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Completed

NCT Number: NCT04043403

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically-established PD
  • Meets criteria for STN DBS eligibility as part of patient's standard medical care or already implanted in the STN with Percept(TM) PC
  • 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 > 18
  • Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of MDS- UPDRS III ≥ 1
  • Greater than or equal to 1.2 microVp between 8-35 Hz on either the LSTN or RSTN (Percept (TM) PC cohort only)

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 (Summit(R) RC+S cohort only), or diathermy
  • Are pregnant or lactating
  • Has a cranial metallic implant
  • History of seizures or epilepsy

Treatment and study plan

Open Loop DBS

Device

Standard DBS therapy at a constant frequency and voltage

Adaptive (Closed Loop) DBS

Device

DBS that responds to neural (Percept PC and Summit RC+S) or kinematic (Summit RC+S) features of patient's current state

Intermittent Open Loop DBS

Device

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.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to Stimulation Condition

    Time frame: 3 Months

    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: 3 Months

    The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (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 over time

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to speech

    Time frame: 6 Months

    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: 3 Months

    The Freezing of Gait Questionnaire (FOG-Q) will be used to record changes in gait over time

Secondary outcomes

  1. Gait Parameters: Arrhythmicity

    Time frame: Collected up to 10 days every 3 months

    Variability in stride time during a gait task

  2. Gait Parameters: Mean Shank Angular Velocity

    Time frame: Collected up to 10 days every 3 months

    Average of the peak shank angular velocities of every stride during the gait task

  3. Gait Parameters: Mean Gait Cycle Time

    Time frame: Collected up to 10 days every 3 months

    Average length of time of each stride during a gait task

  4. Percent Time Freezing

    Time frame: Collected up to 10 days every 3 months

    The percentage of the gait task was a participant frozen

  5. The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III

    Time frame: Collected up to 10 days every 3 months

    Portion of the scale assesses the motor signs of PD. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2019
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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