Active biphasic pulse stimulation---VIN Biphasic for Familial Tremor

Phase-Based Estimates
1
Effectiveness
1
Safety
UF Health at the University of Florida, Gainesville, FL
Familial Tremor+3 More
Active biphasic pulse stimulation---VIN Biphasic - Device
Eligibility
18+
All Sexes
Eligible conditions
Familial Tremor

Study Summary

This study is evaluating whether a change in the way brain stimulation is delivered may help Essential Tremor patients.

See full description

Eligible Conditions

  • Familial Tremor
  • Essential Tremor
  • Dystonia
  • Parkinson Disease
  • Tremor

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Active biphasic pulse stimulation---VIN Biphasic will improve 2 primary outcomes and 3 secondary outcomes in patients with Familial Tremor. Measurement will happen over the course of up to 1 hour.

up to 1 hour
Baseline DBS settings versus active biphasic pulse DBS settings
up to 15 minutes
Gait impairment
The Fahn-Tolosa-Marin Tremor Rating Scale
Tremor motor physiology
up to 24 hours
Volume of tissue activated from stimulation with ET DBS

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Patients with Essential Tremor

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. Active Biphasic Pulse Stimulation---VIN Biphasic is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Patients with Essential TremorPatients 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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 hours for reporting.

Closest Location

UF Health at the University of Florida - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Existing unilateral or bilateral VIN DBS for ET, non-demented (MMSE>24), and must have a documented suboptimal tremor suppression on two successive visits (compared to the baseline post-operative improvement at 6 months following ET DBS surgery). For bilateral cases, the most affected tremor side will be studied.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes familial tremor?

Add answer

Family history of tremor is not a significant risk factor. However, a family history may identify a subgroup of patients who can benefit from diagnostic tools, such as electrophysiologic studies or genetic testing.

Unverified Answer

How many people get familial tremor a year in the United States?

Add answer

The prevalence of FT is likely variable across the US population, and no systematic study has yet used an objective method to evaluate the prevalence of FT in US populations. One review of studies in Canada found no prevalence estimates for FT, and another of studies in Texas found estimates of 3.7% to 6.2%. The prevalence in the authors' institution is 4.4%. Given the widespread use of EMG by neurologists and the general interest in FT, further studies to define the prevalence of FT and evaluate other aspects of its genetic heterogeneity is warranted.

Unverified Answer

What are the signs of familial tremor?

Add answer

tremor in family members is a sign of inherited tremor, not a new symptom. In familial tremor, other symptoms of inherited tremor may also occur. The diagnosis of familial tremor should be based on the family history, rather than on physical examinations or neurologic examinations by family physicians.

Unverified Answer

What is familial tremor?

Add answer

Tremor can be characterized by bradykinesia with rapid alternating movement, typically from shoulder to finger. There is no known curative therapy unless the tremor can be controlled with medications or other treatments.\n

Unverified Answer

What are common treatments for familial tremor?

Add answer

The two most obvious and commonly used treatments for familial tremor are levodopa and dopamine agonists. Both treatments (Levodopa and Dopamine agonists) are commonly used as the initial treatment for kindreds of tremor who have had a family history of tremor and whose tremor has not been responsive to medication and/or surgery. However, levodopa and dopamine agonists do have advantages and disadvantages compared to surgery.

Unverified Answer

Can familial tremor be cured?

Add answer

The familial tremor phenotype could, in a limited number of patients, be cured by botulinum-A injection. This must be interpreted with caution, requiring the evaluation of alternative treatments in all patients.

Unverified Answer

Have there been other clinical trials involving active biphasic pulse stimulation---vin biphasic?

Add answer

The active biphasic pulse stimulation and vin biphasic stimulation have comparable effects of reducing active myoclonus, tremor amplitude, and muscle fatigue; in addition, they have similar adverse effects.

Unverified Answer

What is active biphasic pulse stimulation---vin biphasic?

Add answer

Vin biphasic pulse stimulation is effective in reducing postoperative overactive tendon jerks, improving sleep and reducing pain. The method is simple and portable and is safe in children.

Unverified Answer

How does active biphasic pulse stimulation---vin biphasic work?

Add answer

Data from a recent study of this study show that the activity of biphasic VS improves the function of the VB. Data from a recent study may be clinically important because the presence of increased activity of the VB can result in more efficient stimulation of the VIB, improving the efficacy of the biphase protocol.

Unverified Answer

What does active biphasic pulse stimulation---vin biphasic usually treat?

Add answer

Results from a recent clinical trial demonstrate that active vin biphasic pulse stimulation can be used to abort or abortise tremor if a previously unresponsive tremor is present; when treating previously unresponsive chronic (postpyramidal) dystonia tremor, vin biphasic pulse stimulation may be an important complementary tool.

Unverified Answer

Does active biphasic pulse stimulation---vin biphasic improve quality of life for those with familial tremor?

Add answer

Compared with vin monophasic stimulation, vin biphasic stimulation did not improve motor and non-motor functioning in adult patients with FT, but did seem to improve mood and QoL, potentially by activating peripheral vestibular systems.

Unverified Answer

Have there been any new discoveries for treating familial tremor?

Add answer

In the world of medicine, there are fewer and fewer medical procedures that have been studied and described; as well as fewer discoveries made based on them. However, we should not get discouraged; we should continue to look the way we've looked before: and try to find the simplest, best-tasting, and simplest-to-make [drinks] to treat FTM.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Familial Tremor by sharing your contact details with the study coordinator.