Freezing of Gait: Clinical, Cognitive, and Imaging Features

NCT02387281 | Completed DMC

• 1 other identifier: IRB00073518
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Freezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD) and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting \<30 seconds) episode of absence or a greatly reduced forward movement of the feet despite intention to walk. It typically occurs when patients initiate gait (so-called "start hesitation") and when attempting to turn. It is a leading cause of falls and often results in a wheelchair-dependent state. FOG greatly interferes with activities of daily living, causes social isolation and poor quality of life. FOG is one of the least understood features of PD. It possibly may develop independent of the other motor features of the disease, and be caused by specific pathological changes in the brain. Previous studies on FOG have shown conflicting information and have not lead to clear understanding of the pathophysiology. One key reason for this is that there appears to be multiple subtypes which have rarely been taken into account. The purpose of this study is to show that different types of FOG exist and to see if there is a connection to cognitive differences or gait patterns.

Conditions

Parkinson Disease

Keywords

Freezing of gait

Outcome Measures

Primary Outcomes (4)

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III

  MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The Part III motor examination has 18 items, which are rated from 0-4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.

  Baseline

• Response to levodopa

  Subjects will be assessed in the "on" and "off" states to classify them properly according to pharmacological response to levodopa

  Baseline

• Classification of FOG using motion capture

  Classifying of FOG ("on" and "off") will be done measuring gait physiology though 3-dimensional motion capture between and during FOG episodes.

  Baseline

• Plasma concentrations of levodopa

  Levodopa plasma concentrations measured by modified high-performance liquid chromatography with electrochemical detection method during "on" and "off" episodes.

  Baseline

Secondary Outcomes (25)

• Dot Counting task score

  Baseline

• N-back task score

  Baseline

• Flanker task score

  Baseline

• Dimensional Set Shifting task score

  Baseline

• Digit Span Test score

  Baseline

Study Arms (4)

PD with FOG "on"

Subjects diagnosed with Parkinson disease (PD) and sub-categorized as "on" freezing of gait (FOG) based on evaluation using motion capture

PD with FOG "off"

Subjects diagnosed with Parkinson disease (PD) and sub-categorized as "off" freezing of gait (FOG) based on evaluation using motion capture

PD without FOG

Subjects with Parkinson disease (PD) and an absence of freezing of gait (FOG)

Non-PD with FOG

Subjects with freezing of gait (FOG) and an absence of Parkinson disease (PD) (exception granted for those with FOG and atypical parkinsonism: PSP or MSA)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Freezing of gait (FOG) patients with Parkinson disease (PD) will be selected from the Emory Movement Disorders Center.

You may qualify if:

• Diagnosis of PD by United Kingdom Brain bank criteria
• Hoehn \& Yahr stage I-IV
• Levodopa treated and responsive
• Able to manage 12 hours off dopaminergic medication
• Age 18-85 years
• Presence of FOG by history and seen by examiner at their clinical office visit or in a video taken at home
• Able sign a consent document and willing to participate in all aspects of the study
• Able to have an MRI scan (no pacemakers or history of claustrophobia)

You may not qualify if:

• Dementia that precludes completing study protocol
• Stage V PD - unable to walk independently when "off"
• History of FOG without ever being seen to have it
• Atypical parkinsonism: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD), Vascular Parkinsonism
• Treatment with medications that cause parkinsonism: drug-induced parkinsonism
• Any neurological or orthopedic disorders that interfere with gait
• Treatment with medications that will interfere with NET-PET (norepinephrine transporter-positron emission tomography) ligand binding
• a. Noradrenergic drugs: methylphenidate, atomoxetine, serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine)
• Absence or loss of levodopa response
• Any contraindications for MRI scan including pacemaker, deep brain stimulator, bladder stimulator, etc.
• Diagnosis of PD by United Kingdom Brain bank criteria
• Hoehn \& Yahr stage I-IV
• Levodopa treated and responsive
• Able to manage 12 hours off dopaminergic medication
• Age 18-85 years, age, gender and duration matched to the PD with FOG recruits

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory Movement Disorders Center

Atlanta, Georgia, 30329, United States

Location

Wesley Woods Center

Atlanta, Georgia, 30329, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Stewart Factor, DO

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 12, 2015
• Study Start: March 1, 2015
• Primary Completion: November 13, 2017
• Study Completion: November 13, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

US (2)