Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery

NCT ID: NCT01705301

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-07-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, the investigators will monitor extracellular neurotransmitter levels using a probe that is able to perform real time electrochemical detection during deep brain stimulation surgery. The overall question this study is designed to answer is: Are there neurotransmitters released during deep brain stimulation?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, the investigators will monitor extracellular neurotransmitter levels using a probe that is able to perform realtime electrochemical detection during DBS neurosurgery. The overall question this study is designed to answer is: Are there neurotransmitters released during deep brain stimulation? We propose to enroll 45 patients (15 patients each at the three targets for DBS) with Essential Tremor, Parkinson's Disease, and Dystonia who are undergoing DBS neurosurgery. This will be an acute study. Patients with medically identifiable symptoms of the above diseases who have been approved by Mayo DBS committee for implantation of DBS will be selected for this study. These patients will then be consented preoperatively to undergo extracellular electrophysiology which is typical in these cases to determine the target site for implantation of the DBS electrodes. Following this electrophysiologic procedure, the patient will have electrochemical electrode implanted to (1) determine whether there is adenosine release at the site of stimulation during ventral intermediate nucleus (VIM) thalamic DBS, (2) determine whether there is dopamine and adenosine release within the caudate nucleus or putamen during subthalamic nucleus DBS, and (3) determine whether there is dopamine and adenosine release at the site of stimulation during Globus Pallidus DBS.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Tremor Parkinson's Disease Dystonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Deep Brain Stimulation

Patient's undergoing the clinical procedure of Deep Brain Stimulation will have the experimental protocol that involves, after implantation of the DBS electrodes, a single electrochemical recording electrode, from the WINCS system, implanted along the same trajectory path as the electrophysiology and the DBS electrode

WINCS

Intervention Type DEVICE

The experimental protocol will involve, after implantation of the DBS electrodes, the patient will have a single electrochemical recording electrode will be implanted along the same trajectory path as the electrophysiology and the DBS electrode

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WINCS

The experimental protocol will involve, after implantation of the DBS electrodes, the patient will have a single electrochemical recording electrode will be implanted along the same trajectory path as the electrophysiology and the DBS electrode

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult Patients with medically intractable Essential Tremor, Parkinson's Disease, and Dystonia who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.

Exclusion Criteria

* pregnant patients,
* prisoners,
* children (age less than 18), and
* any patients identified as unsuitable for these protocol by the Mayo DBS committee.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kendall H. Lee

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kendall Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Bennet KE, Tomshine JR, Min HK, Manciu FS, Marsh MP, Paek SB, Settell ML, Nicolai EN, Blaha CD, Kouzani AZ, Chang SY, Lee KH. A Diamond-Based Electrode for Detection of Neurochemicals in the Human Brain. Front Hum Neurosci. 2016 Mar 15;10:102. doi: 10.3389/fnhum.2016.00102. eCollection 2016.

Reference Type DERIVED
PMID: 27014033 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09-007441

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pulvinar Stimulation in Epilepsy: a Pilot Study
NCT04692701 ACTIVE_NOT_RECRUITING NA