- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01935011
DBS Frequency on Swallowing Function in Parkinson's Disease
Effects of the Stimulation Frequency of STN DBS on Swallowing Function in Patients With Parkinson's Disease
Studieoversigt
Detaljeret beskrivelse
This is the first study on the effect of the stimulation frequency on swallowing function in PD patients with STN DBS. Swallowing dysfunction is often difficult to treat pharmacologically and associated with increased morbidity and mortality. This study hence would have significant clinical implications in the management of swallowing dysfunction in these PD patients with STN DBS and could potentially decrease their morbidity and mortality.
The investigators expect that the traditionally high frequency stimulation of 130 Hz would worsen while the low frequency stimulation of 60 Hz would improve the swallowing function in OPMS summary
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.
Exclusion Criteria:
- Patients who do not meet the inclusion criteria
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
PD DBS 60 Hz, 130 Hz or DBS off
PD DBS on 60 Hz stimulation, 130 Hz stimulation or DBS off
|
PD DBS frequency on swallowing function
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The primary outcome would be the OPMS swallowing function scores
Tidsramme: One year
|
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled.
Information on the oropharyngeal motility study (OPMS) of the oral, pharyngeal and esophageal phase function will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz".
Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart.
The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
ANOVA will be used for group comparison of the scores.
A regression model will be further used to assess the predicting value (s) of the other scores and demographics for the swallowing function.
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One year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The secondary outcome would be the swallowing questionnaire score
Tidsramme: One year
|
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled.
Information on the swallowing questionnaire will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz".
Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart.
The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
|
One year
|
The secondary outcome would also be the unified PD rating scale
Tidsramme: One year
|
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled.
Information on the unified PD rating scale will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz".
Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart.
The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
|
One year
|
The secondary outcome would be the FOG questionnaire score
Tidsramme: One year
|
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled.
Information on the FOG questionnaire will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz".
Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart.
The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
|
One year
|
The secondary outcome would be the standing-walking-sitting test score
Tidsramme: One year
|
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled.
Information on the standing-walking-sitting test will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz".
Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart.
The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
|
One year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Tao Xie, MD PhD, University of Chicago
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13-0566
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