Can treatment with Cerebrolysin and magnetic stimulation of the brain improve recovery after traumatic brain injury?

Phase 2

Completed

• Conditions: Traumatic Brain Injury (TBI) onset 30 days prior to screening; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN10335247
• Lead Sponsor: EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37360156/ (added 31/08/2023) 2024 Results article in https://medandlife.org/wp-content/uploads/12-JML-2024-0187.pdf (added 19/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-19
• Study Completion: 2022-02-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 93

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified