Brain activation during sentence processing in Parkinson's disease: an event related functional magnetic resonance imaging study

ISRCTN	ISRCTN18548326
DOI	https://doi.org/10.1186/ISRCTN18548326
Secondary identifying numbers	NTR782

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 04/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr K Colman
Scientific

Oude Kijk int Jatstraat 26
Groningen
9712 EK
Netherlands

Phone	+31 (0)50 363 8135
Email	k.s.f.colman@rug.nl

Study information

Study design	Observational case-control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Not specified
Study type	Screening
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/12/2006
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	32
Key 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
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Oude Kijk int Jatstraat 26

Groningen
9712 EK
Netherlands

Sponsor information

University of Groningen (The Netherlands)
University/education

Faculty of Arts
Neurolinguistics
Postbus 196
Groningen
9700 AD
Netherlands

Website	http://www.rug.nl/corporate/index?lang=en
"ROR"	https://ror.org/012p63287

Funders

Funder type

Industry

Stichting Internationaal Parkinson Fonds (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan