Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 36836 for:    neurological disorders

The Pathophysiology of Functional Neurological Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02905877
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief 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.


Condition or disease Intervention/treatment
Functional Neurological Disorders Other: Behavioural study

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: The Pathophysiology of Functional Neurological Disorders
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Tremor severity, assessed by kinematics, under different attentional conditions [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Sense of agency, assessed by intentional binding, under different attentional conditions [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
see below under inclusion criteria
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905877


Contacts
Layout table for location contacts
Contact: Anne-Catherine Huys, MD 0044 20 3448 8605 anne-catherine.huys.15@ucl.ac.uk

Locations
Layout table for location information
United Kingdom
Institute of Neurology, University College London Recruiting
London, United Kingdom, WC1N 3BG
Contact: Anne-Catherine Huys, MD    0044 20 3448 8605    anne-catherine.huys.15@ucl.ac.uk   
Sub-Investigator: Anne-Catherine Huys, MD         
Sponsors and Collaborators
University College, London

Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02905877     History of Changes
Other Study ID Numbers: 16/0275
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Conversion Disorder
Nervous System Diseases
Pathologic Processes
Somatoform Disorders
Mental Disorders