search
Back to results

Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients (PC+S_PFC)

Primary Purpose

Parkinson's Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activa PC+S Prefrontal
Sponsored by
Simon J. Little, MBBS, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF Surgical Movement Disorders Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD with mood disorder or impulsivity

Arm Description

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.

Outcomes

Primary Outcome Measures

Level of reduction in Anxiety in Parkinson's Disease patients treated with cortical stimulation
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
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
The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP) will be used to assess impulsivity.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2016
Last Updated
July 20, 2023
Sponsor
Simon J. Little, MBBS, PhD
search

1. Study Identification

Unique Protocol Identification Number
NCT03131817
Brief Title
Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients
Acronym
PC+S_PFC
Official Title
Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2016 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Simon J. Little, MBBS, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD with mood disorder or impulsivity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Activa PC+S Prefrontal
Primary Outcome Measure Information:
Title
Level of reduction in Anxiety in Parkinson's Disease patients treated with cortical stimulation
Description
The Parkinson Anxiety Scale (PAS) will be used to assess anxiety.
Time Frame
24 months
Title
Level of reduction in Depression in Parkinson's Disease patients treated with cortical stimulation
Description
The Hospital Anxiety and Depression scale (HADS) will be used to assess depression.
Time Frame
24 months
Title
Level of reduction in Impulsivity in Parkinson's Disease patients treated with cortical stimulation
Description
The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP) will be used to assess impulsivity.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: depression (BDI>=13) anxiety (BAI >=7) 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Little, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Surgical Movement Disorders Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients

We'll reach out to this number within 24 hrs