Deep Brain Stimulation for Movement Disorders

Overseen By Nicole Bentley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate the brain activity associated with motor and non-motor symptoms of movement disorders, including Parkinson's disease (PD) and essential tremor. These movement disorders commonly have significant non-motor features, such as depression, cognitive and memory impairment, decreased attention, speech and language disturbances, and slower processing speeds. The investigators are interested in the brain activity associated with these motor and non-motor symptoms, and propose to investigate changes in brain activity while the investigators perform recordings of the surface and deep structures of the brain, in addition to the typical recordings the investigators perform, during routine deep brain stimulation (DBS) surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Deep Brain Stimulation for movement disorders?

Deep Brain Stimulation (DBS) is shown to be highly effective for treating movement disorders like essential tremor and dystonia, with studies indicating a 50% reduction in tremor severity and up to 80% improvement in motor symptoms for dystonia over several years. It is also a well-established treatment for advanced Parkinson's disease, significantly improving motor symptoms and quality of life. ^{1 2 3 4 5}

Is Deep Brain Stimulation generally safe for humans?

Deep Brain Stimulation (DBS) is generally well-tolerated, but it can have complications such as infections (2-16.2%), bleeding in the brain (1-6.3%), and seizures (1-3%). Some patients may need additional surgery to fix or remove the device if problems occur. ^{6 7 8 9 10}

How is deep brain stimulation different from other treatments for movement disorders?

Deep brain stimulation (DBS) is unique because it uses electrical impulses to modulate specific brain regions in a reversible and adjustable way, unlike other treatments that may involve permanent changes or medications. It has become a well-established option for advanced movement disorders like Parkinson's disease, offering an alternative to more invasive surgical procedures. ^{2 5 11 12 13}

Research Team

Nicole Bentley, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 with Parkinson's disease or Essential Tremor who are eligible for Deep Brain Stimulation (DBS) surgery. Candidates should be willing to participate in the study activities and have tried standard medical treatments without enough improvement.

Inclusion Criteria

A team of doctors agrees I am a candidate for DBS surgery.

I have been diagnosed with Parkinson's disease or Essential Tremor.

Willingness to participate in the paradigms described in the protocol

Exclusion Criteria

I am unable to understand and give informed consent.

Deep Brain Stimulation surgery is not recommended for my condition.

I cannot have surgery because of other health issues or because I am pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo deep brain stimulation (DBS) surgery and perform tasks to assess motor and non-motor symptoms

6 months

Multiple visits for pre- and post-operative assessments

Follow-up

Participants are monitored for changes in motor and cognitive functions post-treatment

3 months

Treatment Details

Interventions

• Deep Brain Stimulation
• Response Inhibition

Trial Overview The study investigates brain activity related to motor and non-motor symptoms of movement disorders during routine DBS surgery. It aims to understand changes in brain function associated with symptoms like depression, cognitive issues, and speech problems.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Parkinson's Disease Patients receiving DBS electrodes

Group II: Control Active Control 1 Intervention

Control subjects will be non-Parkinson's Disease patients with essential tremor

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Deep brain stimulation (DBS) is highly effective for treating advanced movement disorders, with essential tremor patients experiencing an average tremor reduction of about 50% over 1 to 5 years.

In patients with dystonia, DBS can lead to a significant decrease in motor severity scores by 50% to 80% over 2 to 3 years, with serious adverse events being rare, highlighting its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical considerations for tremor and dystonia. Cooper, S., Bowes, M.[2012]

Deep brain stimulation (DBS) is an effective treatment for movement disorders like Parkinson's disease and epilepsy, with ongoing advancements in both open-loop and closed-loop systems.

Recent research is increasingly focusing on closed-loop DBS systems, which may offer improved outcomes by adapting stimulation based on real-time feedback from the patient's brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directions of Deep Brain Stimulation for Epilepsy and Parkinson's Disease. Wu, YC., Liao, YS., Yeh, WH., et al.[2022]

In a study of 110 patients with deep brain stimulation (DBS) for movement disorders, 6.3% experienced a loss of clinical efficacy, often linked to increased electrode impedance (>4000 Ω).

Most patients with loss of efficacy required reoperation for electrode replacement, highlighting the need for a protocol to identify hardware issues early in patients receiving DBS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hardware complications in deep brain stimulation: electrode impedance and loss of clinical benefit. Guridi, J., Rodriguez-Oroz, MC., Alegre, M., et al.[2012]

Deep brain stimulation (DBS) is a highly effective and safe surgical treatment for advanced Parkinson's disease, essential tremor, and dystonia, significantly improving motor symptoms and quality of life in carefully selected patients.

DBS works by modulating cortical activity and reducing the need for medication, making it a reversible option that promotes better movement efficiency and understanding of the underlying neurocircuitry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement disorders and neuromodulation. Shipton, EA.[2022]

Deep brain stimulation (DBS) has proven to be a safe and effective treatment for movement disorders, particularly essential tremor and advanced Parkinson's disease, significantly improving patient outcomes.

Vim DBS has largely replaced thalamotomy for essential tremor, while STN and GPi DBS enhance 'on' time without dyskinesias in Parkinson's patients, indicating a shift towards more effective surgical options in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in neurostimulation for movement disorders. Gross, RE., Lozano, AM.[2019]

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

Deep brain stimulation (DBS) is effective for managing parkinsonian symptoms, but in rare cases, it can lead to severe mood disruptions, as demonstrated by a 58-year-old woman who developed rapid-onset depression during a routine battery replacement procedure after 5 years of DBS treatment.

Electroconvulsive therapy (ECT) proved to be an effective treatment for the patient's severe depression, highlighting its potential as a therapeutic option for patients experiencing intractable mood disorders related to DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. Cunningham, MG., Yadollahikhales, G., Vitaliano, G., et al.[2018]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

Deep Brain Stimulation (DBS) for Parkinson's disease can lead to rare complications, such as an intracranial abscess, as demonstrated in a case involving a 59-year-old male who developed significant inflammation and required multiple surgeries after the procedure.

Despite the complications, the patient's Parkinson's symptoms improved after the abscess was surgically drained, suggesting that the abscess may have inadvertently provided some therapeutic benefit similar to a subthalomotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracerebral abscess: a rare complication of Deep Brain Stimulation. Brandão, E., Rosas, MJ., Abreu, P., et al.[2013]

Deep brain stimulation (DBS) is a significant advancement in treating advanced movement disorders like Parkinson's disease and dystonias, offering a reversible and adjustable alternative to traditional lesioning procedures.

DBS targets specific brain regions, such as the subthalamic nucleus and globus pallidus internus, enhancing therapeutic efficacy while minimizing surgical complications, and is now also being explored for neuropsychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in the treatment of movement disorders]. Goto, S.[2008]

Radiofrequency lesions performed through deep brain stimulation (DBS) electrodes in two patients with movement disorders resulted in significant clinical improvements, with reductions in their Fahn-Tolosa-Marin Scale and Unified Parkinson's Disease Rating Scale scores over 20 and 8 months, respectively.

The procedure was safe, with no adverse effects reported, and allowed for better management of symptoms with lower current and medication requirements after treatment, suggesting it could be a valuable alternative in treating movement disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Lesions through Deep Brain Stimulation Electrodes in Movement Disorders: Case Report and Review of the Literature. Pérez-Suárez, J., Torres Díaz, CV., López Manzanares, L., et al.[2018]

Deep brain stimulation (DBS) is an established and evidence-based treatment for various movement disorders, but its effectiveness largely depends on the correct and timely indication for therapy.

The article emphasizes the importance of standardized procedures and published data in guiding the decision-making process for DBS, ensuring that it is applied appropriately in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in movement disorders: evidence and therapy standards]. Parpaley, Y., Skodda, S.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Surgical considerations for tremor and dystonia. [2012]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Directions of Deep Brain Stimulation for Epilepsy and Parkinson's Disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Hardware complications in deep brain stimulation: electrode impedance and loss of clinical benefit. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Movement disorders and neuromodulation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Advances in neurostimulation for movement disorders. [2019]

6. Austria pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]

7. Austria pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]

10. Spain pubmed.ncbi.nlm.nih.gov

Intracerebral abscess: a rare complication of Deep Brain Stimulation. [2013]

11. Japan pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in the treatment of movement disorders]. [2008]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Radiofrequency Lesions through Deep Brain Stimulation Electrodes in Movement Disorders: Case Report and Review of the Literature. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in movement disorders: evidence and therapy standards]. [2018]