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Dual Frequency Stimulation in Parkinson's Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests low-frequency brain stimulation added to standard high-frequency deep brain stimulation (DBS) for Parkinson’s disease. It checks safety, side effects, and how well it works. It is for adults with advanced Parkinson’s disease who already have a specific DBS device.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have idiopathic Parkinson’s disease, meaning its cause is unknown.
  • Have had a Boston Scientific Vercise DBS system implanted for at least 3 months.
  • Have advanced Parkinson’s disease and had DBS surgery on both sides of the brain to improve movement. The wires must target the upper part of a brain area called the STN, with their tips in the lower part.

Who can't join

  • Cannot give informed consent, meaning you cannot understand and agree to take part.
  • Have thinking or physical problems that would limit your ability to do the thinking tests.
  • Score below 15 on the Montreal Cognitive Assessment Test-Blind, a test of thinking skills.
  • Score above 20 on the Center for Epidemiologic Studies Depression Scale, a test of depression symptoms.
  • Are pregnant.
  • Are a prisoner.
  • Do not speak English. The thinking tasks are only given in English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA