To gain insight in the cognitive basis of the positive effect of apomorphine on visual hallucinations in Parkinson's disease (PD)
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in prestation on the VOSP related to the presence or absence of the
apomorphine infusion.
Secondary outcome
1. Lower order visual perception tests consisting of Mars Letter Contrast
Sensitivity Test, Visual field measurement, Primary vision measurement, Color
differentiation, Visual overview and perceptual speed (TAVTMB).
2. Cognitive and attentional tests consisting of reactiontime (Schuhfried S7),
Frontal Lobe assessment Battery (FAB) and the SCOPA-Cog
3. Motor function test consisting of the SPES/ SCOPA.
Background summary
Visual hallucinations in parkinson's disease are often seen as overstimulation
of the dopamine receptors, induced by medication. Dopamine agonist, like
apomorphine, are therefore seen as not suitable for the treatment of patients
with parkinson's disease and visual hallucinations. In a recent studie
apomorphine appeared to have a positive effect on the hallucinations in these
patients. In this study the visual and cognitive basis of this change will be
studied.
Study objective
To gain insight in the cognitive basis of the positive effect of apomorphine on
visual hallucinations in Parkinson's disease (PD)
Study design
This is a pilot study with 10 patients only, to test the hypothesis that the
reported positive effects of apomorphine on VH in PD patients are caused by
pathological visual processing in these patients.
Methodology
Selection of 10 patients with PD and visual hallucinations (VH)
Baseline scores of visual perception, cognition and attention
Repeated scores after 4 months (based on a known re-test effect within 4
months), initially during an infusion of apomorphine during 3 hours
(40ug/kg/hr) and for the second time 3 hrs. after having stopped this infusion.
Intervention
The application of apomorphine via a subcutaneous infusion during three hours.
Study burden and risks
The participants are tested neuropsychologically on two occasions. The first
time is a baseline measurement without apomorphine. The second time is four
months later when the patients stays in the hospital during one day. On that
day there are two test sessions; one while there is as infusion of apomophine
and a second test when the apomorphine effect has gone. The risks for the
paticipants are therefore very small. Apomorphine is a drug which is regularly
used in the treatment of patients with Parkinson's disease. Moreover, any
negative effects that may occur are of a short duration because of the short
half-life of apomorphine.
Hanzeplein 1
9713GZ Groningen
NL
Hanzeplein 1
9713GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosed Parkinson*s Disease according to the UK Brain Bank Criteria
2. Al least weekly hallucinations during the past month
3. MMSE >24
4. FAB>=12
5. Patient must be able to understand the procedure
6. Medication must be stable for at least a month
Exclusion criteria
1. Visual problems (cataract, macula degeneration, severe retinal patholgy, visus<.5)
2. Patients with cerebral electrodes for deep brain stimulation
3. Presence of other neurological or psychiatric affections
4. Unstable internal disease
5. Patients who already use apomorphine
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2007-007936-24-NL |
| CCMO | NL21163.042.07 |