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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 : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Philip Starr, University of California, San Francisco

Brief Summary:
This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Activa PC+S Prefrontal Not Applicable

Detailed Description:

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 Activa PC+S pulse generator (Medtronic), an investigational device 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. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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, 2020
Estimated Study Completion Date : December 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to give informed consent for the study
  • Age 30-75
  • Diagnosis of Parkinson's disease by a movement disorders specialist
  • Movement disorder symptoms that are sufficiently severe, in the setting of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
  • UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.

OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management OR Patients intolerant to medication causing significant functional disability

  • Have one or several mild to moderate mood or impulsive behavior as defined by:

    1. depression (BDI>=13)
    2. anxiety (BAI >=7)
    3. impulsive behavior as indicated by a positive score on the QUIP-A (Questionnaire for Impulsive-Compulsive disorders in Parkinson's Disease) or as determined by clinical interview or informant report
    4. Mood or behavior symptom fluctuations corresponding to minimum 30% improvement in non-motor symptoms when comparing visual analogue scales (VAS) scores in the on versus off medication state
  • Stable doses of anti-Parkinsonian medications for at least 30 days prior to their baseline assessment.

Exclusion Criteria:

  • Pregnancy or breast feeding
  • MRI showing cortical atrophy out of proportion to age
  • MRI showing focal brain lesions that could indicate a disorder other than idiopathic PD
  • Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
  • Any prior intracranial surgery except DBS surgery
  • Significant cognitive impairment (MoCA<20).
  • History of seizures
  • Immunocompromised
  • Has an active infection
  • Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
  • Inability to comply with study follow-up visits
  • Any personality or mood symptoms that study personnel believe will interfere with study requirements.

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): NCT03131817


Locations
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United States, California
UCSF Surgical Movement Disorders Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco

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Responsible Party: Philip Starr, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03131817     History of Changes
Other Study ID Numbers: 16-20284
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Behavioral Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases