The Pathophysiology of Functional Neurological Disorders

March 25, 2020 updated by: University College, London

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3BG
        • Institute of Neurology, University College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

see below under inclusion criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: Behavioural study
reaching studies and other behavioural studies.
Organic neurological disorders.
Initially especially patients diagnosed with a an organic action tremor (e.g. essential tremor or dystonic tremor).
Other: Behavioural study
reaching studies and other behavioural studies.
Healthy control
Healthy age matched controls
Other: Behavioural study
reaching studies and other behavioural studies.

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

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

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)?

No

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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