A study to demonstrate the ability of the EMTensor brain-imaging scanner to identify and distinguish different acute brain damage in patients with brain disorders

Not Applicable

• Conditions: eurological disorders; Nervous System Diseases

• Registration Number: ISRCTN18134070
• Lead Sponsor: EMTensor GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 10 December 2019
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged 18 or above
2. Within one week of hospital admission with an acute neurological condition, with an intracranial pathology identified on the CT or MRI head scan (e.g. ischemic stroke, intracerebral hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, brain tumors, cerebral edema)
3. Within 1-2 hours after baseline CT/MRI-scan.
4. Informed consent by the patient or by their legal representative

Exclusion Criteria

1. Pregnancy (as determined by a positive urine pregnancy-test scheduled before the EMT-scan) or lactating females
2. Physically unable to comply with study procedures
3. Known hypersensitivity to latex
4. Patients with pacemakers or electronic defibrillators
5. Metal or metal-like implant located in head or neck-area - also ceramic implants and programmable shunts are excluded
6. Open wounds in the arear of the head and neck covered by the EMT-device
7. Participation in another clinical trial that would confound study results

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of neuropathology identified by abnormal signal on the EMT-scan

Secondary Outcome Measures

Name	Time	Method
<br> 1. Assessing the feasibility of the use of the EMT-scanner in imaging for stroke by expert comparison to standard care scans like MRI or CT-scan as baseline examinations.<br> 2. The number of participants who complete the scan according to the protocol<br> 3. The proportion of images determined to be of adequate quality for interpretation as determined by experts (Prof. Roffe and colleagues).<br> 4. Incidence of all Serious Adverse Events recorded by questionnaire according to protocol at the latest 48 hours after the scan.<br>