CLINICAL TRIAL

DBS Electrode Implantation using D1 Sterotactic System for Familial Tremor

Waitlist Available · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a new type of brain surgery can help treat individuals with neurological disorders.

See full description

About the trial for Familial Tremor

Eligible Conditions
Tourette Syndrome · Compulsive Personality Disorder · Obsessive-Compulsive Disorder · Parkinson Disease · Essential Tremor · Dystonia

Treatment Groups

This trial involves 2 different treatments. DBS Electrode Implantation Using D1 Sterotactic System 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
DBS Electrode Implantation using D1 Sterotactic System
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Must be adult subjects with medically intractable neurological disorder who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Within 1 month post-DBS surgery.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Within 1 month post-DBS surgery..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether DBS Electrode Implantation using D1 Sterotactic System will improve 4 primary outcomes in patients with Familial Tremor. Measurement will happen over the course of Within 1 month post-DBS surgery..

Operating room time
WITHIN 1 MONTH POST-DBS SURGERY.
Operating room time will be counted and compared to conventional procedure (using Leksell frame). The average operating room time will be compared between conventional procedure and D1 Stereotactic System procedure. Significantly lower operating room time will be accounted as success criteria
3D Euclidian distance error
WITHIN 1 MONTH POST-DBS SURGERY.
3D Euclidian distance error between the MR planned coordinate (XP, YP, ZP) and CT confirmed actual DBS coordinate (XA, YA, ZA) will be calculated. The 3D distance error comparable or lower to conventional system will be accounted as success criteria.
Trajectory accuracy
WITHIN 1 MONTH POST-DBS SURGERY.
A trajectory accuracy will be determined by comparing Collar Angle (CA) and Arc Angle (AA) between MR planned angles (CAP and AAP) and CT confirmed actual angles (CAA and AAA). The non-significant difference between MR planned and CT confirmed angles will be accounted as success criteria.
Comfort level questionnaire
WITHIN 1 MONTH POST-DBS SURGERY.
Comfort level questionnaire will be given to each subject after DBS surgery and removal of the device to assess their overall experience with device and surgery.

Who is running the study

Principal Investigator
K. J. M.
Kai J. Miller, Principle Investigator
Mayo Clinic

Patient Q & A Section

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

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

The American Cancer Society estimates 4,280 new diagnoses of essential tremor will be made in 2003. The rate and incidence of this disorder is increasing.

Anonymous Patient Answer

What is familial tremor?

We have reported a family of six with a genetic cause of focal cerebellar tremor, with a high prevalence of autosomal dominant inheritance. Familial tremor is an autosomal dominant disorder characterized by unsteady, jerky movements of the head and limbs, with an unsteady, jerky breathing. The most severe and profound of these symptoms present themselves when the infant is in the neonatal period, as in the family we described.

Anonymous Patient Answer

Can familial tremor be cured?

We believe that a correct diagnosis and appropriate management of tremors is extremely important at all ages. The aim of the present paper is to describe the best known cases of familial tremor to emphasize that tremors will never be "cured" by medical remedies and should be treated with behavioral remedies. We also believe that the management of familial tremor is best achieved through an interdisciplinary approach. Patients with familial tremor and their at-risk relatives should be educated to help identify symptoms and to support each other and seek out appropriate care to minimize stress. If symptomatic medication is started before the tremor reaches severe levels, the tremors can be managed effectively.

Anonymous Patient Answer

What causes familial tremor?

The cause of tremor in a large proportion of patients remains unknown. Genetic factors, environmental, immunological or metabolic factors may interact in some families. There is no single single causative factor.

Anonymous Patient Answer

What are common treatments for familial tremor?

In many cases, patients with tremor were dissatisfied with available treatment for their tremor. Physicians should reassure patients that the disease will improve with time, that various medical treatments could be effective, and that the tremor may get better over time if the disease is caused by a genetic abnormality.

Anonymous Patient Answer

What are the signs of familial tremor?

The most common presenting feature of familial tremor is the tremor. Other common autonomic features of familial tremor are dry mouth and hypopreflexia. Hypercapnic tremor may be an association of familial tremor/essential tremor and also features of cerebellar degeneration. Other aspects of family history have been included within the list of the signs of familial tremor. Many families are genetically linked to idiopathic tremor.

Anonymous Patient Answer

Have there been other clinical trials involving dbs electrode implantation using d1 sterotactic system?

The use of an intraoperative computed tomography was able to confirm the position of the device as well as the location of its exit from the bone surface. Data from a recent study revealed that the dbs electrode implantation procedure was not effective in all patients. The mechanism explaining its failure is not fully understood. However, further studies are needed to evaluate more patients in order to better understand this issue.

Anonymous Patient Answer

What is the primary cause of familial tremor?

The most common cause of familial tremor is a mutation on chromosome 15q in GNA1 or GNA3 genes. The location of tremor in the hands can often be deduced by finding one of these genes in the gene search, which will usually take only a minute. Tremor can also be secondary to another disease or disorder with multiple loci.

Anonymous Patient Answer

How does dbs electrode implantation using d1 sterotactic system work?

Dbs electrode implantation using d1 Sterotactic System does not seem to be associated with higher risk of complications when compared to bilateral standard system (bilateral stereotactic breast biopsy (BBB)) implantation.

Anonymous Patient Answer

Is dbs electrode implantation using d1 sterotactic system typically used in combination with any other treatments?

DBS electrode implantation using d1 stereotactic system for FET typically provides the best results without significant increase of additional treatment sessions. Stereotactic-guided technique in combination with other techniques can be used only in small group of epilepsy patients.

Anonymous Patient Answer

What are the common side effects of dbs electrode implantation using d1 sterotactic system?

DBS electrode placement in a stereotactic manner is an effective and safe minimally invasive surgical treatment for MFS. Immediate improvement of facial weakness occurs with minimal procedural complications.

Anonymous Patient Answer

Does dbs electrode implantation using d1 sterotactic system improve quality of life for those with familial tremor?

Dbs electrode implantation using the d1 stereotactic system improves quality of life and reduced tremor amplitude and intensity in patients with familial tremor. The improvements can be maintained for 2-4 years after implantation.

Anonymous Patient 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.