Deep Brain Stimulation for Parkinson's Disease

Overseen By Sarah Bedell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Pregnancy, Claustrophobia, MRI contraindications, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 hours

20 Participants Needed

Trial Summary

What is the purpose of this trial?

More than one million people in the United States have Parkinson's disease (PD) and the prevalence is expected to double by 2040. Over 60% of these individuals will develop debilitating postural instability and gait disturbances (PIGD), including freezing of gait (FOG). With disease progression, axial motor symptoms typically become resistant to dopamine replacement therapies (e.g. levodopa) and a primary source of disability and morbidity. While subthalamic (STN) and globus pallidus internus (GPi) deep brain stimulation (DBS) using standard locations and stimulation parameters can be highly effective for the treatment of the cardinalmotorsymptomsof PD, both treatments often fail to control levodopa-resistant motor features of PD such as PIGD. DBS can also impair cognitive function which further exacerbates PIGD, particularly when the task requires attentional resources. Thus, despite considerable improvements in appendicular bradykinesia, rigidity and tremor with conventional DBS, the disease can continue to be dominated by PIGD, leading to increased falls, decreased mobility, and increased rate of hospitalization and morbidity. This is why one of the top NINDS priorities for clinical research in PD is the development of novel therapeutic approaches, such as DBS targeting, to treat levodopa-resistant motor symptoms. This study will provide crucial information to elucidate the functional properties of the networks involved in Deep Brain Stimulation (DBS) treatment. By refining our understanding of the neural networks involved in stimulation of DBS targets, we will improve our ability to program patients to enhance their clinical outcomes and minimize side effects.

Research Team

Noam Harel, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for individuals with Parkinson's Disease who experience postural instability and gait disturbances that don't improve with standard medications like levodopa. The study seeks to understand how deep brain stimulation (DBS) can better control these symptoms.

Inclusion Criteria

English speaking

I have a Medtronic Percept DBS device for Parkinson's.

I am 21 years old or older.

Exclusion Criteria

Implanted with a DBS device that is not MR compatible

Pregnant

Extreme claustrophobia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo functional MRI scanning with DBS cycling between ON and OFF stimulation to measure BOLD signal changes

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the MRI scanning procedure

4 weeks

Treatment Details

Interventions

• Bipolar DBS stimulation

Trial Overview The trial is testing the effects of bipolar DBS stimulation on patients with Parkinson's Disease, specifically targeting symptoms such as freezing of gait that are resistant to medication. It aims to refine techniques for stimulating neural networks to enhance patient outcomes.

Participant Groups

Group I: Study group Experimental Treatment 1 Intervention

2 Study Procedures: Patients who have been already implanted with a MRI compatible DBS device (Medtronic Percept / Percept RC™)

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+