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Unknown OBSERVATIONAL NCT03009656

Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists? (HOGAN)

Sponsor: Insel Gruppe AG, University Hospital Bern

Updated 11 times since 2017 Last updated: Jul 4, 2019 Started: Jan 10, 2017 Primary completion: Dec 31, 2020 Completion: Dec 31, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03009656, this observational or N/A phase trial focuses on Diagnostic Self Evaluation and Emergencies and remains ongoing. Sponsored by Insel Gruppe AG, University Hospital Bern, it has been updated 11 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Background: The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. Management of acute stroke patients is a main interest of the neurovascular research group at Inselspital Bern. For example, the investigators analysed the prediction of large vessel occlusion in acute stroke patients by clinical examination and found a significant association of stroke severity measured with the NIHSS score and location of vessel occlusion. Analysis of outcome in stroke patients with mild and rapidly improving symptoms demonstrated that three of four of these patients had a favourable outcome, but those with a central vessel occlusion were likely to deteriorate...

Background:

The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. Management of acute stroke patients is a main interest of the neurovascular research group at Inselspital Bern. For example, the investigators analysed the prediction of large vessel occlusion in acute stroke patients by clinical examination and found a significant association of stroke severity measured with the NIHSS score and location of vessel occlusion. Analysis of outcome in stroke patients with mild and rapidly improving symptoms demonstrated that three of four of these patients had a favourable outcome, but those with a central vessel occlusion were likely to deteriorate with poor outcome. These studies showed that there is a correlation of clinical symptoms with the mechanism of stroke, which is important for the outcome after treatment. Importantly, however, the quality of clinical assessment itself is likely highly variable, for example depending on the experience of the treating physician. Factors influencing this clinical assessment, which needs to be done under high temporal and emotional pressure in the emergency setting have not been investigated so far but might be crucial for rapid and successful treatment ("time is brain").In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.

Rationale:

By assessing whether prediction of aetiology of acute neurological deficits is experience-based the investigators aim to understand what symptoms/signs impede the in-experienced from swiftly making the correct diagnosis in the emergency setting. This should help to improve resident training and with this treatment of patients with acute neurological deficits.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotNot Yet Recruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotNot Yet Recruiting~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotNot Yet Recruiting~Nov 2018 – ~Aug 2019 · 9 months · monthly snapshotRecruiting~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotRecruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotRecruiting~Oct 2021 – ~Jul 2023 · 21 months · monthly snapshotUnknown Status~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2024 — Present [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Jul 2023 — Jul 2024 [monthly]

    Unknown Status

  5. Oct 2021 — Jul 2023 [monthly]

    Unknown Status

    Status: RecruitingUnknown Status

Show 6 earlier versions
  1. Jan 2021 — Oct 2021 [monthly]

    Recruiting

  2. Aug 2019 — Jan 2021 [monthly]

    Recruiting

  3. Nov 2018 — Aug 2019 [monthly]

    Recruiting

    Status: Not Yet RecruitingRecruiting

  4. Jun 2018 — Nov 2018 [monthly]

    Not Yet Recruiting

  5. Apr 2018 — Jun 2018 [monthly]

    Not Yet Recruiting

    Phase: NANone

  6. Jan 2017 — Apr 2018 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Insel Gruppe AG, University Hospital Bern
Data source: Insel Gruppe AG, University Hospital Bern

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations