Neural mechanisms of movement, balance and spatial orientation in health and disease
ISRCTN | ISRCTN16535836 |
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DOI | https://doi.org/10.1186/ISRCTN16535836 |
Secondary identifying numbers | 1 |
- Submission date
- 13/10/2016
- Registration date
- 19/01/2017
- Last edited
- 21/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
The brain is responsible for controlling balance and orientation in the space around us (spatial orientation). This function allows us to effortlessly walk in busy environments such as a crowded pavement or even to get out of bed at night and walk around in the dark. To achieve such effortless balance, the brain uses information from the vestibular (balance system) and auditory (system for the sense of hearing ) systems in the inner ear, joint and muscle sensors (that help to control limb movement) and what we see. The brain also uses information from previous experience, such as using memories of the layout of the furniture in a room to navigate when we are unable to see in darkness. This study aims to assess how the brain combines these different signals to help our balance in health and disease.
Who can participate?
Adults with brain injury affecting brain functioning and healthy adults of the same age.
What does the study involve?
Participants are invited to attend three hospital appointments over the course of the study, spaced two-three months apart. At each appointment, participants will be assessed by a doctor to check for any changes in health status such as migraine or new onset dizziness. At the visit, participants may undergo an MRI scan, in order to assess how well the central nervous system (the brain and spinal cord) is functioning. In addition, participants complete a number of clinical and behavioural testing that assess the basic mechanisms of nervous functioning that may affect balance (these tests typically occur while seated and include testing of the functioning - and their brain connections - of the inner ear balance and hearing organs, the eye and limb muscles). Finally, patients undergo formal tests of balance which will take place when standing or walking (for safety, patients are either harnessed or accompanied by a researcher). These tests are then repeated three and six months later.
What are the possible benefits and risks of participating?
There are no direct benefits of participating, although the results will provide valuable information for the future development of effective therapies for patients suffering with imbalance and spatial disorientation. There are no notable risks involved with participating.
Where is the study run from?
1. Charing Cross Hospital (UK)
2. St Mary’s Hospital (UK)
3. Hammersmith Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2017 to March 2021
Who is funding the study?
1. Medical Research Council (UK)
2. Imperial College Healthcare Charity (UK)
Who is the main contact?
1. Dr Barry Seemungal (scientific)
b.seemungal@imperial.ac.uk
2. Dr Elena Calzolari (public)
e.calzolari@imperial.ac.uk
Contact information
Scientific
Room 10L14
Charing Cross Hospital
London
W6 8RF
United Kingdom
0000-0002-6578-0904 |
Public
10th floor Lab Block
Charing Cross Hospital
London
W6 8RF
United Kingdom
Phone | +44 20 331 17042 |
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e.calzolari@imperial.ac.uk |
Study information
Study design | Observational prospective case-control study |
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Primary study design | Observational |
Secondary study design | Case-control study |
Study setting(s) | Hospital |
Study type | Other |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | An observational study of the mechanisms contributing to recovery in imbalance and spatial disorientation following injury to the nervous system |
Study objectives | Study aims: 1. To investigate how movement, balance and orientation are impaired in conditions that affect the functioning of the brain 2. To help provide a mechanistic explanation for the future development of therapy in neurological patients with impaired balance and spatial orientation Hypothesis: Brain networks coordinate human balance function, and disruption of these networks from disease is important in impairing balance and spatial orientation in humans. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Balance, dizziness and spatial disorientation |
Intervention | 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 an hour. A series of behavioural and neurophysiological tests (i.e. non-invasive measures of the body’s and brain’s electrical activity and excitability) are also performed either whilst seated or lying down, to assess functions that can affect balance and spatial orientation performance. The tasks include visual, vestibular and auditory stimuli which may require verbal or button press responses. Balance performance will be objectively measured through assessment of body motion during standing and walking tasks. For safety, patients will be tethered or accompanied by a researcher for the standing and walking tests. This testing session will take half a day. Follow-up will take place at three and six months. |
Intervention type | Other |
Primary outcome measure | 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 outcome measures | 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 |
Overall study start date | 01/01/2017 |
Completion date | 01/03/2021 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Both |
Target number of participants | 225 (includes patients and controls) |
Key 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 |
Key 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 |
Date of first enrolment | 01/03/2017 |
Date of final enrolment | 01/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
W6 8RF
United Kingdom
London
W2 1NY
United Kingdom
London
W12 0HS
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Compliance Office
Room 21
Medical School
St Mary's Campus
London
W2 1NY
England
United Kingdom
Website | http://www.imperial.nhs.uk/ |
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https://ror.org/056ffv270 |
University/education
Joint Research Compliance Office
Room 215
Medical School
St Mary's Campus
London
W2 1NY
England
United Kingdom
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
No information available
Results and Publications
Intention to publish date | 01/06/2021 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Publications in peer reviewed journals - open access. |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from barseem@gmail.com. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Other publications | 14/10/2022 | 21/09/2023 | Yes | No | |
Results article | 15/12/2022 | 21/09/2023 | Yes | No | |
Results article | 01/01/2021 | 21/09/2023 | Yes | No |
Editorial Notes
21/09/2023: Publication references added.
09/02/2017: Internal review.