| - candidate number | 2265 |
| - NTR Number | NTR782 |
| - ISRCTN | ISRCTN18548326 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 26-sep-2006 |
| - Secondary IDs | N/A |
| - Public Title | Brain activation during sentence processing in Parkinson's disease: an event related fMRI-study. |
| - Scientific Title | Brain activation during sentence processing in Parkinson's disease: an event related fMRI-study. |
| - ACRONYM | N/A |
| - hypothesis | We hypothesise that basal ganglia 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. |
| - Healt Condition(s) or Problem(s) studied | Parkinson's disease |
| - 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 MRI scan |
| - Exclusion criteria | 1. Not optimally medicated 2. Neurostimulator 3. Implanted pump (e.g. apomorphine) 4. Dementia (MMSE-score < 25) 5. Depression (MADRS > 18) 6. Another neurological disease 7. Another akinetic-rigid disorder 8. Another movement disorder 9. No normal structural MRI scan |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | [default] |
| - Studytype | observational |
| - planned startdate | 1-dec-2006 |
| - planned closingdate | 1-dec-2007 |
| - Target number of participants | 32 |
| - Interventions | No interventions. It is observational research with the use of FMRI (no use of invasive techniques). |
| - Primary outcome | 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 grammatical incorrect sentences will activate the BG more compared to the processing of the grammatical correct sentences. For the behaviourally 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 | N/A |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. K. Colman |
| - CONTACT for SCIENTIFIC QUERIES | Drs. K. Colman |
| - Sponsor/Initiator | University of Groningen, Faculty of Arts, Neurolinguistics |
| - Funding (Source(s) of Monetary or Material Support) | Stichting Internationaal Parkinson Fonds |
| - Publications | Presentations on conferences and articles in scientific journals. |
| - Brief summary | Linguistic research has revealed that some Parkinson’s disease (PD) patients demonstrate difficulties with the comprehension of syntactically complex or rather long sentences. However, it remains unclear whether cognitive limitations such as working memory (WM), attention, and information processing speed (IPS) account for the comprehension difficulties of PD (e.g. Grossman et al., 1992; Grossman et al., 2000; Grossman et al., 2002; Lee et al., 2003); or whether the impaired sentence comprehension is due to a specific grammatical processing deficit (Lieberman et al., 1992; Natsopoulos et al., 1993; Natsopoulos et al., 1991). Up until today, relatively little is known about the involvement of the BG and/or fronto-striatal system in sentence comprehension. PD is one of the disorders of the basal ganglia. In order to evidence the involvement and the function of the BG in linguistic processes, we can study this group of patients while performing language tasks. We hypothesise that whenever the structure of a sentence deviates from the predicted syntactic structure (because of for example and error), the BG are involved in order to inhibit the irrelevant structure and to switch to a revision process. Objective: The primary goal of this study is to understand the sentence comprehension difficulties in Dutch speaking PD patients. Secondly, we developed the two experiments to test the hypothesis that the BG are involved and play a particular role in syntactic processing. |
| - Main changes (audit trail) | |
| - RECORD | 26-sep-2006 - 18-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl