Informazioni generali
  • Categoria della malattia Malattie cerebrali (non cancro) , Lesione / ferita , Malattie del sistema nervoso , Altro (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Zurigo
    (BASEC)
  • Responsabile dello studio Prof. Dr. med. Dominik Straumann dominik.straumann@uzh.ch (BASEC)
  • Fonte dati BASEC: Importato da 13.05.2025 ICTRP: Importato da 13.06.2025
  • Ultimo aggiornamento 13.06.2025 02:00
HumRes66886 | SNCTP000006406 | BASEC2024-00956 | NCT06893029

Dizziness due to visual stimuli in patients with concussion and other causes of dizziness: Investigation of balance behavior.

  • Categoria della malattia Malattie cerebrali (non cancro) , Lesione / ferita , Malattie del sistema nervoso , Altro (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Zurigo
    (BASEC)
  • Responsabile dello studio Prof. Dr. med. Dominik Straumann dominik.straumann@uzh.ch (BASEC)
  • Fonte dati BASEC: Importato da 13.05.2025 ICTRP: Importato da 13.06.2025
  • Ultimo aggiornamento 13.06.2025 02:00

Descrizione riassuntiva dello studio

This research project aims to quantify balance behavior under specific visual stimulation. Dizziness triggered by such complex visual patterns, also known as optokinetic stimulation, is referred to in this context as visually induced dizziness. The study will investigate patients with persistent symptoms following a concussion or non-traumatic dizziness. Healthy participants will serve as the control group. The optokinetic stimulation will be conducted using a physical turntable or virtual reality headset. The visual stimuli will be generated by bright points. During the stimulation, the patterns will move in different directions, and simultaneously, balance will be recorded. Additionally, the symptoms produced, such as dizziness, headache, or nausea, will be documented. The goal of this project is to improve objective diagnostic procedures for patients with visually induced dizziness. By comparing patients and healthy participants, a classification of the severity of the disorder will be enabled. It is also assumed that the sensitivity of the investigation can be enhanced by applying various optokinetic stimuli during the balance assessment. In the long term, reliable and objective diagnostics will support targeted treatment and management of VID patients.

(BASEC)

Intervento studiato

A balance assessment will be conducted with patients and healthy participants. The stimulation involves visual, optokinetic stimuli that may influence balance behavior. Additionally, dizziness symptoms may be triggered by the stimulation.

(BASEC)

Malattie studiate

Visually induced dizziness in patients after concussion and non-traumatic dizziness.

(BASEC)

Criteri di partecipazione
The inclusion criteria for healthy participants are as follows: (1) Age between 18 and 60 years, (2) vision with both eyes, and (3) no concussion/mTBI, diagnosis related to dizziness (including vestibular migraine) or VID in the last 18 months, (4) no medical history of neurological disorders, psychiatric conditions, or other chronic health issues that could affect the study results, and (5) signed consent form. The inclusion criteria for patients are as follows: (1) Age between 18 and 60 years, (2) vision with both eyes, and (3) recent concussion/mTBI within 4 weeks to 18 months after the event for patients with concussion or a diagnosis related to dizziness, vestibular migraine, or VID from 4 weeks to 18 months for dizziness patients without concussion, and (4) signed consent form. (BASEC)

Criteri di esclusione
The exclusion criteria for healthy participants are as follows: (1) BMI over 30, (2) an acute, severe dizziness lasting at least 24 hours, (3) severe, uncorrectable visual impairments, (4) balance problems not related to dizziness (e.g., neurological [e.g., migraine], orthopedic [e.g., lower extremity injury], infectious diseases, other medical conditions), (5) dizziness attributable to prescribed medications, drug use, or mental disorders, (6) cognitive impairments affecting task comprehension, (7) previous traumatic head injuries in the last 12 months, severe traumatic brain injuries with persistent impairments, (8) other potentially influencing factors (e.g., psychiatric conditions), and (9) frequent episodes of vertigo. The exclusion criteria for patients are as follows: (1) BMI over 30, (2) an acute, severe dizziness lasting at least 24 hours, (3) severe, uncorrectable visual impairments, (4) balance problems not related to dizziness (e.g., neurological [e.g., migraine], orthopedic [e.g., lower extremity injury], infectious diseases, other medical conditions), (5) dizziness attributable to prescribed medications, drug use, or mental disorders, (6) cognitive impairments affecting task comprehension, (7) previous traumatic head injuries in the last 12 months, severe traumatic brain injuries with persistent impairments, (8) other potentially influencing factors (e.g., psychiatric conditions), and (9) frequent episodes of vertigo. (BASEC)

Luogo dello studio

Zurigo

(BASEC)

Switzerland (ICTRP)

Sponsor

Universität Zürich

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Prof. Dr. med. Dominik Straumann

+41 44 255 55 64

dominik.straumann@uzh.ch

Medizinische Fakultät Universität Zürich Rämistrasse 71, 8006 Zürich

(BASEC)

Informazioni generali

+41 44 255 55 64

dominik.straumann@uzh.ch

(ICTRP)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione etica Zurigo

(BASEC)

Data di approvazione del comitato etico

13.05.2025

(BASEC)


ID di studio ICTRP
NCT06893029 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Visually Induced Dizziness in Concussed and Non-Concussed Dizzy Patients: Identifying the Pathophysiology of Postural Control Upon Optokinetic Stimuli (BASEC)

Titolo accademico
Visually Induced Dizziness in Concussed and Non-Concussed Dizzy Patients: Identifying the Pathophysiology of Postural Control Upon Optokinetic Stimuli (ICTRP)

Titolo pubblico
Dizziness Due to Visual Stimuli in Patients With Concussion and Other Causes of Dizziness: Examination of Balance Behaviour (ICTRP)

Malattie studiate
DizzinessConcussion (Diagnosis)Traumatic Brain InjuryBalance Assessment (ICTRP)

Intervento studiato
Diagnostic Test: Postural Response upon physical optokinetic stimulationDiagnostic Test: Postural Response upon virtual optokinetic stimulation (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Single (Participant). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

- Age between 18 and 60 years

- Binocular vision

- Recent concussion/mTBI within 4 weeks to 18 months post-injury for concussed
patients

- Diagnosis related to dizziness or VID within 4 weeks to 18 months for non-concussed
dizzy patients (including vestibular migraine)

- Signed ICF for included participants or signed general consent for retrospectively
included patients if an ICF cannot be obtained.

Exclusion Criteria:

- BMI greater than 30

- Acute vestibular syndrome lasting at least 24 hours

- Severe non-correctable visual impairment

- Balance issues not dizziness-related, including:

1. Neurological conditions (e.g., migraine)

2. Orthopaedic conditions (e.g., lower extremity injury)

3. Infectious diseases

4. Other medical contexts

- Dizziness attributed to prescribed drugs, substance abuse, or mental disorders

- Cognitive impairments compromising task comprehension

- Preceding history of traumatic brain injury in the last 12 months

- History of severe traumatic brain injury with persisting impairments

- Other potentially confounding problems (e.g., psychiatric disease)

- Frequent episodes of rotatory vertigo (ICTRP)

non disponibile

Endpoint primari e secondari
Sensitivity of Postural Response to Optokinetic Stimulation (ICTRP)

Identification of Different Postural Characteristics Response to Optokinetic Stimulation;Severity of Visually Induced Dizziness (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
University Hospital, Z�rich;BrainCare Medical Group (ICTRP)

Contatti aggiuntivi
Dominik Straumann, Prof. Dr. med., Dominik.Straumann@uzh.ch, +41 44 255 55 64 (ICTRP)

ID secondari
2024-00956 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06893029 (ICTRP)

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile