Non-Invasive Neurovascular Assessment of symptoms in Persistent Post-Concussion Syndrome

Non-Invasive Neurovascular Assessment of symptoms in Persistent Post-Concussion Syndrome - NINA-PPCS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035766

Enrollment

Registered

2025-08-04

Start date

2025-06-16

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

F07.2

Interventions

Group 1: Patients with PPCS up to a maximum of 6 months post-concussion Group 2: Matched Control Group (age, gender, education)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patient Cohort: • Medically diagnosed concussion within the last 12 months • Post-Concussion Syndrome with 3 typical symptoms (e.g. headaches, dizziness, fatigue, irritability, sleep disturbances, sensitivity to light/sound, memory/concentration problems) • Age 18 – 65 years • Willingness to participate and comply with study protocols Healthy Controls: • Age 18 – 65 years • No prior diagnosed concussion • Willingness to participate and comply with study protocols

Exclusion criteria

Exclusion criteria: Patients and study participants: • Relevant cerebrovascular diseases (including myocardial infarction, heart failure) • Cerebrovascular stenosis • Lack of consent capacity

Design outcomes

Primary

Measure	Time frame
Breath Holding Index measured using transcranial Doppler sonographic assessment of cerebral blood flow velocity during hyperventilation and breath-holding	—

Secondary

Measure	Time frame
i. Symptom Severity (Total Score of the Clinical Profile Screen and Subscores for the Domains Migraine, Vestibular, Ocular, Cognition, Anxiety) ii. Total Score and Subscores in Neuropsychological Testing (PAL-5, FAS Test, VLMT, d2-R, Trail Making Test, Letter-Number Sequencing, Rey–Osterrieth Complex Figure Test, and BDI-II) iii. Impairment due to Headaches, Fatigue, Dizziness, or Sleep Disturbances assessed using the Headache Impact Test-6 (HIT-6), Multidimensional Fatigue Inventory (MFI), Dizziness Handicap Inventory (DHI), and Insomnia Severity Index (ISI) iv. Total Score of the Modified Balance Error System Score (mBESS) v. Total Score of the Vestibular Ocular Motor Screen (VOMS) vi. Distance of Near Point of Fixation vii. Heart Rate Variability	—

Measure

Time frame

i. Symptom Severity (Total Score of the Clinical Profile Screen and Subscores for the Domains Migraine, Vestibular, Ocular, Cognition, Anxiety) ii. Total Score and Subscores in Neuropsychological Testing (PAL-5, FAS Test, VLMT, d2-R, Trail Making Test, Letter-Number Sequencing, Rey–Osterrieth Complex Figure Test, and BDI-II) iii. Impairment due to Headaches, Fatigue, Dizziness, or Sleep Disturbances assessed using the Headache Impact Test-6 (HIT-6), Multidimensional Fatigue Inventory (MFI), Dizziness Handicap Inventory (DHI), and Insomnia Severity Index (ISI) iv. Total Score of the Modified Balance Error System Score (mBESS) v. Total Score of the Vestibular Ocular Motor Screen (VOMS) vi. Distance of Near Point of Fixation vii. Heart Rate Variability

—

Countries

Germany

Contacts

Public ContactMaria Rueger

Klinik für Neurologie Uniklinik Köln

maria.rueger@uk-koeln.de+4922147887803

Outcome results

None listed

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