Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients (PC+S_PFC)
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|ClinicalTrials.gov Identifier: NCT03131817|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Activa PC+S Prefrontal||Not Applicable|
Depression, anxiety and impulse control disorders are among the most prominent neuropsychiatric symptoms in Parkinson's disease (PD) that greatly impact patients' and caregivers' quality of life. However, the neural correlate underlying these symptoms is still largely unknown preventing the development of comprehensive treatment for these symptoms.
The aims of this study are to 1) Determine the neural correlates of non-motor symptoms, 2) Determine how cortical stimulation can reduce these symptoms and normalize the abnormal brain signals, 3) Develop closed-loop stimulation paradigms and 4) Teach patients how to voluntarily modulate the abnormal brain signals.
Ten PD patients undergoing deep brain surgery (DBS) implantation and diagnosed with mild to moderate mood disorder and/or impulsive behavior will be enrolled in this study. In addition to the standard therapeutic DBS electrode used to treat motor symptoms, a flexible electrode will be placed over the prefrontal cortex. Both electrodes will be attached to the Medtronic Activa PC+S pulse generator (and Medtronic Summit RC+S pulse generator as replacements), investigational devices that allows therapeutic stimulation and chronic brain recordings. At multiple time points, up to 2 years post-implantation, in our clinic or patient's home, brain signals will be recorded while patients are resting or performing emotion/cognition tasks. Symptoms will be assessed using validated questionnaires and tasks to allow identification of neurophysiological correlates of non-motor symptoms. There is also an optional sleep study included for better understanding of the brain's physiology. The investigators will then investigate the effect of cortical stimulation on both symptoms severity and brain signals that may be related to symptom expression. These signals will then be used to implement closed-loop controlled cortical stimulation and neuro-feedback controlled strategies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's|
|Actual Study Start Date :||December 16, 2016|
|Estimated Primary Completion Date :||December 16, 2021|
|Estimated Study Completion Date :||December 16, 2022|
Experimental: PD with mood disorder or impulsivity
This is a single-center study of the neurophysiology of non-motor symptoms such as anxiety, depression, and impulsivity that are comorbid in Parkinson's Disease.
Device: Activa PC+S Prefrontal
- Level of reduction in Anxiety in Parkinson's Disease patients treated with cortical stimulation [ Time Frame: 24 months ]The Parkinson Anxiety Scale (PAS) will be used to assess anxiety.
- Level of reduction in Depression in Parkinson's Disease patients treated with cortical stimulation [ Time Frame: 24 months ]The Hospital Anxiety and Depression scale (HADS) will be used to assess depression.
- Level of reduction in Impulsivity in Parkinson's Disease patients treated with cortical stimulation [ Time Frame: 24 months ]The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP) will be used to assess impulsivity.
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): NCT03131817
|United States, California|
|UCSF Surgical Movement Disorders Center|
|San Francisco, California, United States, 94115|