Novel DBS Device in Parkinson's Disease

NCT ID: NCT07213999

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-07-02

Brief Summary

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.

Detailed Description

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.

Conditions

Parkinson's Disease (PD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neural recorder

Group Type: EXPERIMENTAL

Novel neural recorder

Intervention Type: DEVICE

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

Interventions

Novel neural recorder

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Countries

United States

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Related Links

https://reporter.nih.gov/project-details/9722638

Related Info

Other Identifiers

R21NS111214-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005478

Identifier Type: -

Identifier Source: org_study_id