Trial Summary
What is the purpose of this trial?This trial studies how Deep Brain Stimulation (DBS) affects voice control in patients with dystonia and essential tremor. DBS sends electrical impulses to brain areas that manage movement, aiming to improve voice function in these patients. Deep Brain Stimulation (DBS) has been used to treat severe movement disorders, including Parkinson's disease, dystonia, and essential tremor.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is Deep Brain Stimulation a promising treatment for Spasmodic Dysphonia and Tremor?Yes, Deep Brain Stimulation (DBS) is a promising treatment for Spasmodic Dysphonia and Tremor. Studies show that DBS can significantly improve vocal function in patients with Spasmodic Dysphonia, especially when applied to specific areas of the brain. Patients have experienced noticeable improvements in their symptoms, suggesting DBS could be an effective option for managing these conditions.34678
What safety data exists for Deep Brain Stimulation (DBS)?Deep Brain Stimulation (DBS) has been studied primarily for Parkinson's disease, essential tremor, and dystonia. Common complications include infections (16.2%), lead migrations (8.6%), circuit-related impedance (6.5%), cerebral bleeds (6.3%), device failure (6.3%), and device-related trauma (4.5%). Over 40% of adverse events required surgical intervention. Up to 10% of patients may experience neurobehavioral events. DBS is considered safer than lesion techniques like thalamotomy and pallidotomy, but it can still cause life-threatening complications requiring immediate attention.1591011
What data supports the idea that Deep Brain Stimulation for Spasmodic Dysphonia and Tremor is an effective treatment?The available research shows that Deep Brain Stimulation (DBS) can be effective for treating spasmodic dysphonia and tremor. In one study, two patients with both conditions experienced improvement in their symptoms after undergoing DBS. The study found that both patients improved most with stimulation on both sides of the brain, but there was also a strong benefit from stimulating just one side. Another study reviewed literature on DBS for voice disorders and highlighted its potential benefits, although it noted that many doctors are not familiar with the technique. Additionally, a systematic review and meta-analysis found that DBS can improve voice tremor severity and voice-related quality of life. These findings suggest that DBS is a promising treatment for these conditions.2371213
Eligibility Criteria
This trial is for adults aged 18-80 with voice disorders due to dystonia or essential tremor, who are candidates for deep brain stimulation (DBS) surgery. Participants must be able to follow instructions, complete training, and give informed consent. They should not have obstructive venous anatomy, significant hearing loss, or inability to perform required tasks.Inclusion Criteria
I am between 18 and 80 years old.
I am approved for DBS surgery for my essential tremor or dystonia by a specialist team.
Exclusion Criteria
I have significant hearing loss.
Treatment Details
The study aims to understand how often voice disorders occur in patients with dystonia and essential tremor treated with DBS. It will explore the changes in brain imaging and activity related to voice dysfunction before and after the treatment.
1Treatment groups
Experimental Treatment
Group I: Electrophysiological signal data collectionExperimental Treatment1 Intervention
Patients diagnosed with dystonia or tremor who are recommended for DBS surgery. Electrophysiological data will be collected at the time of DBS surgery.
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:
University of California San FranciscoSan Francisco, CA
Massachusetts General HospitalBoston, MA
University of UtahSalt Lake City, UT
Massachusetts General Hospital, University of California San Francisco, University of UtahBoston, MA
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Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
UMASS Memorial Medical CenterCollaborator
University of IowaCollaborator
University of UtahCollaborator
Massachusetts General HospitalCollaborator
University of California, San FranciscoCollaborator
References
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.
Coprevalence of tremor with spasmodic dysphonia: a case-control study. [2021]The aim of this study was to define the coprevalence of tremor with spasmodic dysphonia (SD).
Deep brain stimulation for treatment of voice disorders. [2012]Vocal tremor is a common, troublesome disorder that is difficult to treat. Efficacy of deep brain stimulation (DBS) was reported more than a decade ago. Most laryngologists are not familiar with the technique or its potential. This review was undertaken to assemble relevant literature written over the past decade and assess the clinical implications of that literature.
Treatment of spasmodic dysphonia with a neuromodulating electrical implant. [2014]To investigate the feasibility of an implantable electrical stimulation device to treat spasmodic dysphonia (SD) by neuromodulation of the muscle spindle gamma loop.
Critical reappraisal of DBS targeting for movement disorders. [2017]Deep brain stimulation (DBS) is used as a surgical treatment of movement disorders such as Parkinson's disease, dystonia and essential tremor. Fundamental understanding of DBS effects on the pathological neural circuitry remains insufficient. In 2002 DBS of the subthalamic nucleus (STN) and the globus pallidus internus (GPi) was approved for use in patients with PD. Next year, DBS of Gpi and STN for dystonia received a Humanitarian Device exemption from the FDA. The commonly targets for DBS are subthalamic nucleus (STN) or globus pallidus internus (GPi) for Parkinson's disease, Gpi for dystonia and ventro-intermediate (VIM) nucleus of the thalamus for essential tremor. However, VIM DBS cannot sufficiently improve akinesia and rigidity. Pedunculopontine nucleus (PPN) is currently investigated as potential target to improve gait and posture. It is determined that DBS sometimes influences not only motor functions but also the cognitive and affective functions of patients. In this article we review the present state of DBS for movement disorders, appropriate indications, practical effects and stimulation-induced adverse events established in previous studies. We discuss target selection and the effect of DBS on motor and non-motor symptoms of Parkinson's disease, dystonia and essential tremor.
The effect of unilateral thalamic deep brain stimulation on the vocal dysfunction in a patient with spasmodic dysphonia: interrogating cerebellar and pallidal neural circuits. [2019]Spasmodic dysphonia (SD) is a neurological disorder of the voice where a patient's ability to speak is compromised due to involuntary contractions of the intrinsic laryngeal muscles. Since the 1980s, SD has been treated with botulinum toxin A (BTX) injections into the throat. This therapy is limited by the delayed-onset of benefits, wearing-off effects, and repeated injections required every 3 months. In a patient with essential tremor (ET) and coincident SD, the authors set out to quantify the effects of thalamic deep brain stimulation (DBS) on vocal function while investigating the underlying motor thalamic circuitry. A 79-year-old right-handed woman with ET and coincident adductor SD was referred to our neurosurgical team. While primarily treating her limb tremor, the authors studied the effects of unilateral, thalamic DBS on vocal function using the Unified Spasmodic Dysphonia Rating Scale (USDRS) and voice-related quality of life (VRQOL). Since dystonia is increasingly being considered a multinodal network disorder, an anterior trajectory into the left thalamus was deliberately chosen such that the proximal contacts of the electrode were in the ventral oralis anterior (Voa) nucleus (pallidal outflow) and the distal contacts were in the ventral intermediate (Vim) nucleus (cerebellar outflow). In addition to assessing on/off unilateral thalamic Vim stimulation on voice, the authors experimentally assessed low-voltage unilateral Vim, Voa, or multitarget stimulation in a prospective, randomized, doubled-blinded manner. The evaluators were experienced at rating SD and were familiar with the vocal tremor of ET. A Wilcoxon signed-rank test was used to study the pre- and posttreatment effect of DBS on voice. Unilateral left thalamic Vim stimulation (DBS on) significantly improved SD vocal dysfunction compared with no stimulation (DBS off), as measured by the USDRS (p
Deep Brain Stimulation for Spasmodic Dysphonia: A Blinded Comparison of Unilateral and Bilateral Stimulation in Two Patients. [2021]Deep brain stimulation (DBS) is a promising new therapy for patients with spasmodic dysphonia (SD). The preliminary results from our randomized controlled trial showed good clinical effects with unilateral left thalamic stimulation in 6 right- handed patients. This suggests that the pathological process underpinning SD may have a "hemisphere dominant" pathway. We describe 2 patients with concurrent essential tremor and SD who had previously undergone bilateral thalamic DBS for their limb tremor. Both patients experienced an unanticipated improvement of their SD symptoms. One patient was right-handed, and the other was mixed left-handed. To investigate the amount of SD improvement following DBS therapy in each hemisphere, 4 different settings were tested: both sides on, left side on, right side on, and both sides off. Both patients most improved following bilateral stimulation. There was, however, a powerful unilateral benefit in both patients with only a small additional benefit from bilateral stimulation. The right-handed patient improved most with left-hemisphere stimulation whereas the mixed left-handed patient improved most with right hemisphere stimulation. There was some discrepancy between the two tests applied in the second patient reflecting the known difficulties to evaluate vocal symptom improvement in SD. We discuss the possible correlation of handedness and speech hemisphere dominance as well as the need for more reliable tests to measure SD severity. Ultimately, we recommend a bilateral approach for future studies, using a patient perception test as the primary outcome and functional imaging to further investigate the correlation of handedness and the amount of hemisphere dominance in SD.
Adductor Spasmodic Dysphonia Improves with Bilateral Thalamic Deep Brain Stimulation: Report of 3 Cases Done Asleep and Review of Literature. [2021]To date, there are only six published reports of adductor spasmodic dysphonia (SD) responding to awake thalamic deep brain stimulation (DBS).
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.
Non-motor Adverse Effects Avoided by Directional Stimulation in Parkinson's Disease: A Case Report. [2022]Deep brain stimulation (DBS) is widely used for treatment of advanced, medication-refractory Parkinson's disease (PD). However, a significant proportion of patients may suffer adverse effects; up to 10% will present one or more transient or permanent neurobehavioral events.
Development of Unilateral Peri-Lead Edema Into Large Cystic Cavitation After Deep Brain Stimulation: A Case Report. [2022]Deep brain stimulation (DBS) has been approved to treat a variety of movement disorders, including Parkinson's disease (PD), essential tremor, and dystonia. Following the DBS surgery, some perioperative and even delayed complications due to intracranial and hardware-related events could occur, which may be life-threatening and require immediate remedial measures.
Voice Improvement After Essential Tremor Treatment via Focused Ultrasound and Deep Brain Stimulation. [2023]The primary objective of this study was to determine whether two neurosurgical procedures, deep brain stimulation (DBS) and focused ultrasound (FUS), to treat essential tremor (ET) of the upper limb also reduce vocal tremor (VT) in patients with comorbid dysphonia.
Voice-Related Outcomes in Deep Brain Stimulation in Patients with Vocal Tremor: A Systematic Review and Meta-Analysis. [2023]The effectiveness of deep brain stimulation (DBS) in treating vocal tremors is currently a subject of debate. To assess the efficacy of DBS therapy in adults with vocal tremors (VT), we analyzed its impact on voice tremor severity, voice-related quality of life, fundamental frequency, voice intensity, and emotional state.