Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03416452
Status:
WITHDRAWN
Last Update Posted:
2018-11-20
First Post:
2018-01-30
Brief Title:
Gait Disorders in Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Gait Disorders in Parkinsons Disease
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left the NIH
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Parkinson s disease PD is a neurologic disorder that causes slowness tremor rigidity and imbalance Gait impairment is also common There are 2 substudies 1 Physiology of Freezing and Gait 2 Vibratory Cueing Healthy participants can join only Substudy 1
Objective
To study gait disorders in PD Also to test the effect of specific interventions for gait in people with PD
Eligibility
People ages 18 and older who
Have PD with bilateral symptoms but can walk without a cane or walker
Are healthy
Design
Participants will be screened in Protocols 93-N-0202 and 01-N-0206
Both substudies include a physical exam and medical history
Substudy 1
Participants will have one 6-hour visit They must wear a tank tops and shorts with tennis shoes during the visit They will perform gait tasks Markers placed on the skin will record movements They will have an EEG They will wear an electrode cap to record brain waves They will wear special glasses to record eye movements Participants with PD will hold their morning dose of PD drugs They can choose to be admitted to the hospital the previous evening Otherwise someone else or a taxi must bring them to the visit They will first perform the study tasks off their drugs Then they will take their drugs and repeat them
Substudy 2
Participants will have one 3-hour visit A small vibratory device will be attached to their ankle Reflective markers placed on the skin will record movements while they walk
Without the device
With the device but the vibrator off
With the device with the vibrator on
With a magnet attached to the ankle
Parkinson s disease PD is a neurologic disorder that causes slowness tremor rigidity and imbalance Gait impairment is also common There are 2 substudies 1 Physiology of Freezing and Gait 2 Vibratory Cueing Healthy participants can join only Substudy 1
Objective
To study gait disorders in PD Also to test the effect of specific interventions for gait in people with PD
Eligibility
People ages 18 and older who
Have PD with bilateral symptoms but can walk without a cane or walker
Are healthy
Design
Participants will be screened in Protocols 93-N-0202 and 01-N-0206
Both substudies include a physical exam and medical history
Substudy 1
Participants will have one 6-hour visit They must wear a tank tops and shorts with tennis shoes during the visit They will perform gait tasks Markers placed on the skin will record movements They will have an EEG They will wear an electrode cap to record brain waves They will wear special glasses to record eye movements Participants with PD will hold their morning dose of PD drugs They can choose to be admitted to the hospital the previous evening Otherwise someone else or a taxi must bring them to the visit They will first perform the study tasks off their drugs Then they will take their drugs and repeat them
Substudy 2
Participants will have one 3-hour visit A small vibratory device will be attached to their ankle Reflective markers placed on the skin will record movements while they walk
Without the device
With the device but the vibrator off
With the device with the vibrator on
With a magnet attached to the ankle
Detailed Description:
The objective of this protocol is to study the physiology of gait disorders in Parkinson s disease as well as to test the effect of non-invasive interventions on gait function in patients with Parkinson s disease To this end this protocol will consist of two sub studies
1 Sub Study 1 Physiology of Freezing of Gait in Parkinson Disease abbrev Physiology of FOG
1 Objective To explore temporospatial gait parameters and joint kinematic patterns in patients with Parkinson disease and freezing of gait In addition tracking of eye movements and EEG patterns will also be studied in patients with Parkinson disease and freezing of gait
2 Study Population 15 PD patients with freezing of gait 15 patients without freezing of gait 15 age and gender matched healthy volunteers
3 Design Prospective Exploratory study
4 Outcome Measures Phase variability and coherence of oscillating axial and appendicular components of gait in patients with PD and freezing of gait visual gaze fixations and saccades during freezing or freezing-like events and when approaching a variable width doorway EEG patterns during an episode of freezing of gait or freeze-like event The study will also aim to look at the difference in the phenomenon of FOG in OFF and ON states
2 Sub Study 2 Effects of Rhythmic Vibratory Cueing to Improve Step Parameters in Parkinson Disease abbrev Vibratory Cueing
1 Objective To study changes in gait variables of patients with PD by providing rhythmic vibratory stimuli at the ankle on one limb at preset parameters
2 Study population 15 patients diagnosed as having Parkinson s Disease Hoehn and Yahr stage 2-3
3 Design Prospective interventional hypothesis testing study We will evaluate the effects of rhythmic vibratory cueing on gait variables in PD The effects of vibratory cueing will be tested compared to baseline gait variables and with the use of a magnet which will be the open label placebo intervention to account to some extent for the open label design
1 Sub Study 1 Physiology of Freezing of Gait in Parkinson Disease abbrev Physiology of FOG
1 Objective To explore temporospatial gait parameters and joint kinematic patterns in patients with Parkinson disease and freezing of gait In addition tracking of eye movements and EEG patterns will also be studied in patients with Parkinson disease and freezing of gait
2 Study Population 15 PD patients with freezing of gait 15 patients without freezing of gait 15 age and gender matched healthy volunteers
3 Design Prospective Exploratory study
4 Outcome Measures Phase variability and coherence of oscillating axial and appendicular components of gait in patients with PD and freezing of gait visual gaze fixations and saccades during freezing or freezing-like events and when approaching a variable width doorway EEG patterns during an episode of freezing of gait or freeze-like event The study will also aim to look at the difference in the phenomenon of FOG in OFF and ON states
2 Sub Study 2 Effects of Rhythmic Vibratory Cueing to Improve Step Parameters in Parkinson Disease abbrev Vibratory Cueing
1 Objective To study changes in gait variables of patients with PD by providing rhythmic vibratory stimuli at the ankle on one limb at preset parameters
2 Study population 15 patients diagnosed as having Parkinson s Disease Hoehn and Yahr stage 2-3
3 Design Prospective interventional hypothesis testing study We will evaluate the effects of rhythmic vibratory cueing on gait variables in PD The effects of vibratory cueing will be tested compared to baseline gait variables and with the use of a magnet which will be the open label placebo intervention to account to some extent for the open label design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-N-0050 | None | None | None |