Brain Injuries, Traumatic Clinical Trial
— MBI01Official title:
Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers: A Prospective Study Evaluating Ability of Microwave Scanning in Conjunction With Biomarkers to Diagnose Traumatic Intracranial Hemorrhage
This study will evaluate if traumatic intracranial hemorrhage can be safely ruled out by using a microwave scanner (MD100) in conjunction with a combination of different brain biomarkers analyzed in serum.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | January 12, 2026 |
Est. primary completion date | January 10, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria (groups A and B): - Verbal Informed Consent in the acute phase. - Signed Informed Consent Form after the acute phase. On behalf of the patient, independent witness signed informed consent (in cases where the patient is unable to sign). - Acute trauma patient with suspected head injury - Time from injury to measurement procedure not longer than 8 hours 15 min - Head CT prescribed by treating physician - Patient is = 18 years of age - Patient is deemed clinically stable Exclusion Criteria (groups A and B): - Patient has suspected cervical spine fracture, per the Investigator's judgement - Patient has by CT confirmed cervical spine fracture - Patient has confirmed skull fracture with risk for dislocation. - Patient has a shunt or other foreign object implanted intracranially (if known by medical records) - Patient has agraffes or other metal parts, thick bandage (>1cm), or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure. - Patient diagnosed with a condition associated with risk of poor protocol compliance - The measurement procedure is deemed to interfere with the standard of care - Other condition or symptoms preventing the patient from entering the trial, per the investigator´s judgment Inclusion Criteria (Group C): - Patient is = 18 years of age - Signed informed consent Exclusion Criteria (Group C): • Previous stroke or other diagnosed and/or treated brain injury |
Country | Name | City | State |
---|---|---|---|
Sweden | Helsingborg General Hospital | Helsingborg | Skåne |
Lead Sponsor | Collaborator |
---|---|
Region Skane | Medfield Diagnostics |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability to detect intracranial hemorrhage | The ability of the device MD100, with and without brain biomarkers (Aß40, Aß42, GFAP, H-FABP, S100B, NF-L, NSE, UCH-L1 and IL-10) to detect traumatic intracranial haemorrhage, as measured by the area under the receiver operating characteristics curve. | 3.5 years | |
Secondary | Estimating anatomic position of intracranial hemorrhage | The accuracy for estimating the position of intracranial hemorrhage with microwave data. | 3.5 years | |
Secondary | Estimating volume of intracranial hemorrhage | The accuracy for estimating the volume of intracranial hemorrhage with microwave data. | 3.5 years | |
Secondary | Adverse events of microwave scan | Any adverse events occurring within 24 hours of microwave scan | 3.5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04111549 -
GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth
|
N/A | |
Recruiting |
NCT05097261 -
Ketamine in Acute Brain Injury Patients.
|
Phase 4 | |
Completed |
NCT03504709 -
REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
|
||
Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
Completed |
NCT05057377 -
Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
|
||
Withdrawn |
NCT02776488 -
Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)
|
Phase 2 | |
Completed |
NCT02426749 -
Treatment and Recovery Monitoring of Post TBI Symptoms
|
N/A | |
Completed |
NCT01339702 -
The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
|
||
Recruiting |
NCT05977270 -
The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury
|
N/A | |
Active, not recruiting |
NCT04559724 -
Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes
|
N/A | |
Not yet recruiting |
NCT04515420 -
The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
|
||
Not yet recruiting |
NCT05569993 -
Glutamine and Traumatic Brain Injury
|
Early Phase 1 | |
Recruiting |
NCT04331392 -
Online Memory Intervention for Individuals With Traumatic Brain Injury
|
N/A | |
Completed |
NCT03727737 -
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI
|
N/A | |
Completed |
NCT03153397 -
Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
|
N/A | |
Completed |
NCT01336413 -
Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans
|
Phase 2 | |
Completed |
NCT02004080 -
CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
|
||
Completed |
NCT04957563 -
Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia
|
N/A | |
Completed |
NCT05179330 -
Visual Feedback in Lower Limb Rehabilitation
|
N/A | |
Completed |
NCT05397704 -
Brain Oximeter Calibration and Validation Study
|
N/A |