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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores brain function in individuals with movement disorders such as Parkinson's disease and essential tremor. It examines both movement issues and other symptoms, including memory problems, depression, and slow thinking. The trial uses deep brain stimulation, a technique that sends electrical signals to parts of the brain, during surgery to observe changes in brain activity. Suitable participants have Parkinson's disease or essential tremor and are already scheduled for deep brain stimulation surgery. As an unphased trial, this study provides a unique opportunity to enhance understanding of brain function and potentially improve treatment for movement disorders.

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 prior data suggests that deep brain stimulation is safe for movement disorders?

Research has shown that deep brain stimulation (DBS) is generally well-tolerated by individuals with movement disorders like Parkinson's disease. Studies have found that DBS can enhance movement and has fewer side effects compared to some other treatments. Specifically, participants in past studies who underwent DBS demonstrated improved movement and could reduce their Parkinson's medications.

One study found that these improvements could last up to five years, indicating that DBS benefits both in the short term and over time. While any medical procedure carries risks, evidence suggests that DBS is a safe option for many individuals. However, discussing potential risks and benefits with a healthcare provider is crucial before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about deep brain stimulation (DBS) for movement disorders like Parkinson's Disease because it offers a unique approach compared to standard treatments such as medication and physical therapy. Unlike these traditional options, DBS involves implanting electrodes in specific brain areas to modulate abnormal brain activity directly. This method can be particularly beneficial for patients who do not respond well to medications or experience severe side effects. Additionally, DBS has the potential to provide more consistent relief from symptoms like tremors and rigidity, significantly improving patients' quality of life.

What evidence suggests that Deep Brain Stimulation is effective for movement disorders?

Research has shown that deep brain stimulation (DBS), which participants in this trial may receive, can greatly help people with Parkinson's disease. Studies have found that DBS significantly reduces movement issues like tremors and stiffness. It also allows patients to take less medication, which often has many side effects. In one study, more than 40 out of 51 participants experienced major improvements in their symptoms. DBS is now considered an effective treatment for enhancing the quality of life in people with Parkinson's. ^{1 2 3 6 7}

Who Is on the Research Team?

Nicole Bentley, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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) 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) 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]

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]

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]

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) 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]

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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30660117/

Long-term outcomes following deep brain stimulation for ... DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression in PD, ...

2. ufhealth.org ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

UF-led study shows deep brain stimulation benefits for ... “DBS used to be seen as a last resort, but we now know it provides the most sustained benefit when offered in the moderate stages of Parkinson's ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3002606/

Deep Brain Stimulation in Parkinson's Disease - PMC STN-DBS results in significant reduction of dyskinesias and dopaminergic medication, improvement of all cardinal motor symptoms with sustained long-term ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0967586825002954

Global improvement after deep brain stimulation in ... Among 51 PD patients, CGI rated 21 as “very much improved,” 21 “much improved,” and 9 “minimally improved,” primarily based on MDS-UPDRS III reduction.

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838886

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.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01839396

NCT01839396 | Deep Brain Stimulation (DBS) for the ... The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of ...

7. bmjmedicine.bmj.com bmjmedicine.bmj.com/content/3/1/e000705

Deep brain stimulation for Parkinson's disease: systematic ... Our results showed that participants receiving deep brain stimulation were likely to reduce their dose of antiparkinsonian drugs. This finding ...