Dual Frequency Stimulation in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals who are 18 years and older
Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months
Individuals diagnosed with advanced PD who had bilateral dorsal subthalamic nucleus DBS surgery, as standard of care for motor improvement, with distal contacts of the electrodes implanted into the ventral STN
Disqualifiers
Individuals unable to provide consent and/or lack capacity to consent
Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
Individuals who score below 15 on the Montreal Cognitive Assessment Test-Blind
Individuals who score above 20 on the Center for Epidemiologic Studies Depression Scale
Trial design
Design model
Single group
Treatments tested in this trial
Deep brain stimulation
DevicePatients with idiopathic Parkinson's disease who have previously been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months. These patients will already be receiving high-frequency dorsal STN stimulation as part of the standard of care for PD. Once patients have provided consent and are enrolled in this study, they will receive simultaneous low-frequency stimulation of the ventral STN to examine if there are any effects on cognitive performance.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Sustained Dual Frequency, Dual Region, StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Time frame
Baseline, Week 2, Week 6, Month 3, and Month 62
Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11)
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.
Time frame
Baseline, Week 2, Week 6, Month 3, and Month 63
Mean Change from Baseline in Neuropsychiatric Inventory (NPI)
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.
Time frame
Baseline, Week 2, Week 6, Month 3, and Month 64
Mean Change from Baseline in Movement Scores on Part III of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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.
Time frame
Baseline, Week 2, Week 6, Month 3, and Month 6Secondary outcomes
1
Mean Change from Baseline in Decision-Making Scores on Probabilistic Gambling Task
A patient-specific measure of risk attitude during a gambling task. We will estimate indifference points (win probability at which risky choice is chosen 50% of the time) at each time point and compare to those points during baseline performance on the task.
Time frame
Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 62
Mean Change from Baseline in Inter-Temporal Choice Scores on a Temporal Discounting Task
A patient-specific measure of risk attitude during a temporal preferences task. We will examine the area under the curve of the empirical discount functions of 'larger later' rewards and 'smaller sooner' rewards. Smaller values indicate increased preference for smaller sooner over larger later rewards. Scores will be compared to baseline performance on the task.
Time frame
Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 63
Mean Change from Baseline in Verbal Fluency Scores on Word Generation Task
The average number of words generated in a 1-minute time frame.
Time frame
Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6Sponsors and contacts
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Source ClinicalTrials.gov