Trial Outcomes & Findings for Scalar Closed Loop Intraoperative Study (NCT NCT03270657)

Last Updated: 2020-03-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

End of procedure, approximately 45 minutes

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Intraoperative Recording During DBS Implant Surgery 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).
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intraoperative Recording During DBS Implant Surgery 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).
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Scalar Closed Loop Intraoperative Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intraoperative Recording During DBS Implant Surgery n=5 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: End of procedure, approximately 45 minutes

Outcome measures

Outcome measures
Measure	Intraoperative Recording During DBS Implant Surgery n=5 Participants 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).
Number of Participants With Recorded Evoked Neural Signals From Deep Brain Stimulation (DBS) Electrodes During DBS for Parkinson's Disease.	5 Participants

SECONDARY outcome

Timeframe: End of procedure, approximately 45 minutes

Measured by the ability to record DLEPs (changes in local electric field in response to DBS stimulation) 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. The DLEP recordings will be serially averaged with stimulus-triggering to remove random noise while preserving the evoked response.

Outcome measures

Outcome measures
Measure	Intraoperative Recording During DBS Implant Surgery n=5 Participants 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).
Number of Participants With Recorded DBS Local Evoked Potentials (DLEPs).	5 Participants

SECONDARY outcome

Timeframe: End of procedure, approximately 45 minutes

Measured by the ability to record LFPs (electrical activity in the local region of the DBS electrode) 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.

Outcome measures

Outcome measures
Measure	Intraoperative Recording During DBS Implant Surgery n=5 Participants 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).
Number of Participants With Recorded Spontaneous, Local Field Potentials (LFPs).	4 Participants

Adverse Events

Intraoperative Recording During DBS Implant Surgery

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intraoperative Recording During DBS Implant Surgery n=5 participants at risk 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).
Nervous system disorders somnolence	20.0% 1/5 • 30 days
Infections and infestations infection	20.0% 1/5 • 30 days

Other adverse events

Other adverse events
Measure	Intraoperative Recording During DBS Implant Surgery n=5 participants at risk 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).
Injury, poisoning and procedural complications hyperhidrosis	20.0% 1/5 • 30 days

Additional Information

Dr. Dennis Turner

Duke University

Phone: 919-684-7777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place