Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467597
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2007-04-27
Brief Title:
Developing Objective Measures of Levodopa Induced Dyskinesia Study 1
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Quantification of Levodopa Induced Dyskinesia in Parkinson Disease Developing Objective Measures of Levodopa Induced Dyskinesia Study One
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The ultimate goal of this proposal is to reduce dyskinesia in Parkinsons Disease PD patients Dyskinesias are abnormal movements often caused by the standard treatment for PD symptoms levodopa In this study we will test if biochemical devices are equal to the clinical rating system in measuring dyskinesias
Detailed Description:
Levodopa induced dyskinesia LID is a major problem associated with chronic use of levodopa LD for symptomatic treatment of Parkinsons disease PD LD remains our most potent therapy and nearly all PD patients will use it A substantial portion of them will experience LID with the impact ranging from non-interfering to severely disabling The objective of this study is to develop reliable and sensitive objective measures of LID that will quantify muscular control and postural stability in subjects with dyskinesia
While the gold standard of measuring LID is the subjective RS we will determine if objective biochemical devices will equal the reliability and validity of CRS We hypothesize that force plate technology quantifies postural sway movements best and pinch-grip will best quantify muscle overflow force during voluntary movements
We will compare two biomechanical devices and a traditional clinical rating scale CRS Once biomechanical instrument measures LID in the setting of voluntary muscle activity the other acquires LID data related to postural sway A cross-section of LD-treated patients with and without clinically apparent dyskinesia will be used to assess the measures
32 subjects will be invited to participate 24 with PD and 8 age-matched controls likely unaffected spouses without neurologic disease Of the PD patients 7 will have no clinically apparent dyskinesia 7 will have mild dyskinesia and 7 with moderate to severe dyskinesia will be recruited 3 additional subjects are included to account for missing data or drop-outs
They will comfortably stand with their feet placed in a preset marked stance on the force plate either with or without a mental task and pick up a pinch-grip device multiple times Testing will be done in the effective motor on and off states to establish validity and reliability of instrument data as these states often reflect the usual clinical experience of patients The second method for rating dyskinesia will be the Clinical Rating Scale Subjects will be rated while standing on the force plate during both mental task and non-mental task conditions
All subjects will undergo this testing Healthy subjects will undergo this testing three times during one visit Subjects with PD will be admitted overnight and have seven testing periods which will vary in the number of times the procedures will be done Inpatient subjects will also receive 1mgkghr or 15mgkghr of intravenous levodopa depending on their everyday usage of levodopa or levodopa equivalent medications for 2 hours 9AM - 11AM with carbidopa 25 mg po at 8AM 10AM and noon to prevent nausea
While the gold standard of measuring LID is the subjective RS we will determine if objective biochemical devices will equal the reliability and validity of CRS We hypothesize that force plate technology quantifies postural sway movements best and pinch-grip will best quantify muscle overflow force during voluntary movements
We will compare two biomechanical devices and a traditional clinical rating scale CRS Once biomechanical instrument measures LID in the setting of voluntary muscle activity the other acquires LID data related to postural sway A cross-section of LD-treated patients with and without clinically apparent dyskinesia will be used to assess the measures
32 subjects will be invited to participate 24 with PD and 8 age-matched controls likely unaffected spouses without neurologic disease Of the PD patients 7 will have no clinically apparent dyskinesia 7 will have mild dyskinesia and 7 with moderate to severe dyskinesia will be recruited 3 additional subjects are included to account for missing data or drop-outs
They will comfortably stand with their feet placed in a preset marked stance on the force plate either with or without a mental task and pick up a pinch-grip device multiple times Testing will be done in the effective motor on and off states to establish validity and reliability of instrument data as these states often reflect the usual clinical experience of patients The second method for rating dyskinesia will be the Clinical Rating Scale Subjects will be rated while standing on the force plate during both mental task and non-mental task conditions
All subjects will undergo this testing Healthy subjects will undergo this testing three times during one visit Subjects with PD will be admitted overnight and have seven testing periods which will vary in the number of times the procedures will be done Inpatient subjects will also receive 1mgkghr or 15mgkghr of intravenous levodopa depending on their everyday usage of levodopa or levodopa equivalent medications for 2 hours 9AM - 11AM with carbidopa 25 mg po at 8AM 10AM and noon to prevent nausea
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None