Condition category
Nervous System Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
04/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K Colman

ORCID ID

Contact details

Oude Kijk in’t 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 in’t 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

http://www.rug.nl/corporate/index?lang=en

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

Publication citations

Additional files

Editorial Notes