Gait Disorders in Parkinson's Disease
Gait Disorders in Parkinson's Disease
Sponsors
Source
National Institutes of Health Clinical Center (CC)
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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
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).
Overall Status
Withdrawn
Start Date
2018-01-24
Completion Date
2018-11-13
Primary Completion Date
2018-11-13
Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
To examine the relative phase variability or coherence between oscillating axial and appendicular components of gait in PD + FOG, compared to PD-FOG and healthy controls. |
ongoing |
Changes in Stride length |
ongoing |
Condition
Intervention
Intervention Type
Device
Intervention Name
Description
ankle brace with vibrator that provides electric stimulus
Arm Group Label
PD patients 1
PD patients
Intervention Type
Device
Intervention Name
Description
standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps
Arm Group Label
Healthy Volunteers
Healthy
PD patients no
Eligibility
Criteria
- INCLUSION CRITERIA:
- Age 18 years or older
- Able to provide informed consent
- Clinical diagnosis of Parkinson disease by U.K. Parkinson Society Brain Bank Criteria
- Patients must be stage II -III on the Hoehn and Yahr scale
EXCLUSION CRITERIA:
- MoCA<25 within the last 6 months
- Uncontrolled medical condition requiring immediate treatment that would make a walking
trial unsafe for the subject.
- Peripheral neuropathy that severely limits gait
- Current or recent orthopedic disorder that severely limits gait
- Current uncontrolled depression or major depressive episode
- Gait disorders other than PD.
- Cannot walk safely without corrective lenses and without support.
- Unable to abstain from PD medications overnight for at least 12 hours before testing
- History of deep brain stimulation surgery
- Subjects who are NINDS employees
- In addition to the preceding criteria, healthy volunteers must also have a normal
neurological examination performed within the last year. Healthy volunteers will be
healthy subjects without any major medical and neurological or psychiatric disorders
established by history and physical/neurological examination. They will also have no
gait disorders from any medical or surgical problems as per clinical assessment.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
Shabbir Hussain I Merchant, M.D. |
Principal Investigator |
National Institute of Neurological Disorders and Stroke (NINDS) |
Verification Date
2018-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
18-N-0050
Number Of Arms
5
Arm Group
Arm Group Label
PD patients no
Arm Group Type
Experimental
Description
PD patients without freezing of gait
Arm Group Label
Healthy
Arm Group Type
Placebo Comparator
Description
HV using Mobile Gait Trainer
Arm Group Label
PD patients
Arm Group Type
Experimental
Description
pd patients using vibratory cueing device
Arm Group Label
PD patients 1
Arm Group Type
Experimental
Description
PD patients with freezing of gait
Arm Group Label
Healthy Volunteers
Arm Group Type
Experimental
Description
Age and gender matched healthy volunteers.
Firstreceived Results Date
N/A
Why Stopped
Investigator left the NIH.
Reference
Citation
Kelly VE, Eusterbrock AJ, Shumway-Cook A. The effects of instructions on dual-task walking and cognitive task performance in people with Parkinson's disease. Parkinsons Dis. 2012;2012:671261. doi: 10.1155/2012/671261. Epub 2012 Dec 29.
PMID
23326758
Removed Countries
Country
United States
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)
Study First Submitted
January 30, 2018
Study First Submitted Qc
January 30, 2018
Study First Posted
January 31, 2018
Last Update Submitted
November 19, 2018
Last Update Submitted Qc
November 19, 2018
Last Update Posted
November 20, 2018
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.