Gait Disorders in Parkinson's Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | November 19, 2018 |
| End Date: | October 31, 2019 |
| Contact: | Elaine P Considine, R.N. |
| Email: | considinee@ninds.nih.gov |
| Phone: | (301) 435-8518 |
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
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).
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).
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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