Balance, dizziness and spatial disorientation Nervous System Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients 1. Injury to the brain and its sensorium (including eyes, ears, proprio-somatosenory system) from trauma, inflammation and/or disturbed vascular supply 2. Age 18-75 3. Male or Female Controls 1. Healthy individual 2. Age 18-75 3. Male or Female
Exclusion criteria
Exclusion criteria: Patients 1. Premorbid acute or chronic medical condition that might impair balance and/or spatial orientation (e.g. previous peripheral or central vestibular disturbances) 2. Premorbid active psychiatric, neurological or neuro-otological condition 3. Premorbid substance abuse Controls 1. Chronic medical condition requiring drug therapy (healthy controls with a past history of migraine in remission will be admissible) 2. Premorbid acute or chronic medical condition that might impair balance and/or spatial orientation (e.g. previous peripheral or central vestibular disturbances) 3. Premorbid active psychiatric, neurological or neuro-otological condition 4. Premorbid substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Functional independence is measured using the Functional Independence Measure (‘FIM’) score at 6 months 2. Cumulative falls over 6 months are measured monthly by reviewing patient diaries either via telephone or by email (or face-to-face during the two follow-up sessions) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Central and peripheral vestibular and ocular motor function is measured at baseline, 3 and 6 months 2. Balance is measured using the Romberg coefficient and measures of sway at baseline, 3 and 6 months 3. Neurophysiological markers of recovery are measured using evoked potential amplitudes and latencies and temporo-spatial changes in electrophysiological spectral power at baseline, 3 and 6 months 4. Imbalance and dizziness symptoms are measured using the DHI (dizziness handicap inventory) at baseline, 3 and 6 months 5. Migraine features are measured using IHS criteria (International Headache Society criteria) at baseline, 3 and 6 months 6. Anxiety is measured using the Generalized Anxiety Questionnaire (GAD-7) at baseline, 3 and 6 months 7. Depression is measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3 and 6 months 8. Cognitive function is measured using the Montreal Cognitive assessment, the Mesulam's Cancellation Test, the Line Bisection Test and the Trail Making Test at baseline, 3 and 6 months 9. Blood markers of inflammation are measured from blood samples collected at baseline, 3 and 6 months 10. White and grey matter and whole brain functional connectivity are measured using MRI scanning at baseline, 3 and 6 months | — |
Countries
England, United Kingdom