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Neural mechanisms of movement, balance and spatial orientation in health and disease

An observational study of the mechanisms contributing to recovery in imbalance and spatial disorientation following injury to the nervous system

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16535836
Enrollment
225
Registered
2017-01-19
Start date
2017-03-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Balance, dizziness and spatial disorientation Nervous System Diseases

Interventions

At baseline, participants attend a study visit where they undergo neuroimaging using MRI to assess the structural and functional integrity of the central nervous system. This session will take around

Sponsors

Imperial College Healthcare NHS Trust
Lead Sponsor
Imperial College London
Collaborator

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactElina Calzolari
e.calzolari@imperial.ac.uk+44 20 331 17042

Outcome results

None listed

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