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Charles Bonnet SyndromeNCT04777630

Neuroscience of Charles Bonnet Syndrome

An observational study of Charles Bonnet Syndrome, run by University of Oxford at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Charles Bonnet Syndrome (CBS) is a condition in which people experience complex visual hallucinations, such as 'Acrobats balancing on bicycles' or 'Spiders crossing meals'. The condition usually occurs in people who have significant vision loss due to eye disease. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Charles Bonnet Syndrome
What is being tested?
None, neuroimaging
How many people
16 participants
Where
2 sitesUnited Kingdom
Study dates
1 Sep 2021to 20 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: There will be two cohorts of participants. Cohort one will consist of low vision (as defined clinically) patients who experience visual hallucinations and cohort two will consist of low vision patients who do not experience visual hallucinations. Male and female adults will be included.

Who may be able to join

  • Participant is willing \& able to give informed consent for participation in the study.
  • Male or female, aged 18 - 70 years.
  • Reduced vision.

Who cannot join

  • Pre-existing amblyopia or squint.
  • Insufficient understanding of written and verbal English to complete safety screening questionnaires.
  • Pregnancy or trying to conceive.
  • Other neurological problems which may confound the results, e.g. diagnosis of Parkinsons.
  • Contraindication to MRI e.g. claustrophobia, presence of metallic implants, a pacemaker, recent surgery etc.
  • MR Spectroscopy contraindications e.g. use of antidepressants or antipsychotic medication, frequent cigarette and alcohol consumption. This is defined as no more than one cigarette per day within the past 3 months, and no alcohol use within 3 days prior to scanning.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Vision and Eye Research Institute

    Cambridge

  • Wellcome Centre for Integrative Neuroimaging

    Oxford, OX3 9DU

Other trials in United Kingdom

About this study

Official title: The Neurochemistry and Connectivity in the Brain in Charles Bonnet Syndrome

Charles Bonnet Syndrome (CBS) is a condition in which people experience complex visual hallucinations, such as 'Acrobats balancing on bicycles' or 'Spiders crossing meals'. The condition usually occurs in people who have significant vision loss due to eye disease. The aim of this project is to help understand how these hallucinations come about.

In the healthy visual system, the eye provides input to a large area of the brain that performs the computations required to allow us to see the world. There are specialised brain regions responsible for processing of faces, objects, motion and colour. When the eye is no longer working, these parts of the brain lose their input and this may lead to abnormal activity.

Read more

Not all people with eye disease and vision loss develop CBS, so the investigators will use magnetic resonance imaging (MRI) to compare the brains of people with and without the condition. In particular the investigators are interested in measuring the levels of chemicals in the visual areas of the brain to see whether they are disrupted in CBS, leading to the hallucinations. It is possible to measure how the different areas of the visual brain are connected together and see whether this is altered in CBS, perhaps with increases in the strength of connection between specialised areas. These measures will be related to questionnaires about hallucinations and vision. This will be done by comparing low vision who experience Charles Bonnet visual hallucinations compared to low vision patients who do not have hallucinations. Assessments will take place at the Wellcome Centre for Integrative Imaging (WIN) based at the John Radcliffe Hospital.

The study will provide insight into the role of the brain in generating CBS hallucinations, helping us to design a larger study and eventually to test whether there are interventions to help improve the condition.

Read the detailed description

Charles Bonnet Syndrome (CBS) has been reported in people with visual impairment, and is surprisingly common with an estimated prevalence of 10-34% of low vision patients from local audits. It consists of complex visual hallucinations such as seeing snakes rising from people's heads or elephants inside a room (see review, Carpenter, Jolly et al. 2019). Patients experience CBS hallucinations over many years, and although they retain knowledge it is not real, the hallucinations can be frightening and cause considerable distress. Patients with CBS have a lower quality of life compared to patients with vision loss without CBS. Moreover, CBS is under reported due to the fear of being labelled with mental health disease, adding to the negative consequences.

There is currently no established treatment for CBS, with the mainstay of management in low vision clinics revolving around reassurance. Many patients receive inappropriate care from other healthcare practitioners as reported by Judith Potts, founder of Esme's Umbrella, a patient support charity dedicated to Charles Bonnet Syndrome. A clearer understanding of the mechanisms underlying CBS would help to ensure the medical community takes the condition seriously and therefore adequately counsel presenting patients. In addition, understanding the neural mechanisms of CBS can provide a model for investigating how the brain reorganizes in response to sensory impairment and may eventually lead to improvement in the management and treatment of the neurological consequences of eye disease.

Visual processing becomes more complex throughout the pathway from the retina, primary visual cortex to the more specialised processing in higher visual areas. Thus, the complex nature of the hallucinations in CBS (faces, objects, animals), in spite of blurred vision, appears to implicate the higher visual areas in the visual ventral stream that are known to be process objects.

Neurotransmitters are the chemicals that allow communication across the brain. Some neurotransmitters increase the activity in the brain (excitatory) and others reduce activity (inhibitory). A candidate mechanism for CBS from computational modelling is the imbalance of excitation:inhibition: loss of feedforward visual input may give greater prominence to feedback in higher visual areas, causing hallucinations. A recent EEG study has provided experimental support, showing that hyperexcitability of the visual cortex was a key difference between people who have hallucinations versus those who do not. A critical proof of this theory would require measurement of excitatory and inhibitory neurochemicals, glutamate and GABA respectively, in visual areas. This is still outstanding and will be tackled by this study. MRS-imaging is a cutting-edge method to quantify the concentration of neurochemicals in the brain. Rather than providing a single measurement from a large volume of tissue (30x30x30mm), this technique provides high spatial resolution (5x5x20mm) measurements that permits comparison across the visual cortex. MRSI is the only technique that can non-invasively quantify neurochemicals in the living human brain, and MRS-imaging can provide concentrations of the neurotransmitters in multiple locations, which can then be compared across groups.

In summary, based on previous work and the nature of the hallucinations, the investigators predict that patients with CBS likely show 1) changes in the neurotransmitter balance across the visual cortex; 2) increased influence of feedback mechanisms from higher visual areas and 3) abnormal activity in the ventral visual stream to visual stimulation. Our goal is to characterise the visual cortex of CBS patients by using rigorous non-invasive multi-modal MR imaging techniques. Using state-of-the-art methods, the team will measure concentrations of excitatory and inhibitory neurotransmitters, identify changes in connectivity, and measure evoked visual activity in patients with CBS and visually impaired participants without CBS. In addition, the team will obtain clinical evaluation and qualitative assessments of hallucinations.

Being tested
None, neuroimaging
Keywords
charles bonnet, visual brain, hallucinations, low vision
Medical subject headings
Charles Bonnet Syndrome, Hallucinations, Vision, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None, neuroimagingDiagnostic test

    Observation only to observe differences in neuroimaging

Study groups in NCT04777630
Study groupRoleWhat they receive
Patients with low vision who experience Charles Bonnet hallucinationsNo intervention, observation of neuroimaging and questionnaires
Receives: Diagnostic Test: None, neuroimaging
Patients with low vision who do not experience Charles Bonnet hallucinationsNo intervention, observation of neuroimaging and questionnaires
Receives: Diagnostic Test: None, neuroimaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess changes in neurotransmitter balance across the visual cortex in patients with hallucinations compared to without hallucinations using MRSI.

    Comparison of neurotransmitter concentrations in different areas of the visual cortex. Correlation of these with the results of the questionnaires about hallucinations.

    Measured: 1 day

Secondary outcomes (2)
  1. To characterise the connectivity of visual areas across the brain in patients with hallucinations compared to without hallucinations (resting state and diffusion MRI).

    Connectivity between visual centres (resting state MRI) and microstructural properties of the white matter from diffusion MRI (FA and MD).

    Measured: 1 day

  2. To assess functional changes in the ventral visual stream in patients with hallucinations compared to without hallucinations (functional MRI).

    Difference in Blood oxygenation level dependent (BOLD) response to simple and complex stimuli.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2021
  2. Study start1 Sep 2021
  3. Primary completion20 Dec 2023
  4. Study completion20 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04777630
Sponsor's protocol ID
PID15262
Other IDs
IRAS No: 290078
Status last verified
May 2024
First submitted
17 Feb 2021
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Charles Bonnet Syndrome, run by University of Oxford at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess changes in neurotransmitter balance across the visual cortex in patients with hallucinations compared to without hallucinations using MRSI. (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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