Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04043403|
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : October 18, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
- 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.
- 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
- 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.
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||25 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Contact: Helen Bronte-Stewart, MD MSEemail@example.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Sudeep Aditham 650-723-6709 firstname.lastname@example.org|
|Principal Investigator: Helen M Bronte-Stewart, MD MSE|
|Principal Investigator:||Helen M. Bronte-Stewart, MD,MSE||Stanford University|
|Responsible Party:||Helen M. Bronte-Stewart, Principal Investigator, Stanford University|
|Other Study ID Numbers:||
|First Posted:||August 2, 2019 Key Record Dates|
|Last Update Posted:||October 18, 2022|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases