A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

NeMoDevices

Status: Completed

Conditions: Subarachnoid Hemorrhage; Optical Imaging

Treatments: Device: NeMo Patch and NeMo Probe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01802762

E!6526_OPTO-BRAIN (Other Grant/Funding Number)

P-1.000_NeMo_C001 / MUG

Details and patient eligibility

About

To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult male or female patient, ≥ 18 and ≤ 75 years
2. Patient with severe SAH (GCS ≤ 12) or severe TBI (GCS ≤ 8)
3. Decreased level of consciousness with the need for ICP monitoring for an estimated duration of more than 3 days
4. Negative pre-treatment serum pregnancy test for female patients with childbearing potential
5. In patients with severe SAH or severe TBI with need for ICP monitoring an acute emergency situation exists. The inclusion follows

Exclusion criteria

1. Known kidney disease, defined as plasma creatinine > 120 µmol/l
2. Known liver disease, defined as GOT > 200U/l
3. History of allergic disorders, including allergic reactions against contrast agents containing iodine, against ICG and against plasters, as well as patients with thyroid disease causing hyperthyroidism
4. Pre-existing disability and/or legal representative
5. Participation in another interventional clinical trial within the last 30 days before start of treatment

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

NeMo Patch and NeMo Probe

Other group

Description:

TBI and SAH patients, one arm

Treatment:

Device: NeMo Patch and NeMo Probe