Contact information
Type
Scientific
Primary contact
Dr K Colman
ORCID ID
Contact details
Oude Kijk int Jatstraat 26
Groningen
9712 EK
Netherlands
+31 (0)50 363 8135
k.s.f.colman@rug.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR782
Study information
Scientific title
Acronym
Study hypothesis
We hypothesise that basal ganglia (BG) are involved in sentence processing whenever a sentence structure deviates from the predicted structure and this in order to inhibit the irrelevant structure and to switch to a revision process.
Ethics approval
Not provided at time of registration
Study design
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Condition
Parkinson's disease
Intervention
No interventions. It is observational research with the use of functional magnetic resonance imaging (fMRI) (no use of invasive techniques).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
For the fMRI analysis data, a main effect of group is expected. The level of activation in the BG will be reduced in the PD patient group compared to the healthy control group. For the within subject factors we expect to find a main effect of grammaticality. In the healthy elderly subject group, we expect that the processing of the grammatically incorrect sentences will activate the BG more compared to the processing of the grammatically correct sentences. For the behavioural data, we expect to find slower reaction times (RTs) for the processing of non-canonical ungrammatical sentences (i.e. passive sentences with a violation) in both subject groups. However the RTs will be significantly more affected in the PD group compared to the healthy elderly subject group.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/12/2006
Overall trial end date
01/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Idiopathic Parkinson's disease (PD)
2. Hoehn and Yahr stage 1 to stage 3
3. Normal vision and hearing
4. Able to give informed consent
5. Older than 40 years
6. Dutch as first language
7. Right-handed
8. Normal structural magnetic resonance imaging (MRI) scan
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
32
Participant exclusion criteria
1. Not optimally medicated
2. Neurostimulator
3. Implanted pump (e.g. apomorphine)
4. Dementia (Mini Mental State Examination [MMSE] score less than 25)
5. Depression (Montgomery-Asberg Depression Rating Scale [MADRS] more than 18)
6. Another neurological disease
7. Another akinetic-rigid disorder
8. Another movement disorder
9. No normal structural MRI scan
Recruitment start date
01/12/2006
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Oude Kijk int Jatstraat 26
Groningen
9712 EK
Netherlands
Sponsor information
Organisation
University of Groningen (The Netherlands)
Sponsor details
Faculty of Arts
Neurolinguistics
Postbus 196
Groningen
9700 AD
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Stichting Internationaal Parkinson Fonds (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary