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Gait Disorders in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03416452
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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


Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: vibratory cueing device Device: Mobile Gait Trainer Early Phase 1

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Gait Disorders in Parkinson's Disease
Estimated Study Start Date : June 26, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PD patients no
PD patients without freezing of gait
Device: Mobile Gait Trainer
standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps

Placebo Comparator: Healthy
HV using Mobile Gait Trainer
Device: Mobile Gait Trainer
standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps

Experimental: PD patients
pd patients using vibratory cueing device
Device: vibratory cueing device
ankle brace with vibrator that provides electric stimulus

Experimental: PD patients 1
PD patients with freezing of gait
Device: vibratory cueing device
ankle brace with vibrator that provides electric stimulus

Experimental: Healthy Volunteers
Age and gender matched healthy volunteers.
Device: Mobile Gait Trainer
standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps




Primary Outcome Measures :
  1. 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. [ Time Frame: ongoing ]
  2. Changes in Stride length [ Time Frame: ongoing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416452


Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Shabbir Hussain I Merchant, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT03416452     History of Changes
Other Study ID Numbers: 180050
18-N-0050
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: January 24, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Gait
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases