60 Participants Needed

Brain Stimulation for Parkinson's Disease

CC
EP
Overseen ByElvira Pirondini, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jorge Gonzalez-Martinez
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 explores how deep brain stimulation (DBS) can improve movement and speech in people with movement disorders like Parkinson's Disease. Researchers will test DBS effects during surgery by using special electrodes to observe changes in movement and brain activity. The goal is to understand DBS mechanisms and potentially improve treatment methods. The trial seeks participants with essential tremor or Parkinson's who are already scheduled for DBS surgery and have symptoms affecting one side more than the other.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

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's best to discuss this with the study team or your doctor.

What prior data suggests that this brain stimulation technique is safe for Parkinson's disease patients?

Research has shown that deep brain stimulation (DBS) is generally safe for people with Parkinson's disease. Studies have found that DBS can improve movement with fewer side effects than other treatments. For example, some individuals can reduce their medication doses after receiving DBS, indicating that the treatment is well-tolerated over time.

Similarly, direct cortical stimulation (DCS) is also considered safe. One review noted that while some individuals felt sensations under the electrodes, DCS remained a safe and manageable procedure.

Both treatments aim to address movement problems in Parkinson's disease, and current research supports their safety. However, discussing potential risks and benefits with a healthcare provider is important.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for Parkinson's disease because they offer a new approach to managing symptoms. Unlike standard treatments like medication and traditional deep brain stimulation, direct cortical stimulation and deep brain stimulation of the motor thalamus target specific brain areas more precisely. This precision could potentially improve movement control and reduce side effects related to speech and swallowing. These new methods aim to provide more effective and personalized treatment options for individuals with Parkinson's disease.

What evidence suggests that this trial's treatments could be effective for Parkinson's Disease?

Past studies have demonstrated that deep brain stimulation (DBS) effectively helps people with Parkinson's disease by reducing symptoms like tremors, slow movement, and muscle stiffness. Research shows that individuals with DBS often require less medication, improving their quality of life. In this trial, participants will receive either DBS of the motor thalamus or direct cortical stimulation. Direct cortical stimulation, which involves stimulating the brain's outer layer, has shown mixed results. Some studies found it aids thinking and movement, while others observed no significant change. Overall, both treatments hold potential, but direct cortical stimulation is less consistently effective than DBS.25678

Who Is on the Research Team?

JG

Jorge Gonzalez-Martinez, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for patients who are already scheduled to have deep brain stimulation (DBS) surgery for movement disorders like Parkinson's disease, essential tremor, or the effects of stroke or traumatic brain injury. Participants should be able to undergo additional testing with a temporary electrode during their DBS procedure.

Inclusion Criteria

Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment
I have Parkinson's and am scheduled for deep brain stimulation surgery at UPMC.
I am scheduled for deep brain stimulation at UPMC for my uneven essential tremor.

Exclusion Criteria

Patients with any seizure history
I have severe shaking in both hands that stops me from doing tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intra-operative Testing

Participants undergo deep brain stimulation implantation and intra-operative testing with direct cortical stimulation and recording of cortical and subcortical potentials.

1 day
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for motor and speech function improvements using electromyography and other assessments.

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Deep brain stimulation of motor thalamus
  • Direct cortical stimulation
Trial Overview The study tests how stimulating specific brain areas (VOP/VIM) affects movement and muscle control in patients receiving DBS implants. It involves extra recording and stimulation via a temporary cortical strip electrode during standard DBS implantation surgery.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Direct Cortical Stimulation and Deep Brain Stimulation of the Motor ThalamusExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jorge Gonzalez-Martinez

Lead Sponsor

Trials
1
Recruited
10+

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30660117/
Long-term outcomes following deep brain stimulation for ...Conclusions: DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36411150/
Quality of Life and Motor Outcomes in Patients With ...Deep brain stimulation (DBS) is effective in improving symptoms of diminished levodopa responsiveness. QoL improvements with DBS have been shown in several ...
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.
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 ...
Deep brain stimulation of symptom-specific networks in ...Deep Brain Stimulation can improve tremor, bradykinesia, rigidity, and axial symptoms in patients with Parkinson's disease.
Deep Brain Stimulation in Parkinson's Disease - PMCIn different randomized controlled trials DBS showed a better functional outcome with fewer side effects [Esselink et al. 2004; Schuurman et al. 2000] and ...
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.
Clinical Outcomes from Deep Brain Stimulation with ...At a mean follow-up of one-year post DBS implantation, MICC stimulation alone resulted in greater than 50% improvement in UPDRS motor scores.
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