DBS Programming for Essential Tremor

N/A

Recruiting

Research Sponsored by Alfonso Fasano

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 2-baseline, month 2, month 4, month 6, month 8

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to recruit 5 to 10 patients who have tremors and previously had VIM-DBS treatment but lost its benefits, as well as 10 patients with essential tremor who

Who is the study for?

This trial is for patients with tremors, specifically those who have had VIM-DBS treatment but lost its benefits and those needing new VIM-DBS surgery. Up to 20 people will be enrolled, all of whom must have essential tremor and agree to receive a specific device implant.

What is being tested?

The study tests a DBS programming method using the Chronos software in two phases: first, finding the best stimulation pattern for tremor control; second, evaluating safety and effectiveness of this approach in new patients requiring bilateral VIM deep brain stimulation.

What are the potential side effects?

While not explicitly listed here, side effects may include typical risks associated with deep brain stimulation such as infection at the surgical site, headache or discomfort from the device, speech problems, balance issues or unwanted muscle contractions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 2-baseline, month 2, month 4, month 6, month 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase 2-baseline, month 2, month 4, month 6, month 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 2-baseline, month 2, month 4, month 6, month 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Base of support (meter)

Gait speed (meter per second)

Posturography (newtons)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 Intervention

Ten patients with ET needing DBS-VIM surgery will be recruited and will receive Boston Scientific Genus IPG bilaterally connected to Boston Scientific Cartesia™ 8-contact Directional Leads. The programming will be done in four different settings/periods during the course of 8 months.

Group II: Phase 1Experimental Treatment1 Intervention

5 to 10 patients with tremor already treated with VIM-DBS but not doing well because of early or late loss of benefits will be recruited by the PI over a 6 months period. If interested, the potential participants will be screened, informed, and consented by a research coordinator. Before the replacement of their IPG (implantable pulse generator), a baseline measurement will be performed.

Do I qualify?Apply below to find out