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Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback

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ClinicalTrials.gov Identifier: NCT04043403
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : October 18, 2022
Sponsor:
Information provided by (Responsible Party):
Helen M. Bronte-Stewart, Stanford University

Study Description
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Brief Summary:

Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop fashion that does not respond to a patient's current state. Although gait deficits and freezing of gait may initially respond to continuous open-loop deep brain stimulation (olDBS) and medication, the symptoms often recur over time.

The episodic and predictable nature of FOG makes it well suited for adaptive DBS (aDBS) and a device that overcomes the limitations of traditional high frequency olDBS and is capable of adapting therapy either in the frequency or intensity domain transiently to treat FOG while also treating other PD signs such as tremor and bradykinesia.

The purpose of this study is to determine the feasibility of an adaptive DBS system, that responds to patient-specific neural and kinematic variables with customized DBS parameters.


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Open Loop DBS (Summit RC+S) Device: Adaptive (Closed Loop) DBS (Summit RC+S) Device: Intermittent Open Loop DBS (Summit RC+S) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Device: Open Loop DBS (Summit RC+S)
    Standard DBS therapy at a constant frequency and voltage
  • Device: Adaptive (Closed Loop) DBS (Summit RC+S)
    DBS that responds to neural or kinematic features of patient's current state
  • Device: Intermittent Open Loop DBS (Summit RC+S)
    Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.

Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to Stimulation Condition [ Time Frame: 5 years ]
    A Customized Adverse Events and Tolerability Questionnaire will measure the absence/presence and frequency of paresthesias, and muscle twitching relative to each stimulation condition

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to quality of life [ Time Frame: 5 years ]

    The MDS-UPDRS Parts I, II, and IV will:

    (I) Evaluate mentation, behavior, and mood (II) Evaluate a patient's activities of daily life (IV) Measure the presence/severity of dyskinesias and other complications of therapy related to each stimulation condition.


  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to speech [ Time Frame: 5 years ]
    The Speech Intelligibility Test (SIT) will measure changes in speech related to each stimulation condition.

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to gait [ Time Frame: 5 years ]
    The Freezing of Gait Questionnaire (FOG-Q) will be used to record changes in gait related to each stimulation condition


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically-established PD
  • Meets criteria for STN DBS eligibility as part of patient's standard medical care
  • The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
  • Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
  • Age > 25
  • Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of MDS- UPDRS III ≥ 1

Exclusion Criteria:

  • Dementia
  • Untreated psychiatric disease
  • Hoehn and Yahr stage 5 on or off medication (non-ambulatory)
  • Age > 80
  • Major surgical morbidities such as severe hypertension, coagulopathy and certain metabolic conditions that might increase the risk of hemorrhage or other surgical complications
  • Presence of a cardiac pacemaker/defibrillator
  • Inability to understand/sign consent
  • Requires rTMS, ECT, MRI, or diathermy
  • Are pregnant or lactating
  • Has a cranial metallic implant
  • History of seizures or epilepsy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043403


Contacts
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Contact: Helen Bronte-Stewart, MD MSE 6507232116 bronte-stewart-lab@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Sudeep Aditham    650-723-6709    bronte-stewart-lab@stanford.edu   
Principal Investigator: Helen M Bronte-Stewart, MD MSE         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Helen M. Bronte-Stewart, MD,MSE Stanford University
More Information
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Responsible Party: Helen M. Bronte-Stewart, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT04043403    
Other Study ID Numbers: 52548
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases