Gait Disorders in Parkinson's Disease

November 19, 2018 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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.
Time Frame: ongoing
ongoing
Changes in Stride length
Time Frame: ongoing
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2018

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

November 13, 2018

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180050
  • 18-N-0050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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