Our goal is to develop and validate a Movement Diagnostic System (MDS) to accurately locate specific CNS pathological changes in ET, PD-T and DYS, with the use of fMRI and scanner compatible EMG, accelerometry, video, and wrist perturbator.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differentiation between ET, PD-T and DYS based on brain activations
specifically related to involuntary movements. With external measures and
perturbation of the closed sensorimotor loop during fMRI we expect to find
involvement of the olivocerbellar networks in ET, the striatum in PD-T and a
widespread involvement of basal ganglia, thalamus, and cerebral cortex in
dystonia.
Secondary outcome
Observation and identification of the brain regions involved in (the early
stages) of movement disorders with overlapping symptoms will contribute to the
knowledge on the occurrences and causes of these diseases on a more fundamental
level.
Background summary
Essential tremor (ET), Parkinsonian tremor (PD-T) and limb dystonia (DYS) are
ubiquitous and disabling. Diagnostic tools are limited, especially in early
disease stages leading to a delay in targeted therapy. ET, PD-T and DYS are
diseases of the central nervous system (CNS), with different pathological
changes. Functional MRI (fMRI) combined with measures of movement including
electromyography (EMG) allows to relate voluntary and involuntary movements
directly to brain activity providing a promising diagnostic in movement
disorders. Combination with a wrist manipulator, influencing motor and sensory
inputs and outputs potentially allows *closed-loop system identification* and
may further improve movement disorders diagnostics.
Study objective
Our goal is to develop and validate a Movement Diagnostic System (MDS) to
accurately locate specific CNS pathological changes in ET, PD-T and DYS, with
the use of fMRI and scanner compatible EMG, accelerometry, video, and wrist
perturbator.
Study design
This is a pilot prospective cohort study. The study consists of Part A, outside
the scanner, including a standardized neurological assessment with standardized
rating scales and a measurement with wrist manipulator, EMG, accelerometry and
electroencephalogram (EEG) followed by Part B the main experiment inside the
scanner, including the MR-compatible devices with fMRI as a diagnostic tool .
Before this visit, a first visit is scheduled during which the eligibility of
the participants will be evaluated.
Study burden and risks
Participants will undergo one or two site visits. The first visit will take
about 1 hour during which the eligibility of the participants will be evaluated
by performing standardized clinical evaluations with the aid of inclusion
questionnaire and a short neurological examination. Preferably, this visit is
planned after a regular hospital visit. Patients are requested to slowly reduce
medication that suppresses the hyperkinetic symptoms prior to the second visit.
During this visit, two consecutive experimental set-ups will be performed. In
part A of the protocol, after clinical evaluation, participants will perform
motor tasks while perturbation torques are applied to the subject*s wrist by a
wrist manipulator. Recordings are made with surface EMG electrodes, kinematic
sensors, and EEG electrodes. This will take up to 1* hours including
preparation. After an hour break we will continue with part B. In this stage,
the severity of the symptoms is known and the perturbation protocol is tailored
to the specific participants. Participants will perform motor tasks and
perturbation torques are applied during fMRI measurement. Motor responses are
measured with the same EMG electrodes and kinematic sensors as in part A.
Participants will be in the scanner for one hour. The second visit will take
approximately 3.5 hours in total, including one hour break. The proposed
investigation bears virtually no risks and is expected to be well-tolerated.
All safety requirements regarding the instruments used in this study will be
met in accordance with *instrumenteel bedrijf* and the clinical physicists
responsible for the MRI. The developed system potentially improves diagnosis of
movement disorders, thus shortening the diagnostic procedure and improving the
treatment effectiveness. There is no direct benefit from this study for the
participants.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
• 18 years or older
• Right-handed according to the Edinburgh Handedness Inventory
• Willingness to stop medication intake for eight hours prior to investigations
And either:
• Essential tremor according to criteria defined by the Tremor Investigation Group, moderate to severe tremor (Tremor Rating Scale Part A 2 UE>2) ;
Hereditary ET (positive family history: at least one affected relative in immediate family;
Onset in patient and family member before age 65);
Positive effect of propranolol on tremor.
• Parkinson*s disease according to the UK Brain Bank criteria for Parkinson*s disease;
No major fluctuations in symptoms due to medication;
No severe dyskinesia.
• Limb dystonia with at least 35 points on the motoric part of the Burke-Fahn-Marsden Dystonia Rating Scale
• Healthy age and sex-matched controls
Exclusion criteria
• MR-incompatible implanted metal bodies, including stereotactic implant for Deep Brain Stimulation and pacemakers.
• Other contraindications for MR (Claustrophobia, obesity, etc.)
• Use of medicines/drugs that could influence the performance during the tasks (such as anti-epileptic drugs, neurodepressants, etc.)
• Pregnancy or suspected pregnancy
• Incapability to give informed consent
• Other neurological disorder than ET/PD-T/dystonia including dementia
• Abnormalities of the hand/wrist or prior surgery of the hand/wrist
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 |
|---|---|
| Other | 9427 (trialregister) |
| CCMO | NL35362.018.11 |