RECRUITING

Dual Frequency Stimulation in Parkinson's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

Quick Facts

Study Start:2022-10-22
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04650932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals who are 18 years and older
  2. * Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
  3. * Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months
  4. * 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
  1. * Individuals unable to provide consent and/or lack capacity to consent
  2. * Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
  3. * Individuals who score below 15 on the Montreal Cognitive Assessment Test-Blind
  4. * Individuals who score above 20 on the Center for Epidemiologic Studies Depression Scale
  5. * Pregnant women (note: pregnant women are not candidates for DBS surgery), and prisoners
  6. * Non-English speaking individuals. Cognitive tasks will only be conducted in English.

Contacts and Locations

Study Contact

Kiarash Shahlaie, MD, PhD
CONTACT
916-703-5505
krshahlaie@ucdavis.edu
Janice Wang-Polagruto, PhD, CCRP
CONTACT
916-551-3244
jfwang@ucdavis.edu

Principal Investigator

Kiarash Shahlaie, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

UC Davis Health
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Kiarash Shahlaie, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-22
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-10-22
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Parkinson Disease