Dizziness due to visual stimuli in patients with concussion and other causes of dizziness: Investigation of balance behavior.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Visually induced dizziness in patients after concussion and non-traumatic dizziness.
(BASEC)
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)
Critères d'exclusion
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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Universität Zürich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Dominik Straumann
+41 44 255 55 64
dominik.straumann@clutteruzh.chMedizinische Fakultät Universität Zürich Rämistrasse 71, 8006 Zürich
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
13.05.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06893029 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Visually Induced Dizziness in Concussed and Non-Concussed Dizzy Patients: Identifying the Pathophysiology of Postural Control Upon Optokinetic Stimuli (BASEC)
Titre académique
Visually Induced Dizziness in Concussed and Non-Concussed Dizzy Patients: Identifying the Pathophysiology of Postural Control Upon Optokinetic Stimuli (ICTRP)
Titre public
Dizziness Due to Visual Stimuli in Patients With Concussion and Other Causes of Dizziness: Examination of Balance Behaviour (ICTRP)
Maladie en cours d'investigation
DizzinessConcussion (Diagnosis)Traumatic Brain InjuryBalance Assessment (ICTRP)
Intervention étudiée
Diagnostic Test: Postural Response upon physical optokinetic stimulationDiagnostic Test: Postural Response upon virtual optokinetic stimulation (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Single (Participant). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Sensitivity of Postural Response to Optokinetic Stimulation (ICTRP)
Identification of Different Postural Characteristics Response to Optokinetic Stimulation;Severity of Visually Induced Dizziness (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
University Hospital, Z�rich;BrainCare Medical Group (ICTRP)
Contacts supplémentaires
Dominik Straumann, Prof. Dr. med., Dominik.Straumann@uzh.ch, +41 44 255 55 64 (ICTRP)
ID secondaires
2024-00956 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06893029 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible