Essential Tremor > Active Biphasic Pulse Stimulation---Home Settings

Brain Stimulation for Essential Tremor

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen By Leonardo B Almeida, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Florida

Disqualifiers: No essential tremor

No Placebo Group

Trial Summary

What is the purpose of this trial?

This project aims to investigate novel ways to deliver brain stimulation to Essential Tremor (ET) patients by introducing software changes to their existing devices. The study team aims to investigate safety and efficacy of these new stimulation parameters in patients with ET.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on brain stimulation for Essential Tremor, so it's best to ask the study team for guidance.

What data supports the effectiveness of the treatment for essential tremor?

Research shows that symmetric biphasic pulses can increase the therapeutic window (range of doses that are effective without causing side effects) in deep brain stimulation for essential tremor, potentially reducing side effects like ataxia (lack of muscle control). Shorter pulse widths may also help reduce side effects, although their long-term benefits need further study.

^{1 2 3 4 5}

Is brain stimulation for essential tremor generally safe?

Research suggests that using symmetric biphasic pulses in brain stimulation for essential tremor may reduce certain side effects compared to other pulse types. However, the long-term safety and effectiveness of these newer stimulation methods need further study.

^{1 2 4 5 6}

How is the treatment 'Active biphasic pulse stimulation' unique for essential tremor?

This treatment uses symmetric biphasic pulses, which can increase the therapeutic window (range of effective doses) and reduce side effects like ataxia (loss of control of body movements) compared to traditional methods. It offers a novel approach by modifying the pulse shape and width, potentially improving effectiveness and minimizing side effects.

^{1 2 4 7 8}

Eligibility Criteria

This trial is for people with Essential Tremor who already have a brain stimulation device implanted. They should be mentally sharp (with an MMSE score over 24) and have noticed their tremor control isn't as good as it was after surgery, even on two different check-ups.

Exclusion Criteria

I have not been diagnosed with Essential Tremor.

Participant Groups

The study tests new software settings for the brain stimulation devices in ET patients to see if they can better control tremors. Participants will try three modes: active stimulation at home, active VIN Biphasic stimulation, and periods with the stimulator turned off.

Group I: Patients with Essential Tremor Experimental Treatment 3 Interventions

Patients with chronically implanted DBS devices for ET who experience progressive worsening of tremor symptoms over time. The DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation. The following random conditions will be applied: (1) Home Settings; (2) VIN Biphasic; (3) Stimulator Off. A 30-minute washout period will be applied between each of the random conditions. Therefore, each patient will serve as their own control.

Active biphasic pulse stimulation---Home Settings is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Active biphasic pulse stimulation for:

• Essential Tremor

🇺🇸 Approved in United States as Biphasic DBS for:

• Essential Tremor
• Parkinson's Disease
• Dystonia

Find A Clinic Near You

Research locations nearby Select from list below to view details:

UF Health at the University of Florida Gainesville, FL

McKnight Brain Institute--Fixel Center for Neurological Diseases Gainesville, FL

Who is running the clinical trial?

University of Florida Lead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS) Collaborator

Medtronic Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Interphase Gaps in Symmetric Biphasic Pulses Reduce the Therapeutic Window in Ventral Intermediate Nucleus of the Thalamus-Deep Brain Stimulation for Essential Tremor. [2023] Symmetric biphasic pulses enlarge the therapeutic window in thalamic deep brain stimulation in patients with essential tremor. Adding an interphase gap to these symmetric biphasic pulses may further affect the therapeutic window.

2. England pubmed.ncbi.nlm.nih.gov

Acute stimulation with symmetric biphasic pulses induces less ataxia compared to cathodic pulses in DBS for essential tremor. [2023] Symmetric biphasic pulses have been shown to acutely increase the therapeutic window of ventralis intermedius deep brain stimulation (Vim-DBS) for essential tremor (ET) compared to cathodic pulses. Acute supratherapeutic stimulation can induce ataxic side effects in Vim-DBS.

3. United States pubmed.ncbi.nlm.nih.gov

Bipolar Directional Deep Brain Stimulation in Essential and Parkinsonian Tremor. [2022] To compare directional monopolar, bipolar, and directional bipolar thalamic deep brain stimulation (DBS) in tremor patients.

4. United States pubmed.ncbi.nlm.nih.gov

Less is more - Pulse width dependent therapeutic window in deep brain stimulation for essential tremor. [2019] Shorter pulse widths than conventional pulse width settings may lead to reduction of side effects and therefore be a valuable therapeutic option for deep brain stimulation (DBS) in patients with essential tremor (ET).

5. Switzerland pubmed.ncbi.nlm.nih.gov

Endurance of Short Pulse Width Thalamic Stimulation Efficacy in Intention Tremor. [2021] The benefit of short pulse width stimulation in patients suffering from essential tremor (ET) refractory to thalamic deep brain stimulation remains controversial. Here, we add to the minimal body of evidence available by reporting the effect of this type of stimulation in 3 patients with a persistent and severe intention tremor component despite iterative DBS setting adjustments. While a reduction in pulse width to 30 μs initially showed promise in these patients by improving tremor control and mitigating cerebellar side effects arguably by widening the therapeutic window, these benefits seemed to dissipate during early follow-up. Our experience supports the need for measuring longer-term outcomes when reporting the usefulness of this mode of stimulation in ET.

6. United States pubmed.ncbi.nlm.nih.gov

Early Experience With New Generation Deep Brain Stimulation Leads in Parkinson's Disease and Essential Tremor Patients. [2022] Newer generation deep brain stimulation (DBS) systems have recently become available in the United States. Data on real-life experience are limited. We present our initial experience incorporating newer generation DBS with Parkinson's disease (PD) and essential tremor (ET) patients. Newer systems allow for smart energy delivery and more intuitive programming and hardware modifications including constant current and directional segmented contacts.

7. England pubmed.ncbi.nlm.nih.gov

Square biphasic pulse deep brain stimulation for essential tremor: The BiP tremor study. [2019] Conventional deep brain stimulation (DBS) utilizes regular, high frequency pulses to treat medication-refractory symptoms in essential tremor (ET). Modifications of DBS pulse shape to achieve improved effectiveness is a promising approach.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Different effect of chronic electrical stimulation of the region of the superior cerebellar peduncle and the nucleus ventralis intermedius of the thalamus in the treatment of movement disorders. [2018] The stereotactic target for essential tremor is usually restricted to the nucleus ventralis intermedius of the thalamus, where total immediate suppression of tremor is obtained by continuous chronic electrical stimulation. According to authors' experience in cerebral palsy, chronic stimulation of the region of the superior cerebellar peduncle can diminish spasticity and dyskinesias. The effect of this stimulation is gradual and persists, so stimulation is applied 3-8 times daily for 15-20 min, and is accompanied by a feeling of pleasure. After interruption of chronic stimulation, the effects last for days or weeks. It is suggested that the changes in synaptic connections--reactive synaptogenesis--can also contribute.