Deep Brain Stimulation for Speech Sequencing in Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how deep brain stimulation (DBS) affects speech learning and production in people with Parkinson's disease and essential tremor. Researchers are examining how two brain areas, the subthalamic nucleus (STN) and the ventral intermediate nucleus of the thalamus (VIM), assist in learning new speech sequences. Participants will perform speech tasks with their DBS devices turned on or off to observe the influence on their ability to learn and produce speech. Individuals with Parkinson’s or essential tremor who have DBS devices and stable treatment plans might be suitable candidates. The insights gained could lead to improved DBS settings that enhance both movement and speech for people with these conditions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could advance DBS therapy for speech and movement.
Do I need to stop my current medications for the trial?
The trial requires that your Parkinson's disease or essential tremor medication regimen be stable for at least one month before participating. This means you should not change your current medications during the trial.
What prior data suggests that these DBS devices are safe for speech sequencing in Parkinson's disease?
Research has shown that deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) is generally safe for treating Parkinson's disease. Studies have found it effective in improving movement problems with a low risk of serious side effects. For instance, one study reported significant improvements in movement over five years while maintaining safety.
Similarly, DBS targeting the ventral intermediate nucleus (VIM) of the thalamus is considered safe and effective, particularly for controlling tremors in conditions like essential tremor. Research indicates that VIM-DBS successfully reduces tremor symptoms without major side effects.
Both STN and VIM DBS treatments are well-tolerated by patients and have a strong safety record in clinical settings. These findings suggest that participants in the trial can expect a similar level of safety with these DBS procedures.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it's exploring how deep brain stimulation (DBS) might improve speech sequencing in individuals with Parkinson's disease. Unlike standard treatments, which often focus on dopamine replacement and managing symptoms with medication, this trial uses DBS to potentially enhance brain function directly. By targeting specific brain areas—the subthalamic nucleus and the ventral intermediate thalamus—while subjects engage in language learning tasks, researchers hope to uncover new insights into how DBS can be used to support speech production. This approach could lead to breakthroughs in improving speech and communication, offering new hope for people with Parkinson's.
What evidence suggests that this trial's treatments could be effective for speech sequencing in Parkinson's disease?
Research has shown that deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) can improve speech and voice quality in people with Parkinson's disease. In this trial, some participants will receive STN-DBS while engaging in learning tasks involving either non-English sound sequences or syllable sequences. Some studies suggest that STN-DBS can help restore certain speech patterns, although its effects on speech fluency can vary.
For those with essential tremor, DBS targeting the ventral intermediate nucleus (VIM) effectively reduces tremors but can sometimes impair speaking ability. In this trial, other participants will receive VIM-DBS while engaging in similar learning tasks. Overall, STN-DBS has shown positive results in controlling speech, while VIM-DBS effectively controls tremors but has mixed effects on speech.678910Who Is on the Research Team?
Frank H Guenther, Ph.D.
Principal Investigator
Boston University
Are You a Good Fit for This Trial?
This trial is for adults (18+) with Parkinson's disease or essential tremor who have a deep brain stimulator (DBS) in either the subthalamic nucleus or VIM thalamus. Participants must be native American English speakers, able to read text, have stable DBS and medication settings, normal hearing, and no major cognitive or speech impairments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo cognitive and motor assessments to establish baseline measures
Treatment
Participants complete speech tasks with DBS stimulation turned on and off to study effects on speech sequencing
Follow-up
Participants are monitored for any changes in speech production and cognitive function post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cessation and re-enabling of stimulation of the STN
- Cessation and re-enabling of stimulation of the VIM thalamic nucleus
- Multisyllabic sequence learning
- Phoneme sequence learning
Trial Overview
The study tests how turning DBS on and off in different brain areas affects learning and producing new speech sound sequences. Participants will do speech tasks while researchers record their brain activity using advanced DBS devices.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Arm 3: subjects with implanted VIM deep brain stimulators will undergo learning tasks involving non-English sound sequences while their stimulators are turned on and off
Arm 4: subjects with implanted VIM deep brain stimulators will undergo learning tasks involving syllable sequences while their stimulators are turned on and off
Arm 1: subjects with implanted STN deep brain stimulators will undergo learning tasks involving non-English sound sequences while their stimulators are turned on and off
Arm 2: subjects with implanted STN deep brain stimulators will undergo learning tasks involving syllable sequences while their stimulators are turned on and off
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston University Charles River Campus
Lead Sponsor
Massachusetts General Hospital
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Citations
Five-Year Outcomes from Deep Brain Stimulation of the ... - PMC
This cohort study evaluates 5-year outcomes and safety of subthalamic nucleus deep brain stimulation for the treatment of Parkinson disease.
Direct subthalamic nucleus stimulation influences speech ...
STN-DBS can considerably improve both speech and voice quality based on a carefully arranged stimulation regimen along central stimulation features.
Long-term effects of subthalamic nucleus deep brain ...
The objective of this study was to evaluate the long-term effects of bilateral STN-DBS on speech in a cohort of advanced PD patients treated with bilateral STN ...
The Effect of Deep Brain Stimulation of the Subthalamic ...
This systematic review focuses on the effect of bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) on language function in Parkinson's ...
Can sub-thalamic deep brain stimulation (STN-DBS) improve ...
This critical review examined the effects of subthalamic deep brain stimulation (STN –DBS) on speech in patients with Parkinson's disease. Study designs ...
The safety profile of subthalamic nucleus and globus pallidus ...
The study concluded that STN DBS remains an effective treatment for motor symptoms of Parkinson's Disease with a low risk of severe morbidity.
Five-Year Outcomes from Deep Brain Stimulation of the ...
This cohort study evaluates 5-year outcomes and safety of subthalamic nucleus deep brain stimulation for the treatment of Parkinson disease.
Early Subthalamic Nucleus Deep Brain Stimulation in ... - PMC
Subthalamic nucleus (STN) deep brain stimulation (DBS) is recognized as a safe and effective treatment in mid- and advanced-staged Parkinson's disease (PD) ...
Subthalamic nucleus deep brain stimulation alleviates ...
Our previous study found that STN-DBS could exert neuroprotective effects against 6-OHDA-induced cell injury in PD by inducing autophagy.
Sustained Benefits of Deep Brain Stimulation of the ...
This 5-year data demonstrates that STN-DBS provides significant and sustained improvements in motor function and activities of daily living.
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