- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02905877
The Pathophysiology of Functional Neurological Disorders
Functional disorders, also called psychogenic or psychosomatic are very common, disabling and their costs to society are immense.
Functional movement disorders are abnormal, involuntary movements, that are illogical in terms of classic neurology. Intriguingly, they typically manifest when patients pay attention to them and disappear with distraction.
The investigators aim to further the understanding of the pathophysiological mechanisms underlying functional neurological disorders in order to improve treatment. In particular they aim to understand the effect of attention on movement in general, on functional neurological mechanisms and on the sense of agency (of subjective control) over a movement.
Patients with a functional neurological disorder, patients with an organic neurological disorder and healthy participants will perform simple tasks, such as reaching to a target, while additional tasks will manipulate their attention. The effects of these attentional manipulations will be analysed on several levels: movement performance, analysed by the kinematics and electromyography (EMG),and psychophysical measures, such as the sense of agency.
If the hypothesis turns out to be true, then changing the attentional focus could be used as a treatment in functional neurological disorders.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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London, United Kingdom, WC1N 3BG
- Institute of Neurology, University College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
We will recruit three groups of participants:
- functional neurological disorders, e.g. functional tremor: diagnosed by a neurologist.
- organic counterpart of the functional neurological disorders, e.g. in the case of functional tremor, the organic counterpart would be organic tremor: presence of an organic tremor according to internationally recognised guidelines and diagnosed by a neurologist.
- healthy age-matched controls.
Exclusion Criteria
- Healthy Participants: Major neurological disorder.
All groups:
- Age under 18 or over 80
- Significant impairment in ability to give informed consent for study procedures due to significant cognitive impairment and/or inability to understand study literature,
- very severe tremor
- moderate or severe cognitive impairment
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Functional neurological disorders
Initially especially patients diagnosed with a functional tremor.
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reaching studies and other behavioural studies.
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Organic neurological disorders.
Initially especially patients diagnosed with a an organic action tremor (e.g.
essential tremor or dystonic tremor).
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reaching studies and other behavioural studies.
|
Healthy control
Healthy age matched controls
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reaching studies and other behavioural studies.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tremor severity, assessed by kinematics, under different attentional conditions
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sense of agency, assessed by intentional binding, under different attentional conditions
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/0275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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