Scalar Closed Loop Intraoperative Study

NCT03270657 | Completed Results DMC FDA Device

• 2 other identifiers: Pro00085076UH3NS103468
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure neural activity during deep brain stimulation (DBS). There are two types of neural activity that we will record from DBS electrodes during this study: DBS local evoked potentials (DLEPs) and spontaneous, local field potentials (LFPs). We will measure the effects of varying stimulation parameters on both the neural activity and changes in motor symptoms -- bradykinesia and tremor -- in subjects with Parkinson's disease (PD). Correlating neural activity characteristics with changes in symptoms will improve our understanding of the mechanisms of action of DBS. This intraoperative study will specifically compare our ability to record neural activity using circuitry developed at Duke for this purpose \[Kent et al, 2015\] to a new, implanted pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S (that is not designed for implantation), and will lead to a clinical trial assessing the efficacy of the implantable RC+S IPG in PD patients once this device is available and approved for this trial.

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recorded Evoked Neural Signals From Deep Brain Stimulation (DBS) Electrodes During DBS for Parkinson's Disease.

  Measured by the ability to record neural activity through DBS electrodes using circuitry developed at Duke for this purpose and/or a new implantable pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S that is not designed for implantation.

  End of procedure, approximately 45 minutes

Secondary Outcomes (2)

• Number of Participants With Recorded DBS Local Evoked Potentials (DLEPs).

  End of procedure, approximately 45 minutes

• Number of Participants With Recorded Spontaneous, Local Field Potentials (LFPs).

  End of procedure, approximately 45 minutes

Study Arms (1)

Intraoperative Recording During DBS Implant Surgery

OTHER

Participants will be recruited and enrolled from individuals who have Parkinson's disease (PD) and who already are scheduled to undergo the planned deep brain electrode placement for treatment of their movement disorder. Intraoperative recordings of participants' neural signals will be made through the implanted deep brain electrode(s).

Device: IPG; RC+S

Interventions

IPG; RC+S DEVICE

We will measure the effects of varying stimulation parameters on the neural activity in subjects with Parkinson's disease (PD).

Intraoperative Recording During DBS Implant Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease (PD) patients who are scheduled to already undergo the planned deep brain electrode placement for treatment of their movement disorder at Duke University Medical Center.
• Able to understand the study and consent form, and interested in proceeding with research during the invasive brain surgery to receive a DBS system for treatment of PD.

You may not qualify if:

• Inability to execute the motor tasks during the study.

Sponsors & Collaborators

• Dennis Turner, M.D.: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Dennis Turner
• Organization: Duke University

dennis.turner@duke.edu

919-684-7777

Study Officials

• Dennis Turner, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurosurgery, Neurosurgery

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 1, 2017
• Study Start: April 5, 2018
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)