STN DBS for Parkinson's Disease

Recruiting at 1 trial location

Overseen By Kaeli Spight

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Neurologic, Psychiatric, Dementia, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

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 brain networks in people with Parkinson's disease. DBS helps with movement but can sometimes cause mood or cognitive issues. The trial uses a new imaging method, HD-DOT, to observe how DBS changes brain connections and improves treatment. People with Parkinson's who have undergone DBS surgery might be suitable if they experience changes in movement or thinking. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future DBS treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants must tolerate being off medication or off DBS states, which might imply some adjustments to your current medication regimen.

What prior data suggests that this method is safe for Parkinson's disease patients?

Research has shown that deep brain stimulation (DBS) targeting a specific brain area is generally safe for people with Parkinson's disease. Studies have found that side effects are rare and usually short-lived. These studies have not reported serious problems like death, muscle weakness, or seizures. Over time, DBS has helped with movement issues and improved quality of life.

Although the benefits might lessen as Parkinson's progresses, the treatment remains well-tolerated. DBS has been used for many years and has a strong record of safety and effectiveness in managing Parkinson's symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment options for Parkinson's Disease, which often involve medication like Levodopa or dopamine agonists, STN DBS (Subthalamic Nucleus Deep Brain Stimulation) offers a unique approach by directly targeting the brain. This treatment involves surgically implanting electrodes in the brain to modulate abnormal neural activity, providing more consistent symptom control. Researchers are excited about STN DBS because it can significantly reduce motor symptoms and medication reliance, potentially leading to a better quality of life for patients. Additionally, the ability to adjust stimulation parameters makes it a customizable treatment, tailored to the needs of each individual.

What evidence suggests that STN DBS is effective for Parkinson's disease?

Research has shown that deep brain stimulation (DBS) of the subthalamic nucleus effectively treats Parkinson's disease. It reduces common symptoms like tremors and stiffness, enhancing patients' mobility. In this trial, participants will join a post-surgical group and undergo scanning and testing with DBS turned ON and OFF. Studies have found that many patients experience significant improvements in movement. DBS is generally safe for most people, with benefits lasting several years. However, some individuals might experience changes in mood or thinking, which researchers continue to study. Overall, DBS is a reliable treatment option for improving the quality of life in people with Parkinson's. ^{1 5 6 7 8}

Who Is on the Research Team?

Tamara G Hershey, PhD

Principal Investigator

Washington University Medical School

Are You a Good Fit for This Trial?

This trial is for adults with Parkinson's Disease (PD) who are either planning to have, or have already had, deep brain stimulation surgery in the subthalamic nucleus. It includes those aged 50-75 and a control group without PD matched by age and sex. Exclusions include significant neurological/psychiatric conditions, MRI contraindications, severe visual loss, non-English speakers, and illiteracy.

Inclusion Criteria

I am between 50-75 years old, diagnosed with Parkinson's, and have had DBS surgery.

I am between 20 and 75 years old and do not have a definite diagnosis of Parkinson's disease.

I am between 50 and 75 years old, diagnosed with Parkinson's, and approved for deep brain stimulation surgery.

Exclusion Criteria

Pilot Group: Exclusions include any significant past or current neurologic or psychiatric diagnosis, conditions interfering with testing, and contraindications for MRI

Pre-Surgical DBS Group: Exclusions include contraindications for MRI pre-surgically, inability to tolerate off medication or off DBS states, and conditions interfering with testing

Control Group: Exclusions include any significant past or current neurologic or psychiatric diagnosis, conditions interfering with testing, and contraindications for MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Assessment

Pre-surgical assessments including MRI/fMRI imaging and cognitive tests

4-6 weeks

Multiple visits for imaging and assessments

Surgical and Post-Surgical Optimization

STN DBS surgery followed by clinical optimization of DBS settings

8-12 weeks

Regular visits for optimization and monitoring

Post-Surgical Testing

Post-surgical testing with HD-DOT and cognitive assessments in ON and OFF DBS states

4-8 weeks

Multiple visits for testing in different DBS states

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STN DBS

Trial Overview The study tests how STN DBS affects cortical networks related to movement and cognition using HD-DOT scanning technology. This could improve DBS clinical optimization and identify new targets for neuromodulation therapy. Participants will undergo motor/cognitive tests, questionnaires, HD-DOT scans, and MRIs.

How Is the Trial Designed?

Group I: Post-Surgical Group Experimental Treatment 1 Intervention

STN DBS: Subjects with PD and DBS STN implanted will be scanned and tested with DBS ON and OFF

STN DBS is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as STN DBS for:

• Parkinson's Disease

Approved in United States as STN DBS for:

• Parkinson's Disease

Approved in Canada as STN DBS for:

• Parkinson's Disease

Approved in Japan as STN DBS for:

• Parkinson's Disease

Approved in China as STN DBS for:

• Parkinson's Disease

Approved in Switzerland as STN DBS for:

• Parkinson's Disease

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Subthalamic nucleus deep brain stimulation (STN DBS) is safe and effective for improving motor function in patients aged 75 and older, showing similar benefits to younger patients after one year.

Both older and younger cohorts experienced significant improvements in motor function as measured by the Unified Parkinson Disease Rating Scale (UPDRS III), with low complication rates and no significant difference in outcomes between the two age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Subthalamic Nucleus Deep Brain Stimulation in Elderly Patients With Parkinson Disease: A Case-Control Study. Mitchell, KT., Younce, JR., Norris, SA., et al.[2021]

In a study of 81 Parkinson's disease patients who underwent deep brain stimulation (DBS) surgery, violating the lateral ventricle during the procedure was significantly associated with postoperative confusion, with a relative risk of 87 (P < .001).

Out of 145 leads implanted, 8 patients experienced confusion and longer hospital stays, and all of these cases had evidence of ventricular wall violation on MRI, suggesting that this complication may contribute to cognitive issues more commonly seen in STN DBS compared to other targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transgressing the ventricular wall during subthalamic deep brain stimulation surgery for Parkinson disease increases the risk of adverse neurological sequelae. Gologorsky, Y., Ben-Haim, S., Moshier, EL., et al.[2011]

In a study of 52 patients with advanced Parkinson's disease followed for over 3 years, subthalamic nucleus deep brain stimulation (STN DBS) was found to significantly improve motor function, particularly in relation to preoperative levodopa response.

Preoperative activity of daily living (ADL) and levodopa equivalent dose (LED) were identified as strong predictors of improvement in daily functioning after STN DBS, highlighting the importance of these factors in determining treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors related to outcomes of subthalamic deep brain stimulation in Parkinson's disease. Kim, HY., Chang, WS., Kang, DW., et al.[2021]

Patients with Parkinson's disease who underwent deep brain stimulation (STN-DBS) experienced improved motor function and reduced medication dosage in the first year after surgery, while nonmotor symptoms and cognition remained stable.

STN-DBS patients had a delayed onset of morbidity milestones (like falls and dementia) compared to those receiving medical treatment alone, suggesting that while they may live longer with the disease, significant health declines occur in the last 5 years of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity Milestones Demonstrate Long Disability-Free Survival in Parkinson's Disease Patients with Deep Brain Stimulation of the Subthalamic Nucleus. Schnalke, N., Konitsioti, A., Frank, A., et al.[2023]

This study involved 30 Parkinson's disease patients and explored how magnetoencephalography (MEG) can help identify the best stimulation contact point in deep brain stimulation (DBS) of the subthalamic nucleus (STN) by measuring changes in brain activity.

Results showed that more dorsolateral stimulation led to lower low-beta power in the motor cortex, while ventromedial stimulation increased whole-brain delta and theta power, indicating that the contact point affects brain activity, but individual responses varied significantly, making it unclear if MEG can reliably guide optimal DBS settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetoencephalography to measure the effect of contact point-specific deep brain stimulation in Parkinson's disease: A proof of concept study. Boon, LI., Potters, WV., Hillebrand, A., et al.[2023]

In a study of 66 patients with Parkinson's disease treated with subthalamic nucleus deep brain stimulation (STN DBS), there was a significant average reduction of 45% in motor symptoms as measured by the UPDRS III score six months post-implantation.

STN DBS also led to a notable decrease in levodopa consumption, with reductions ranging from 15% to 100%, indicating its potential to enhance treatment efficacy while possibly reducing medication dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthalamic deep brain stimulation for the treatment of Parkinson disease. Mandat, T., Tykocki, T., Koziara, H., et al.[2019]

In a study of 233 Parkinson's Disease patients who underwent Deep Brain Stimulation (DBS) of the subthalamic nucleus, only 11.76% of procedures resulted in surgical adverse events (SAEs), indicating a relatively low risk associated with the procedure.

Most SAEs were reversible, with only two cases leading to long-term effects, demonstrating that STN DBS is a safe surgical option with a high reliability rate of 95.59% for correct lead implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical adverse events of deep brain stimulation in the subthalamic nucleus of patients with Parkinson's disease. The learning curve and the pitfalls. Seijo, F., Alvarez de Eulate Beramendi, S., Santamarta Liébana, E., et al.[2022]

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) in patients with advanced Parkinson's disease showed significant long-term motor improvement, with a 66% enhancement in motor function maintained five years post-surgery.

While STN-DBS effectively improved motor symptoms, there was a notable decline in axial symptoms and an increase in dementia cases over five years, suggesting that while DBS is beneficial for motor control, its long-term effects on cognitive health and axial symptoms require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the subthalamic nucleus in advanced Parkinson's disease: five year follow-up at a Portuguese center. Monteiro, A., Andrade, C., Rosas, MJ., et al.[2014]

In a study of 49 patients with Parkinson's disease who underwent deep brain stimulation (DBS) surgery, 26.5% experienced postoperative confusion, highlighting a notable risk associated with this treatment.

The analysis revealed that a higher Charlson comorbidity index, which indicates the presence of other health conditions, was significantly linked to the development of confusion after surgery, suggesting that patients with more health issues may be at greater risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Confusion in Patients with Parkinson Disease Undergoing Deep Brain Stimulation of the Subthalamic Nucleus. Paim Strapasson, AC., Martins Antunes, ÁC., Petry Oppitz, P., et al.[2019]

In a study of 26 elderly patients with Parkinson's disease undergoing subthalamic deep brain stimulation (STN-DBS), there was a higher incidence of serious adverse events, particularly psychosis and hallucinations, compared to younger patients from the EARLYSTIM study.

Despite these psychiatric complications being transient, the overall benefits of STN-DBS in improving Parkinson's symptoms were found to outweigh the risks, highlighting the importance of thorough psychiatric evaluations before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. Cozac, VV., Ehrensperger, MM., Gschwandtner, U., et al.[2020]

Bilateral subthalamic nucleus deep brain stimulation (STN-DBS) was successfully applied to a 54-year-old man with early Parkinson's disease, showing improvements in motor function and quality of life over a two-year follow-up.

The participant experienced no serious adverse events, indicating that STN-DBS may be a safe intervention for early-stage Parkinson's disease, although his medication dosage increased during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for early-stage Parkinson's disease: an illustrative case. Gill, CE., Allen, LA., Konrad, PE., et al.[2022]

In a study of 98 patients with advanced Parkinson's disease, 29.6% were deemed unsuitable for Deep Brain Stimulation (DBS) surgery, highlighting the need for careful patient selection.

The most common reasons for exclusion included neuropsychological disorders (48.3%) and insufficient motor disability (37.9%), indicating that both mental health and the severity of physical symptoms are critical factors in determining candidacy for DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the subthalamic nucleus in PD: an analysis of the exclusion causes. Lopiano, L., Rizzone, M., Bergamasco, B., et al.[2019]

Citations

1. 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16892449/

Subthalamic nucleus deep brain stimulation: summary and ... However, a recent summary of clinical evidence on the effectiveness of STN DBS is lacking. We report the results of such a systematic review and meta-analysis.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28505983/

Subthalamic Nucleus Deep Brain Stimulation in ... Subthalamic Nucleus Deep Brain Stimulation (STN DBS) is a well-established and effective treatment modality for selected patients with Parkinson's disease (PD).

4. nature.com nature.com/articles/s41531-019-0089-1

Outcomes from deep brain stimulation targeting ... Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is effective in improving the motor complications of Parkinson's disease (PD) and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S294966912300009X

Deep brain stimulation of the subthalamic nucleus in ... Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a proven effective and safe method for patients with Parkinson's disease (PD).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40952750/

Five-Year Outcomes from Deep Brain Stimulation of the ... Although STN-DBS outcomes declined slightly, possibly due to the progressive nature of the disease, patients with PD sustained significant ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17876242/

Safety and efficacy of subthalamic nucleus deep brain ... Results: Adverse effects were infrequent and transient with no incidence of death, hemiparesis, or seizure. In the 72 patients, STN DBS reduced total Unified ...

8. nature.com nature.com/articles/s41531-021-00223-5

Subthalamic and pallidal deep brain stimulation for ... STN-DBS improved dyskinesia by 64%, daily OFF time by 69.1%, and quality of life measured by PDQ-39 by 22.2%, while Levodopa Equivalent Daily Dose (LEDD) was ...