Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor

Purpose

The purpose of this research study is to test the effectiveness and safety of Responsive Deep Brain Stimulation (R-DBS) for Essential Tremor (ET). Current DBS therapy for ET leaves the device on all of the time, even when you do not have tremor.

With R-DBS, the device will only turn on when you make certain movements that lead to tremor. Continuous DBS can lead to undesirable side effects such as stuttering, walking/balance problems. R-DBS will turn on only in response to a signal in your brain prior to and during tremor, and therefore the DBS will not be on all of the time.

The device actually has the potential to see a brain signal change associated with your tremor less than a second before the tremor occurs. We hope that R-DBS will provide the same benefit with fewer side effects. We believe that R-DBS may also prolong the battery life of your implant.

Procedures

  • Because you are in the study, you have already decided and been approved to have DBS surgery.
  • As part of your study participation, prior to the insertion of the DBS wires, the surgeon will insert an additional 4-contact paddle lead (Model 09130 Subdural Quadripolar Paddle Lead) into the same burr hole as the DBS lead. This strip will lie on the top of your brain and will be placed in a position where tremor signals are detected. During the procedure to place the investigational strip, we will record additional measurements of your brain’s activity.
  • You will come back about a month later to have the battery placed in your chest, under general anesthesia, that will control the stimulation produced by the lead. The brain sensor allows the research team to evaluate brain activity that may be related to your tremor, and the lead provides stimulation to hopefully reduce frequency and severity of your tremor.
  • You will return to our clinic monthly for 3-4 consecutive days at a time for the first 6 months to find your optimal stimulation parameters and for the research team to download your brain activity captured by the sensors. Ideally, the downloaded brain activity will work with stimulation to more efficiently capture your tremor. After this 6 month period, you will return every 3-6 months for similar 3-4 day visits to check and reprogram the devices as necessary, until Month 24.
  • The length of your participation will be 24 months.

Eligibility

  • Diagnosis of Essential Tremor for at least 3 years.
  • Significant disabling, medication-refractory upper extremity tremor for at least 3 months prior to implantation.

For additional study details about eligibility and procedures, please contact Kyle Rizer: 

Age

18 to 65
65 and over

Gender

Male
Female

Monetary compensation

No

Can be done from home

No

Keywords

Tremor, Tremors, Essential tremor, Essential tremors, Neurology

Principal Investigator

Aysegul Gunduz, PhD

Department

Neurology

Contact Information

kyle.rizer@neurology.ufl.edu

352-733-2426


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