Functional Neurological Disorders Clinical Trial
Official title:
The Pathophysiology of Functional Neurological Disorders
NCT number | NCT02905877 |
Other study ID # | 16/0275 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | September 30, 2019 |
Verified date | March 2020 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - We will recruit three groups of participants: 1. functional neurological disorders, e.g. functional tremor: diagnosed by a neurologist. 2. 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. 3. healthy age-matched controls. Exclusion Criteria - Healthy Participants: Major neurological disorder. All groups: 1. Age under 18 or over 80 2. Significant impairment in ability to give informed consent for study procedures due to significant cognitive impairment and/or inability to understand study literature, 3. very severe tremor 4. moderate or severe cognitive impairment |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Institute of Neurology, University College London | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tremor severity, assessed by kinematics, under different attentional conditions | 1 year | ||
Secondary | Sense of agency, assessed by intentional binding, under different attentional conditions | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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