80 Participants NeededMy employer runs this trial

Deep Brain Stimulation for Speech Sequencing in Parkinson's Disease

Recruiting at 1 trial location
FH
BG
Overseen ByBarbara G Holland, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston University Charles River Campus
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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.678910

Who Is on the Research Team?

FH

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

Corrected vision adequate to easily read text presented during speech motor task
Stable DBS program settings for at least one month
I am a native speaker of American English.
See 7 more

Exclusion Criteria

Pregnancy
For participants in the sub-syllabic sequence learning study (Study C.2.1), experience with the following languages: Hebrew, Polish, Lithuanian, Romanian, Georgian, Tepehua, Hungarian, and Pima
I do not have significant memory or thinking problems or active severe mental health symptoms.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo cognitive and motor assessments to establish baseline measures

1 day
1 visit (in-person)

Treatment

Participants complete speech tasks with DBS stimulation turned on and off to study effects on speech sequencing

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any changes in speech production and cognitive function post-treatment

2-4 weeks

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

Group I: Ventral intermediate thalamus with subsyllabic learning armExperimental Treatment2 Interventions
Group II: Ventral intermediate thalamus with multisyllabic learning armExperimental Treatment2 Interventions
Group III: Subthalamic nucleus with subsyllabic learning armExperimental Treatment2 Interventions
Group IV: Subthalamic nucleus with multisyllabic learning armExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials
125
Recruited
14,100+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

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.