1997) at days 30, 101, 180 5. Cognitive function assessed using Trail Making Test (Reitan, 1958) at days 30, 101, 180 6. Emotional status assessed using Hamilton Anxiety Rating Scale (Hamilton, 1959) at days 30, 101, 180 7. Emotional status assessed using Hamilton Rating Scale for Depression (Hamilton, 1960) at days 30, 101, 180 8. Cognitive function assessed using One Touch Stockings of Cambridge at days 30, 101, 180 9. Cognitive function assessed using The Multitasking Test at days 30, 101, 180 10. Cognitive function assessed using Reaction Time at days 30, 101, 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Eye movements assessed using a Tobii Pro TX300 eye-tracking device and analyzed using Tobii Studio software at 30, 101 and 180 days. 2. Brain electrical activity assessed using electoencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at 30, 101 and 180 days. 3. Adverse events of magnetic stimulation of the brain recorded using a tailored safety report form based on patient self-reports during the entire duration of the trial. | — |
Countries
Romania
Contacts
Public ContactStefan Strilciuc
Outcome results
None listed