A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease

NCT02318927 | Completed DMC FDA Device

• 1 other identifier: IRB201400951
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these two brain regions after surgery will allow for the development of a personalized DBS system to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the optimized device settings.

Conditions

Parkinsons Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Number of Freezing of Gait (FoG) episodes in the laboratory during the FoG battery

  Change from Baseline to 6 Months

Secondary Outcomes (1)

• Number of adverse events (AE's) .

  Change from Baseline to 24 Months

Other Outcomes (8)

• Freezing of gait questionnaire

  Change from Baseline to 6 Months

• Gait and falls questionnaire

  Change from Baseline to 6 Months

• Activities/balance confidence scale

  Change from Baseline to 6 Months

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.

Deep Brain Stimulation

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
• Must be deemed appropriate for a GPi DBS operation by the interdisciplinary screening team (GPi must be the target chosen as most appropriate for treatment of their PD to qualify for this study)
• Age 30-75 years (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). 5. 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. 8. 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. 5. 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. 8. Subjects who may require repeat MRI scans. 9. Subjects with a history of a cranial neurosurgical procedure. 10. 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
• Medtronic: collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

University of Florida Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

Related Publications (2)

• Molina R, Hass CJ, Sowalsky K, Schmitt AC, Opri E, Roper JA, Martinez-Ramirez D, Hess CW, Foote KD, Okun MS, Gunduz A. Neurophysiological Correlates of Gait in the Human Basal Ganglia and the PPN Region in Parkinson's Disease. Front Hum Neurosci. 2020 Jun 4;14:194. doi: 10.3389/fnhum.2020.00194. eCollection 2020.

  PMID: 32581744 DERIVED

• Tahafchi P, Molina R, Roper JA, Sowalsky K, Hass CJ, Gunduz A, Okun MS, Judy JW. Freezing-of-Gait detection using temporal, spatial, and physiological features with a support-vector-machine classifier. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:2867-2870. doi: 10.1109/EMBC.2017.8037455.

  PMID: 29060496 DERIVED

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

• Michael S Okun, MD

  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: December 12, 2014
• First Posted: December 17, 2014
• Study Start: January 1, 2015
• Primary Completion: November 3, 2016
• Study Completion: September 26, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

US (1)