Image-Guided DBS Programming for Essential Tremor

GR
Overseen ByGabriella R Maze, BS
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to compare the effects of image-guided programming algorithm using various image segmentations vs standard clinical programming on reduction of tremor and patient satisfaction.

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Programming and Assessment

Participants undergo baseline tremor assessment and initial programming with either image-guided or clinical-based settings.

1 day
1 visit (in-person)

Treatment

Participants switch between Program A and Program B settings, followed by a preference period.

4 weeks
2 phone calls, 1 visit (in-person)

Follow-up

Participants are monitored for outcomes of programming optimization, including tremor assessments and quality of life evaluations.

1 month
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Image-Guided DBS Programming

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Program BExperimental Treatment1 Intervention
Group II: Program AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+