We aim to study the contributing factors to movement disorder symptoms in subjects with a FMD using a web based diary. At the same time, objective symptom assessment will be performed using an actigraphy wristband. Associations between potential…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Contributing factors to objective (and/or) subjective symptom fluctuation in
individual patients.
Secondary outcome
The following possible contributing factors will be studied:
- Positive And Negative Affect Schedule (PANAS)
- Physical activity
- Fatigue
- Attention (in terms of social or mental activities)
- Personal factor
Furthermore, to measure the effect of the study, patient will complete
questionnaires on self-belief (General Self-Efficacy Scale), quality of life
(EQ-5D), and clinical global impression (CGI)
Background summary
Functional movement disorders (FMD) are hard to diagnose and treat. The
underlying etiology of FMDs remains poorly understood with several postulated
mechanisms and an acknowledgement of the contribution of biological,
psychogenic, and cultural factors. The old term *psychogenic* movement
disorders suggests a psychological background of FMD, but case-control studies
have demonstrated only an assocation, and not causation, between psychogenic
factors and FMDs in a subset of patients. Besides, many somatic symptoms are
strongly associated with psychiatric disorders, so these psychogenic factors
are probably also relevant in neurological movement disorders disorders.
An alternative means of investigation is to study patients on an individual
basis, attempting to identify which factors contribute the most to the
patient*s symptoms. This is possible by applying a multivariate time-series
analysis. In this study, we will use a web based diary system to focus on
contributing factors that are known to modulate functional symptoms. At the
same time we will use actigraphy to objectively assess the patients symptoms.
Study objective
We aim to study the contributing factors to movement disorder symptoms in
subjects with a FMD using a web based diary. At the same time, objective
symptom assessment will be performed using an actigraphy wristband.
Associations between potential contributing factors and symptom fluctuations in
FMD patients will be compared with those in a group with other neurological
movement disorders.
Study design
A replicated single-subject time-series design will be used. Patients with a
(functional or neurological) movement disorder will be monitored for 30 days,
five times a day, by using a web based diary. In addition, patients will wear
an actigraphy wristband during daytime.
Study burden and risks
There are no risks involved in participating in the study. The burden
associated with participation consists of:
(1) An inclusion interview with video measurement; a screening for depression,
anxiety, and somatisation; and completing questionnaires on self-efficacy,
quality of life, and clinical global impression (total of 45 minutes).
(2) Wearing an actigraphy wristband during daytime, and completion of an
internet based diary at fixed times (5 x 5 minutes a day) during the study
period (30 days).
(3) At the end of the study period, subjects will receive an e-mail to give
general feedback to the study and will be asked for the second time to complete
the questionnaires on self-efficacy, quality of life, and clinical global
impression (30 minutes)
(4) One month the end of 30 days measuring, subjects will receive a third time
the questionnaires on self-efficacy, quality of life, and clinical global
impression to determine whether they benefited from participating in this study
(10 minutes).
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Age > 18
- Functional movement disorder, according to Fahn criteria, as judged by a neurologist
Or a neurological movement disorder, as judged by a neurologist.
- Symptom duration > 1 year
- capable of keeping an electronic diary five times a day and have acces to internet at 9.00; 12.00; 15.00; 18.00; 21.00
Exclusion criteria
- current medical treatment with botulinum
- psychological treatment in the previous 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL55993.042.15 |