Gait Disorders in Parkinson's Disease

Lead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Source

National Institutes of Health Clinical Center (CC)

Oversight Info

Is Fda Regulated Drug

Is Fda Regulated Device

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

Parkinson's Disease

Intervention

Intervention Type

Device

Intervention Name

vibratory cueing device

Description

ankle brace with vibrator that provides electric stimulus

Arm Group Label

PD patients 1

PD patients

Intervention Type

Device

Intervention Name

Mobile Gait Trainer

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

Gait

, Parkinson's Disease

Has Expanded Access

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.

ICH GCP | Clinical Trials Registry