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

Proof of Concept Study of the ability of the EMTensor Brain Imaging Scanner (EMT-Scanner) to identify intracranial pathologies in patients with neurological disorders

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18134070

Enrollment

Registered

2019-03-14

Start date

2019-03-01

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological disorders Nervous System Diseases

Interventions

Patients presenting with acute stroke or other intracranial pathologies (e.g. ischemic stroke, intracerebral haemorrhage, subdural haemorrhage, subarachnoid haemorrhage, brain tumours, cerebral oedema

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Presence of neuropathology identified by abnormal signal on the EMT-scan	—

Secondary

Measure	Time frame
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. 2. The number of participants who complete the scan according to the protocol 3. The proportion of images determined to be of adequate quality for interpretation as determined by experts (Prof. Roffe and colleagues). 4. Incidence of all Serious Adverse Events recorded by questionnaire according to protocol at the latest 48 hours after the scan.	—

Measure

Time frame

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. 2. The number of participants who complete the scan according to the protocol 3. The proportion of images determined to be of adequate quality for interpretation as determined by experts (Prof. Roffe and colleagues). 4. Incidence of all Serious Adverse Events recorded by questionnaire according to protocol at the latest 48 hours after the scan.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026