Uncovering an Electrical Biomarker for Freezing of Gait in Parkinson's Disease

NCT02548897 | Completed DMC FDA Device

• 1 other identifier: IRB201500458
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate brain signals related to freezing of gait (FoG), a symptom of Parkinson's Disease, that can lead to dangerous falls. The investigators hypothesize that uncovering these signals can lead to better deep brain stimulation interventions.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease with Freezing of Gait Symptoms

Outcome Measures

Primary Outcomes (1)

• Number of freezing of gait events

  up to months 24 post DBS surgery

Study Arms (1)

Freezing of gait in PD

EXPERIMENTAL

All participants will undergo an deep brain stimulation (DBS) for the FOG, and an electroencephalography (EEG) to better understand the neurophysiological underpinnings of the symptom. In addition, review changes in scalp recorded EEG and gait parameters during natural FoG episodes while participants are ambulatory in an advanced gait laboratory setting using a wireless EEG amplifier with active electrodes.

Device: Deep brain stimulation; Other: Electroencephalography

Interventions

Deep brain stimulation DEVICE

The programming of DBS settings in all participants with bilateral DBS implants in the globus pallidus internus (GPi) and pedunculopontine nucleus (PPN) will be performed.

Also known as: DBS

Freezing of gait in PD

Electroencephalography OTHER

An electroencephalography (EEG) will be performed on all participants to better understand the neurophysiological underpinnings of the symptom.

Also known as: EEG

Freezing of gait in PD

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of idiopathic PD, without a previous DBS operation and must be deemed appropriate for a DBS operation by the interdisciplinary screening team (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).
• Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state).
• Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.
• Patients must possess a clinical history of gait freezing \> 2 episodes per month, to be included, participants must also score \> 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.
• L-dopa responsive with clearly defined "on" periods.
• Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

You may not qualify if:

• Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
• Evidence of secondary or atypical parkinsonism.
• Other neurological and musculoskeletal impairments that would negatively influence postural stability
• Past MRI scan with significant evidence of brain atrophy or other abnormalities.
• Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score \<130.
• A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score \>14.
• Subjects with a history of seizures.
• Subjects who may require repeat MRI scans.
• Subjects with a history of a cranial neurosurgical procedure.
• Subjects with metal in the head or another implanted stimulator (e.g. vagus nerve stimulator, spinal cord stimulator, pacemaker, cochlear implant, etc).
• Subjects who require treatment with Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS).
• Pregnant or nursing women or women who wish to become pregnant will be excluded.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Aysegul Gunduz, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 14, 2015
• Study Start: October 1, 2015
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (1)