Recruiting

Dual Frequency Stimulation

Sponsor:

UCLA

Code:

NCT04650932

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation

Study Details

Brief summary:

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.

Conditions

Parkinson Disease

Study ID

NCT04650932

Start date

Oct 22, 2022

Status verified date

Mar, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pregnant women (note: pregnant women are not candidates for DBS surgery), and prisoners
  • Non-English speaking individuals. Cognitive tasks will only be conducted in English.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sustained Dual Frequency, Dual Region, Stimulation

Interventions

Deep brain stimulation

Patients 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.

Primary outcome measure

  • Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]
  • Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]
  • Mean Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]
  • Mean Change from Baseline in Movement Scores on Part III of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]
  • Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA) [ Time Frame: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5 ]
  • Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10) [ Time Frame: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5 ]
  • Mean Change from Baseline in Motor and Non-Motor Aspects of Daily Living Scores on Parts I and II of the MDS-UPDRS [ Time Frame: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5 ]

Central Contacts and Locations

Central contacts

Kiarash Shahlaie, MD, PhD

916-703-5505krshahlaie@ucdavis.edu

Janice Wang-Polagruto, PhD, CCRP

916-551-3244jfwang@ucdavis.edu

Locations

UC Davis Health

Recruiting

Sacramento, California, United States, 95817

Contacts

Jessica Beatty, MS

916-734-0901jabeatty@ucdavis.edu

Janice Wang-Polagruto, PhD, CCRP

916-551-3244jfwang@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • DBS
  • Deep Brain Stimulation
  • STN
  • Subthalamic Nucleus
  • Parkinson disease
  • Dual frequency
  • Dual region
  • DFDR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-03-31.