Trial Outcomes & Findings for Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus (NCT NCT03600740)

Last Updated: 2021-04-29

Results Overview

Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

3 months

Results posted on

2021-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	GPi DBS Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue. DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GPi DBS Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue. DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
Overall Study Surgical plan was altered-subject not eligible	1

Baseline Characteristics

Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GPi DBS n=1 Participants Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue. DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 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	0 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	1 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
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Study was terminated due to delays in IRB approval and interval start of a competing study. Surgical plan was altered-subject not eligible. Data was not collected or analyzed.

Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data.

Outcome measures

Outcome data not reported

Adverse Events

GPi DBS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erik H. Middlebrooks, M.D.

Mayo Clinic

Phone: 904-953-6696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place