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Completed

NCT Number: NCT07213999

Novel DBS Device in Parkinson's Disease

The purpose of this research is to test a new recorder that can measure brain activity when stimulation is turned on during deep brain stimulation (DBS) surgery. To continue to improve DBS therapy, the investigators need to better understand the changes in the brain of people with Parkinson's disease (PD). They also need to know how this is affected by DBS. Current recorders measure activity immediately after, but not during, stimulation. Standard-of-care DBS already includes the electrical recording of brain activity during movement of arms and legs. These recordings occur during the microelectrode recording part of the surgery and are used by the medical team to determine where to place the DBS electrode.

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

About this study

Deep brain stimulation (DBS) is shown to be very effective in alleviating the motor symptoms of Parkinson's disease (PD). However, its exact mechanism is not well-understood. Clinical studies have reported conflicting results regarding the effects of DBS, with some studies suggesting that it inhibits target neurons while some others suggest that it excites those neurons. One of the significant hurdles plaguing the study of DBS is the large artifacts caused by electrical stimulation. The large artifacts saturate the neural recorder and also make it take a long time to recover to its normal working conditions. Consequently, no reliable neural feedback can be recorded during the high frequency stimulation of DBS. The investigators have developed a new neural recorder that does not saturate even in the presence of large artifacts. The recorder has been validated in animal studies and recently in human experiments. The investigators propose to further develop the device to study the mechanisms of DBS: in Aim 1, they will develop an artifact-resilient neural recorder and related software suite to support intraoperative monitoring during DBS. In Aim 2, they will use the proposed device to carry out an intraoperative electrophysiological recording of the subthalamic nucleus (STN) or globus pallidus internus (GPi) in PD patients. The investigators will compare activities of the neurons when high or low stimulation frequency is used, when stimulation is delivered ipsilaterally or contralaterally, and when different temporal patterns of DBS pulses are used. Measurements of therapeutic effects in terms of tremor power will be obtained by a wireless inertial measurement unit. The investigators will correlate tremor power, neural responses, and stimulation parameters during DBS, which can provide new insights into the mechanisms of DBS. These insights can potentially lead to a better stimulation paradigm that can enhance the efficacy of DBS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has unilateral STN or GPi DBS and is approved to undergo second or contralateral side implantation;
  • Diagnosis of idiopathic PD;
  • A history of a good response to levodopa (carbidopa/levodopa) defined as at least a 30% improvement in motor unified Parkinson's disease rating scale (UPDRS) score;
  • DBS surgery at UMN is planned as part of routine clinical care.

Exclusion criteria

  • Other significant neurological disorder
  • History of dementia
  • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
  • Pregnant women

Treatment and study plan

Novel neural recorder

Device

The neural recorder does not suffer saturation from stimulation artifacts, allowing circuits to record neural signals with higher precision.

Primary outcomes

  1. Wireless 9-axis inertial measurement unit (IMU) with 3-axis accelerometer, gyroscope, and magnetometer will quantitatively measure the activity of neurons when high or low stimulation frequency is used.

    Time frame: For the duration of the participant's' DBS surgery.

    The investigators will compare the activity of neurons when high or low stimulation frequency is used, when stimulation is delivered ipsilaterally or contralaterally, and when different temporal patterns of DBS pulses are used within the constraints of standard clinical practice.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Evaluating and Understanding the Effects of Deep Brain Stimulation Using Novel Electrophysiology Technique and Device in Parkinson's Disease

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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