Deep Brain Stimulation for Essential Tremor
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByAlbert J Fenoy, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwell Health
Disqualifiers: Neurological disorder, Dementia, Psychiatric illness, others
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the trial is for people whose tremor is not helped by medications or who have intolerable side effects, it's possible you may continue your current treatment.
What data supports the effectiveness of the treatment Deep Brain Stimulation for Essential Tremor?
Research shows that Deep Brain Stimulation (DBS) is effective in reducing tremors and improving daily life activities for people with essential tremor. Studies indicate significant improvements in tremor scores and disability ratings, with DBS being equally effective for essential tremor and Parkinson's disease.
12345Is deep brain stimulation (DBS) generally safe for humans?
Deep brain stimulation (DBS) is generally considered safe, with most adverse events being mild and manageable. Common complications include infections and lead migrations, and some cases may require additional surgery. However, it is one of the safest treatments for conditions like Parkinson's disease and essential tremor.
678910How is deep brain stimulation different from other treatments for essential tremor?
Deep brain stimulation (DBS) is unique because it involves implanting electrodes in specific brain areas to modulate abnormal signals, offering a reversible and adjustable treatment option for essential tremor, unlike traditional medications or surgical ablation procedures.
1241112Eligibility Criteria
This trial is for individuals with Essential Tremor that's not caused by another disease or injury, who haven't found relief through medications, or can't tolerate medication side effects. Their tremors must significantly affect their life quality and be confirmed by a specialist. People with severe psychiatric issues, cognitive impairments, metal in their body, recent substance abuse, pregnancy, prior brain surgery in the target area, significant neurological disorders other than ET or major medical conditions affecting the brain are excluded.Inclusion Criteria
My tremor doesn't improve with medications or the side effects are too severe.
I have been diagnosed with Essential Tremor by a specialist, not caused by another condition or injury.
My tremor severely affects my daily life.
+1 more
Exclusion Criteria
I have had surgery to target a specific area of my brain.
I cannot have surgery for deep brain stimulation.
I have a severe mental health condition with thoughts of harming myself.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Deep Brain Stimulation (DBS) is applied to the dentato-rubro-thalamic tract (DRTt) to study structural and functional connectivity changes
During DBS placement surgery
Follow-up
Participants are monitored for changes in tremor and ataxia after DBS
72 hours
Participant Groups
The study is examining how Deep Brain Stimulation (DBS) of the dentato-rubro-thalamic tract affects both the physical connections within this brain region and its activity patterns to improve tremors in Essential Tremor patients.
1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation(DBS)Experimental Treatment1 Intervention
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
🇪🇺 Approved in European Union as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
🇨🇦 Approved in Canada as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
North Shore University HospitalManhasset, NY
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
Northwell HealthLead Sponsor
The University of Texas Health Science Center, HoustonLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Long-term effects of deep brain stimulation for essential tremor with subjective and objective quantification via mailed-in questionnaires. [2015]Deep brain stimulation (DBS) is a standard treatment for patients with disabling essential tremor. The short-term efficacy rate is well established.
Current clinical application of deep-brain stimulation for essential tremor. [2022]Deep-brain stimulation (DBS) is an established treatment for medically refractory essential tremor (ET). This article reviews the current evidence supporting the efficacy and safety of DBS targets, including the ventral intermediate (VIM) nucleus and posterior subthalamic area (PSA) in treatment of ET.
Effects of thalamic deep brain stimulation based on tremor type and diagnosis. [2006]It has been suggested that deep brain stimulation (DBS) is less effective in alleviating proximal than distal postural arm tremor reduction is said to be less in essential tremor (ET) than in Parkinson's disease (PD). We analyzed blinded rater's tremor scores and subjects' disability ratings at 3-month follow-up to examine the effects of DBS based on tremor type (rest, kinetic, distal postural, proximal postural) and diagnosis (ET, PD). An independent examiner provided tremor scores using randomized videotaped footage of 19 ET and 10 PD subjects at baseline and at follow-up with DBS "on." Subjects provided self-ratings of disability at baseline and at follow-up. Comparisons of baseline and follow-up tremor scores and disability ratings were made using the Mann-Whitney U and Wilcoxon rank sum W test; correlation analyses were performed using Spearman rank order correlation test. There were significant and essentially equal improvements in tremor scores of test, kinetic, distal postural, and proximal postural tremor at follow-up. Only one subject had no improvement in tremor. Tremor improved significantly and to the same extent in ET and PD subjects in each position except "at rest," which was most improved in PD (p = 0.0003). ET and PD subjects did not differ in the extent of disability improvement. Improved disability correlated only with improved postural tremor scores; proximal postural and distal postural (r = 0.41, p = 0.03; r = 0.47, p = 0.01). DBS is effective in alleviating tremor and disability in both ET and PD. Resting, kinetic, distal postural, and proximal postural tremor can be reduced to an equal degree. However, DBS produces the greatest improvement in disability in association with improved postural tremor in both ET and PD.
Deep brain stimulation in essential tremor: targets, technology, and a comprehensive review of clinical outcomes. [2021]Introduction: Essential tremor (ET) is a common movement disorder with an estimated prevalence of 0.9% worldwide. Deep brain stimulation (DBS) is an established therapy for medication refractory and debilitating tremor. With the arrival of next generation technology, the implementation and delivery of DBS has been rapidly evolving. This review will highlight the current applications and constraints for DBS in ET.Areas covered: The mechanism of action, targets for neuromodulation, next generation guidance techniques, symptom-specific applications, and long-term efficacy will be reviewed.Expert opinion: The posterior subthalamic area and zona incerta are alternative targets to thalamic DBS in ET. However, they may be associated with additional stimulation-induced side effects. Novel stimulation paradigms and segmented electrodes provide innovative approaches to DBS programming and stimulation-induced side effects.
Long-term effect of deep brain stimulation for essential tremor on activities of daily living and health-related quality of life. [2022]To report long-term effects of thalamic deep brain stimulation (DBS) on activities of daily living (ADL) and health-related quality of life (HRQoL) in patients with essential tremor (ET).
Deep brain stimulation for essential tremor: a systematic review. [2022]Deep brain stimulation (DBS) is a neurosurgical treatment, which has proven useful in treating Parkinson's disease. This systematic review assessed the safety and effectiveness of DBS for another movement disorder, essential tremor. All studies concerning the use of DBS in patients with essential tremor were identified through searching of electronic databases and hand searching of reference lists. Studies were categorized as before/after DBS or DBS stimulation on/off to allow the effect of the stimulation to be analyzed separately to that of the surgery itself. A total of 430 patients who had received DBS for essential tremor were identified. Most of the reported adverse events were mild and could be treated through changing the stimulation settings. Generally, in all studies, there was a significant improvement in outcomes after DBS compared with baseline scores. In addition, DBS was significantly better in testing when the stimulation was turned on, compared with stimulation turned off or baseline. Based on Level IV evidence, DBS is possibly a safe and effective therapy for essential tremor.
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]Introduction Deep brain stimulation (DBS) is a modality of treatment for medication refractory Parkinson's disease (PD) in patients with debilitating motor symptoms. While potentially life-changing for individuals with Parkinson's disease, characterization of adverse events for these DBS devices have not yet been systematically organized. Therefore, the goal of this study was to characterize reported complications of DBS devices reported to the Food & Drug Administration over the last 10 years. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was utilized to retrieve entries reported under "Stimulator, Electrical, Implanted, For Parkinsonian Symptoms" between July 31, 2010 and August 1, 2020. After removing duplicate entries, each unique adverse event reported was sorted into complication categories based on the entries' provided narrative description. A final tabulation of complications was generated. Results The search query revealed 221 unique adverse events. The most common DBS devices were the Vercise Gevia, Vercise Cartesia and Vercise PC produced by Boston Scientific (Brian Walker, Boston Scientific, Marlborough, MA, USA). The most commonly reported complications were infection (16.2%) follow by lead migrations (8.6%). Other common causes of complications were circuit-related impedance (6.5%), cerebral bleeds (6.3%), device failure (6.3%) and device-related trauma (4.5%). Over a third (40%) of all devices reported with adverse events required returning to the operating room for explant or revision. Conclusion The most common complications of DBS systems are infections followed by lead migrations. Further research is needed to minimize infection rates associated with DBS systems and to reduce intrinsic device malfunctions for patients in the future.
Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]Deep brain stimulation (DBS) is a surgical technique used to alleviate symptoms in patients with advanced Parkinson's disease (PD). It is a reversible procedure and its effect is based on electrical modulation of the nervous system and has considerable advantages in morbidity-mortality when compared to lesion techniques such as thalamotomy and/or pallidotomy. The objective was to evaluate the adverse events during the surgical placement of leads in the subthalamic nucleus for the treatment of Parkinson's disease.
Which one is the superior target? A comparison and pooled analysis between posterior subthalamic area and ventral intermediate nucleus deep brain stimulation for essential tremor. [2022]The efficacy and safety of posterior subthalamic area (PSA) and ventral intermediate nucleus (VIM) deep brain stimulation (DBS) in the treatment of essential tremor (ET) have not been compared in large-scale studies. We conducted a secondary analysis to identify the superior target of ET-DBS treatment.
Deep brain stimulation for Parkinson's disease: the Vanderbilt University Medical Center experience, 1998-2004. [2007]Deep brain stimulation (DBS) has become increasingly popular to treat the symptoms of Parkinson's disease (PD) that are no longer adequately controlled by oral medications. This report summarizes safety and efficacy outcomes for 72 patients who underwent DBS surgery at Vanderbilt University Medical Center between September 1998 and December 2004. Efficacy was measured by reduction in anti-PD medications; patients saved an average of $2,292 per year after surgery. The most common adverse event was intracranial hemorrhage (12.5 percent), which led to permanent deficits in one patient (1.4 percent) and transient deficits in five patients (6.9 percent). The next most common event was DBS lead infection in seven patients (9.7 percent). Our experience provides further evidence that DBS is one of the safest and most effective treatments for PD patients suffering from motor complications.
Decoding voluntary movements and postural tremor based on thalamic LFPs as a basis for closed-loop stimulation for essential tremor. [2023]High frequency Deep brain stimulation (DBS) targeting motor thalamus is an effective therapy for essential tremor (ET). However, conventional continuous stimulation may deliver unnecessary current to the brain since tremor mainly affects voluntary movements and sustained postures in ET.
The treatment of movement disorders by deep brain stimulation. [2022]It has been understood, for some time, that modulation of deep brain nuclei within the basal ganglia and thalamus can have a therapeutic effect in patients with movement disorders. Because of its reversibility and adjustability, deep brain stimulation (DBS) has largely come to replace traditional ablation procedures. The clinical effects of DBS vary, depending both on the target being stimulated and on the parameters of stimulation. Both aspects are currently the subject of substantial research and discovery. The most common targets for DBS treatment include the subthalamic nucleus for the treatment of advanced Parkinson's disease, the ventral intermediate nucleus of the thalamus for the treatment of medically refractory essential tremor, and the globus pallidus interna for the treatment of both cervical and generalized dystonias and Parkinson's disease. We review the current indications, targets, outcomes, and general procedure of DBS for essential tremor, Parkinson's disease, and dystonia.