NCT02905877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

3.1 years

First QC Date

September 2, 2016

Last Update Submit

March 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tremor severity, assessed by kinematics, under different attentional conditions

    1 year

Secondary Outcomes (1)

  • Sense of agency, assessed by intentional binding, under different attentional conditions

    1 year

Study Arms (3)

Functional neurological disorders

Initially especially patients diagnosed with a functional tremor.

Other: Behavioural study

Organic neurological disorders.

Initially especially patients diagnosed with a an organic action tremor (e.g. essential tremor or dystonic tremor).

Other: Behavioural study

Healthy control

Healthy age matched controls

Other: Behavioural study

Interventions

reaching studies and other behavioural studies.

Functional neurological disordersHealthy controlOrganic neurological disorders.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

see below under inclusion criteria

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neurology, University College London

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 19, 2016

Study Start

September 1, 2016

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations