NCT02731365

Brief Summary

The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming. The data collected and LFP markers identified will serve as guidelines for future stimulation predicted programming.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

October 13, 2015

Last Update Submit

November 16, 2016

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Identify and record LFP

    The association between local field potential (LFP) signals in individuals who have undergone deep brain stimulation (DBS) of the subthalamic nucleus (STN) and successful completion of a cursor drive motor task.

    18 months

Study Arms (1)

DBS LFP Activa PC+S

EXPERIMENTAL

The study aims at testing a slightly modified device (battery) that is similar to the approved system that has the potential of offering future patients a closed loop system with automatic adjustments of stimulation. The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming.

Device: Activa PC+S

Interventions

Activa PC+SDEVICE

The Activa PC+S is a newly developed Medtronic DBS implantable system and is available for use in clinical research. This system has a mechanism for both sensing of LFP and the ability to provide deep brain stimulation therapy. The sensing capabilities are controllable with data management using a clinician sensing tablet programmer that has a USB extension allowing for telemetry to an encrypted, locked computer.

DBS LFP Activa PC+S

Eligibility Criteria

Age22 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who are candidates for DBS surgery.
  • Age 22-90 years of age
  • Participant is willing to comply with all follow-up evaluations at the specified study time points.
  • Participant is able to provide informed consent prior to enrollment in the study.
  • The participant is fluent in English.

You may not qualify if:

  • Significant cognitive impairment or dementia.
  • Uncontrolled depression, anxiety or other mood disorder.
  • Medical contraindications for general anesthesia, craniotomy, or DBS surgery.
  • Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
  • Condition requiring diathermy after DBS implantation.
  • Subjects with any type of destruction and/or damage to the STN as determined by brain imaging.
  • Co-morbid conditions that would interfere with study activities or response to treatment, which may include:
  • Life expectancy \< 3 years
  • Severe Chronic pulmonary disease
  • Intractable seizure disorders
  • Local, systemic acute or chronic infectious illness
  • Life threatening cardiac arrhythmias
  • Severe collagen vascular disorder
  • Kidney failure or other major organ systems failures
  • History of a neurological ablation procedure.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center - Center for Neuromodulation

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ali Rezai, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2015

First Posted

April 7, 2016

Study Start

February 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)