Dual Frequency Stimulation in Parkinson's Disease
This study is looking at a new way to use Deep Brain Stimulation (DBS) with the Boston Scientific VerciseTM system for people with Parkinson's disease. DBS is a treatment where a device is implanted in the brain to send electrical signals. While DBS helps with movement problems, sometimes it can affect thinking skills. This study will explore if using "dual frequency stimulation" can improve issues like depression, impulsiveness, and other neuropsychiatric symptoms. You may be eligible if you are 18 or older, have Parkinson's disease, and have had the Boston Scientific VerciseTM DBS system implanted for at least 3 months. The study aims to enroll 10 participants.
- Study design
- This is an interventional study with an unknown phase, planning to enroll 10 participants. It focuses on how a specific DBS device affects symptoms.
- What's involved
- Your depression, impulsiveness, and neuropsychiatric symptoms will be measured at the start, then at Week 2, Week 6, Month 3, and Month 6.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after the study begins to track changes in their symptoms.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Dual Frequency Stimulation in Parkinson's Disease
At a glance
Conditions
NCT04650932
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
UC Davis Health
Sacramento, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Kiarash Shahlaie, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Davis
Who to contact
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Inclusion
Exclusion
What this trial measures
- Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)Baseline, Week 2, Week 6, Month 3, and Month 6
The score of the CES-D will be compared across sessions and a score that rises above 20 (out of 60) will be considered positive for the development of depression.
- Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11)Baseline, Week 2, Week 6, Month 3, and Month 6
The score of the BIS-11 will be evaluated across sessions and elevated scores indicate greater impulsivity and risk-taking behavior. The scale involves 30 questions with values from 1-4. Overall scores range from 30-120.
- Mean Change from Baseline in Neuropsychiatric Inventory (NPI)Baseline, Week 2, Week 6, Month 3, and Month 6
The NPI assesses frequency, change in severity, and distress over 12 neuropsychiatric domains as evaluated by the caregiver. We will look for a significant score reduction in any domain of the NPI.
- Mean Change from Baseline in Movement Scores on Part III of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)Baseline, Week 2, Week 6, Month 3, and Month 6
Part III of the MDS-UPDRS consists of 18 areas of motor assessments to assess severity of symptoms. Each score is rated in terms of severity from 0-4, with higher scores indicating higher severity of symptoms. A composite score will be evaluated for changes from baseline.
- Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA)Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5
This will be collected via telephone calls. The MoCA-Blind has been validated for telephone administration. We will re-evaluate MoCA-Blind scores during telephone monitoring to assess any changes to cognitive ability. A total score of less than 15 out of a possible 22 indicates greater than mild cognitive impairment.
- Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10)Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5
This will be collected via telephone calls. Patients will be given an unmarked form with questions and will be able to follow along the telephone conversation and answer each question (0-4 severity rating scale) for 10 questions focused on patient affect. A total score greater than 10 (out of 30) indicates the development of depression symptoms.
- Mean Change from Baseline in Motor and Non-Motor Aspects of Daily Living Scores on Parts I and II of the MDS-UPDRSBaseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5
This will be collected via telephone calls. Patients will be asked questions relating to motor and non-motor aspects of daily living and to rate the severity of their symptoms on a scale from 0-4, with higher scores indicating higher severity of symptoms. We will assess for changes in the composite score from baseline.