To assess in a pilot setting whether there are differences (including sensitivity and specificity) in pen motion, grip force patterns and muscle activity, derived using a newly developed system for handwriting monitoring, between A: patients with…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pen tip motion, velocity and acceleration and pen grip forces (in the time and
frequency domain) during each of the tasks, compared between groups. In
addition mean EMG, EMG variability and EMG power peaks will be assessed.
Secondary outcome
NA
Background summary
Earlier studies suggest that assessing the frequency and timing of force
modulation allows to quantify differences between healthy subjects and PD
patients who do not yet present the typical PD features, such as rest tremor,
limb stiffness and inability to perform voluntary movement. In the present
study, a newly developed system for handwriting monitoring that incorporates
finger grip force recordings is evaluated for its abilities to differentiate
between Parkinson*s disease and other movement disorders that show partially
similar symptoms (essential tremor, enhanced physiological tremor, psychogenic
tremor, dystonia and spasticity).
Study objective
To assess in a pilot setting whether there are differences (including
sensitivity and specificity) in pen motion, grip force patterns and muscle
activity, derived using a newly developed system for handwriting monitoring,
between A: patients with essential tremor, psychogenic tremor or enhanced
physiological tremor and B: patients with dystonia (writer*s cramp and
torticollis spasmodica), spasticity or Parkinson*s disease. Within study B, the
effect of Parkinsonian medication on the above measures will also be assessed.
Finally, to further assess future clinical value of the handwriting system, the
reproducibility of the above measures except muscle activity, will be
determined in healthy subjects (study C).
Study design
Observational study. Subjects have to execute line drawing, spiral and circle
drawing and text writing on a writing tablet while holding a pen that can
measure grip force. Arm joint kinematics will be determined using small
cameras. In addition EMG will be collected from lower- and upper arm muscles.
Study burden and risks
There are no risks or benefits, but a potential burden is associated with the
overnight (12 hour) withdrawal of anti-Parkinsonian medication in Parkinson
patients and the wash-out of medication in essential tremor patients (if
applicable). The burden is small however and if symptoms are increased due to
withdrawal/wash-out of medication, they will disappear soon after medication is
taken as usual. The withdrawal is justified because it allows to assess the
patients while they are not under the influence of their medication, which is
essential for this type of study.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
All subjects
- right*handed
- informed consent
- ability to hold a pen for at least half an hour
PD patients
- diagnosis according to the UK Parkinson*s Disease Society Brain Bank clinical diagnostic criteria
- symptoms scored as Hoehn & Yahr I*III
- age: >50 years
Essential tremor
- diagnosis according to the criteria defined by the Tremor Investigation Group for more than 5 years
Enhanced physiological tremor
- diagnosis based on polymyography
Psychogenic tremor
- diagnosis based on polymyography
Dystonia (writer*s cramp or torticollis spasmodica)
- clinical diagnosis of dystonia
- last botulinum toxin treatment at least 2 months prior to study investigation
Post*stroke spasticity
- clinical diagnosis of post*stroke spasticity (afflicting at least right hand function)
Exclusion criteria
All subjects
- (other) neurological or motor disorder (than that included for)
- Mini Mental State Examination (MMSE) score <26
- Use of medication influencing movement other than for Parkinson's disease or essential tremor
PD patients
- Not willing to comply with overnight-withdrawal of Parkinson-related medication
- Tremor-dominant PD
ET patients
- Not willing to comply with medication withdrawal, starting 7 days prior to study investigation
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 | NL35538.042.11 |