To validate SAI as a measure for cholinergic innervation by relating SAI directly to [18F]FEOBV PET imaging. The secundary aims are as follows: - To assess the correlation between SAI and cognitive functioning, motor symptoms, RBD, walking speed,…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter resulting from the SAI-measurement is percentage of
conditioned motor evoked potential (MEP) versus unconditioned MEP. The main
study parameter resulting from [18F]FEOBV PET imaging is the mean cortical
tracer binding. We will perform a correlation analysis between these parameters
as a main outcome measure.
Secondary outcome
- Tracer binding in different ROIs and per voxel.
- Outcome of all questionnaires and clinical tests as mentioned under E4.
- Resting-state functional connectivity.
Background summary
Parkinson*s disease (PD) is a complex neurodegenerative disorder, involving
multiple neurotransmitter systems. It has been shown that degeneration of the
cholinergic system in PD is related to both motor and nonmotor symptoms,
including cognitive impairment, REM-sleep behavioural disorder (RBD), visual
hallucinations (VHs), hyposmia, postural instability and gait disorder. Several
methods exist for imaging of the cholinergic system in vivo, although they are
not routinely performed in clinical practice due to their cost, limited
availability and radiation burden for the patient. Short-latency afferent
inhibition (SAI) might be a relatively cheap and non-invasive alternative for
fast in vivo assessment of the cholinergic system.
Study objective
To validate SAI as a measure for cholinergic innervation by relating SAI
directly to [18F]FEOBV PET imaging. The secundary aims are as follows:
- To assess the correlation between SAI and cognitive functioning, motor
symptoms, RBD, walking speed, VHs, olfactory function and speech.
- To explore the accuracy of resting-state functional connectivity as a
reflection of cholinergic innervation in Parkinson*s disease.
- To explore to what extend SAI and resting-state functional connectivity can
pick up changes in cognitive functioning, motor symptoms, RBD, walking speed,
VHs, olfactory function and speech that result from active perturbation of the
cholinergic system.
Study design
This is a method-comparison study aiming to assess the correlation between SAI
and [18F]FEOBV PET.
Study burden and risks
In de PET imaging, 200 MBq is injected, resulting in a radiation burden of 4.6
mSv. For attenuation correction a low-dose CT is added to each PET scan
performed. This accounts for an additional radiation burden of 1.5 mSv.
According to recommendations from the International commission of radiological
protection (ICRP) a dose of 1-10 mSv in one year for volunteers for biomedical
research, falls in a moderate risk category (The 2007 recommendations of the
international commission on radiological protection. ICRP publication 103.2007).
There are no known risks of paired-pulse TMS, although it may lead to a mild
transient headache due to contraction of scalp muscles. (Rossi et al. 2009).
For the PD-D patients, treatment with rivastigmine (the ChEI of choice) may be
delayed until after the measurements. This delay includes the time of the
patient to consider participation and the time to schedule the measurements.
This means that the symptoms that are supposed to be treated with rivastigmine
might persist longer. However, rivastigmine is not prescribed in an acute
setting and there is no reason to believe that rivastigmine can halt the
underlying pathology of the symptoms.
Antonius Deusinglaan 2
Groningen 9713AW
NL
Antonius Deusinglaan 2
Groningen 9713AW
NL
Listed location countries
Age
Inclusion criteria
- Willingness to cooperate and sign written informed consent
Patients:
- Clinical diagnosis of idiopathic Parkinson*s disease by a neurologist.
Exclusion criteria
- Incapable to provide informed consent
- Treatment with anticholinergics
- Current or recent treatment with ChEIs
- Presence of deep brain stimulation implants
- (Suspected) pregnancy
- Migraine
- Epilepsy
- Participation in a scientific research study during the past year involving
radiation
- MRI contra-indications, e.g.
o Ferrous objects in or around the body (e.g. braces, pacemaker, metal
fragments)
o Claustrophobia
- Insufficient knowledge of the Dutch language
Control subjects:
- History of neurological or neurodegenerative disorder
Parkinson Disease Dementia:
- Unsafe or irresponsible to postpone treatment with cholinesterase inhibitor,
according to treatment provider
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 | NL72060.042.19 |
| Other | NL7838 |