DBS System for Essential Tremor
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Must be taking: Propranolol, Primidone
Must not be taking: Anticoagulants
Disqualifiers: Parkinson's, Substance abuse, Severe comorbidities, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a feasibility study based on physician-initiated Investigational Device Exemption (IDE) including intraoperative experiments and chronic testing of implanted dual thalamic DBS lead systems. This study will inform protocols for optimal use of implanted next-gen DBS systems for primarily tremor control in refractory essential tremor.If the approach appears to be successful, the pilot data generated will be used to base a future pivotal trial for FDA approval for enhanced tremor control and adaptive DBS (aDBS) functionality of DBS systems.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that your tremor should be refractory (not responding) to at least two medications, including propranolol or primidone, before participating.
What data supports the effectiveness of this treatment for essential tremor?
Research shows that deep brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus is effective in reducing essential tremors, especially in cases where tremors are severe or have recurred after other treatments. Studies indicate that this treatment can provide significant and sustained tremor control, as seen in patients who have undergone thalamotomy or have tremor-dominant Parkinson's disease.
12345Is deep brain stimulation (DBS) for essential tremor safe?
Deep brain stimulation (DBS) for essential tremor is generally considered safe, but there are some risks. Common issues include device-related complications that may require additional surgeries, and mild side effects that can be managed by adjusting the device settings. Serious complications like bleeding in the brain or seizures are rare.
12367How is the DBS System for Essential Tremor treatment different from other treatments for this condition?
The DBS System for Essential Tremor is unique because it involves deep brain stimulation (DBS) targeting both the ventral intermediate nucleus (VIM) and ventral oralis (VO) of the thalamus, which may provide more comprehensive tremor control compared to traditional DBS that targets only the VIM. This approach can be particularly beneficial for patients with tremors that are not adequately managed by medication or other surgical options.
35689Eligibility Criteria
This trial is for adults over 21 with severe essential tremor that hasn't improved after trying at least two medications and ongoing traditional VIM DBS therapy. Participants must have a specific level of disability due to the tremor, be able to follow up throughout the study, and not have other central nervous system diseases or significant medical conditions.Inclusion Criteria
My tremor hasn't improved after trying two medications, including propranolol or primidone.
Patient is available for appropriate follow-up times for the length of the study
Patient gives an informed consent
+5 more
Exclusion Criteria
I might have Parkinson's disease or show symptoms like slow movement, stiffness, or balance problems.
I have a severe health condition that could affect my surgery tolerance.
You have a serious untreated or unstable mood disorder, like depression.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intraoperative Experiments
Intraoperative experiments to test the dual thalamic DBS lead systems
1 day
1 visit (in-person)
Chronic Testing
Chronic testing of implanted dual thalamic DBS lead systems for tremor control
24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests new dual lead thalamic DBS systems for controlling severe essential tremors in patients where current treatments aren't enough. It's an early-stage trial to see if this approach works well enough to plan larger trials aimed at FDA approval for these advanced DBS systems.
2Treatment groups
Active Control
Group I: Refractory ParticipantsActive Control2 Interventions
Patients with recurrent, debilitating intention tremor despite ongoing, optimized VIM DBS therapy
Group II: Treatment NaiveActive Control3 Interventions
Participants receiving Long-term stimulation of the thalamus via dual leads for Essential Tremor
ipsilateral thalamic (VIM+VO) DBS is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Medtronic DBS Therapy for Tremor for:
- Essential tremor
- Parkinsonian tremor
🇪🇺 Approved in European Union as Medtronic DBS Therapy for Tremor for:
- Essential tremor
- Parkinsonian tremor
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
MedtronicIndustry Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
[Surgical Technique of Ventral Intermediate Thalamic Deep Brain Stimulation]. [2021]Deep brain stimulation(DBS)of ventral intermediate(Vim)thalamic nucleus is an established procedure for tremor disorders, however, there are technical variations among specialists. The most common indications of Vim DBS are essential tremor(ET)and tremor dominant Parkinson's disease(PD), and less commonly other tremor disorders including Holmes tremor are treated with the same procedure. The variations of the surgical technique exist in the preoperative imagings and planning of the DBS electrode trajectory. In this review, we explain about the basic concept of Vim DBS and our surgical method.
Combination targeting of subthalamic nucleus and ventral intermediate thalamic nucleus with a single trajectory in deep brain stimulation for tremor-dominant Parkinson's disease. [2021]Deep brain stimulation (DBS) has traditionally been used to target the subthalamic nucleus (STN) or globus pallidus internus (GPi) to treat Parkinson's disease (PD) and the ventral intermediate thalamic nucleus (VIM) to treat essential tremor (ET). Recent case reports have described targeting both the STN and VIM with a single trajectory and electrode to treat patients with tremor-dominant PD, yet outcome data for this procedure remains sparse. Our objective is to determine the safety and efficacy of combination STN-VIM DBS. We conducted a single-center retrospective case series of all patients who underwent combined STN-VIM DBS. Demographic, perioperative, and outcome data, including Unified Parkinson Disease Rating Scale-III (UPDRS) and tremor scores (OFF-medication), and levodopa equivalent daily dose (LEDD), were collected and analyzed. Nineteen patients underwent this procedure. Patients were 89% male and 11% female, with a mean age of 63.6 years. Mean preoperative UPDRS was 24.1, and LEDD was 811.8. At a mean follow-up of 33.8 months, UPDRS and LEDD decreased by an average of 9.2 (38.2%) and 326.3 (40.2%), respectively. Tremor scores decreased by 4.9 (59.0%), and 58% were able to decrease total medication burden. One patient developed transient left-sided weakness, yielding a complication rate of 5.3%. Combined targeting of STN and VIM thalamus via a single frontal trajectory for tremor-dominant Parkinson's Disease results in similar UPDRS outcomes to STN DBS and improved control of tremor symptoms. Larger multicenter studies are necessary to validate this as the optimal DBS target for tremor-dominant PD.
Ipsilateral thalamic stimulation after thalamotomy for essential tremor. A case report. [2017]We report a patient with severe essential tremor who was treated with thalamic stimulation ipsilateral to a prior thalamotomy. Thalamotomy performed 30 years prior to stimulator implantation provided tremor reduction for one year before the tremor recurred. An electrode lead was implanted in the thalmaic nucleus ventralis intermedius (Vim) with nearly complete control of his tremor with sustained benefit over an 18-month follow-up period. Vim thalamic stimulation is an effective treatment option for recurrent tremor in patients who have undergone ipsilateral thalamotomy.
Lateralized effects of unilateral thalamotomy and thalamic stimulation in patients with essential tremor. [2021]Stereotactic thalamotomy has been an effective surgical procedure in the treatment of medically refractory essential tremor (ET), however, little is known about the bilateral effects of unilateral ventralis intermedius (Vim) thalamotomy and Vim deep brain stimulation (DBS). We studied the lateralized effects of unilateral Vim thalamotomy and Vim DBS in ET patients.
Staged Deep Brain Stimulation of Ventral Intermediate Nucleus of the Thalamus for Suppression of Essential Tremors. [2020]Deep brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus is a powerful surgical option in the treatment of essential tremors (ETs). However, its therapeutic efficacy depends on the tremor distribution. DBS is highly efficient in the relief of distal appendicular tremor but not other types of tremor. We report a case of staged DBS of ventral intermediate nucleus (VIM) of thalamus for the suppression of ETs.
[Deep brain stimulation for essential tremor. Consensus recommendations of the German Deep Brain Stimulation Association]. [2021]In Germany, deep brain stimulation (DBS) of the thalamic ventralis intermedius nucleus (VIM) is licensed for treatment of essential tremor in cases unresponsive to pharmacotherapy. Especially a bothersome hand tremor interfering with activities of daily living will improve, whereas head, tongue or vocal tremor shows less response. DBS was proven to be superior to lesional thalamotomy with better functional outcome and less adverse effects. The consensus statement presented here reflects the current recommendations of the German Deep Brain Stimulation Study Group for inclusion and exclusion criteria as well as for peri-, intra- and postoperative neurological management.
Long-term safety and efficacy of unilateral deep brain stimulation of the thalamus in essential tremor. [2022]Our objective was to investigate the long-term safety and efficacy of unilateral deep brain stimulation (DBS) of the VIM nucleus of the thalamus in essential tremor. Forty-nine patients were evaluated for DBS between December 1993 and March 1998. Tremor was assessed by a clinical rating scale at 3 and 12 months and then yearly. Three patients were not implanted, seven were explanted prior to 24 months, 11 were lost to long-term follow-up, and three died from unrelated causes. Twenty-five patients were evaluated with follow-up greater than or equal to 2 years. The last postsurgical follow-up occurred on average 40.2 +/- 14.7 months after surgery. Tremor scores were significantly improved with stimulation on at the long-term follow-up as compared to baseline. There was no change in tremor scores from baseline to long-term follow-up with stimulation off. There was no significant change in any stimulus parameters from 3 months to the long-term follow-up. Three patients had asymptomatic intracerebral hemorrhages and one patient had postoperative seizures. Stimulus-related adverse reactions were mild and easily controlled with changes in stimulus parameters. Device-related complications were common and required repeated surgical procedures. Unilateral DBS of the thalamus has long-term efficacy in some patients for treatment of essential tremor. However, this therapy is compromised by loss of efficacy in some patients and device complications which increase the risk of additional surgical procedures.
Long-Term Efficacy of Constant Current Deep Brain Stimulation in Essential Tremor. [2022]Ventralis intermedius deep brain stimulation is an established intervention for medication-refractory essential tremor. Newer constant current stimulation technology offers theoretical advantage over the traditional constant voltage systems in terms of delivering a more biologically stable therapy. There are no previous reports on the outcomes of constant current deep brain stimulation in the treatment of essential tremor. This study aimed to evaluate the long-term efficacy of ventralis intermedius constant current deep brain stimulation in patients diagnosed with essential tremor.
Simultaneous thalamic and posterior subthalamic electrode insertion with single deep brain stimulation electrode for essential tremor. [2022]The optimal target location of deep brain stimulation (DBS) is the subject of some controversy. We implanted electrodes that could stimulate both posterior subthalamic area (PSA) and ventralis intermedius nucleus of thalamus (Vim), and examined the benefits of bilateral DBS of Vim, PSA, and Vim + PSA in patients with essential tremor (ET).