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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: Summit RC+S | Experimental |
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| Device: Percept PC | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Loop DBS | Device | Standard DBS therapy at a constant frequency and voltage |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to Stimulation Condition | A Customized Adverse Events and Tolerability Questionnaire will measure the absence/presence and frequency of paresthesias, and muscle twitching relative to each stimulation condition | 3 Months |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to quality of life | 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 Months |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to speech | The Speech Intelligibility Test (SIT) will measure changes in speech related to each stimulation condition. | 6 Months |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to gait | The Freezing of Gait Questionnaire (FOG-Q) will be used to record changes in gait over time | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Parameters: Arrhythmicity | Variability in stride time during a gait task | Collected up to 10 days every 3 months |
| Gait Parameters: Mean Shank Angular Velocity | Average of the peak shank angular velocities of every stride during the gait task |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen M. Bronte-Stewart, MD,MSE | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2020 | Oct 10, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Participants will have either the Percept PC system, or Summit RC+S system from Medtronic PLC implanted.
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| 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 |
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| 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. |
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| Collected up to 10 days every 3 months |
| Gait Parameters: Mean Gait Cycle Time | Average length of time of each stride during a gait task | Collected up to 10 days every 3 months |
| Percent Time Freezing | The percentage of the gait task was a participant frozen | Collected up to 10 days every 3 months |
| The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | 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. | Collected up to 10 days every 3 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |