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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2020
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Behavioural study
reaching studies and other behavioural studies.

Locations

Country Name City State
United Kingdom Institute of Neurology, University College London London

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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
See also
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