Comparing neurostimulator settings for Parkinson's disease treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of two different neurostimulator settings on Parkinson's disease symptoms in patients receiving Deep Brain Stimulation (DBS) therapy. The settings are designed to activate distinct neuroanatomical pathways: one from the Globus Pallidus to the Pedunculopontine Nucleus, and the other from the Pedunculopontine Nucleus back to the Globus Pallidus. Participants will be monitored over two weeks to assess clinically relevant outcomes such as activities of daily living and quality of life. The goal is to determine which neurostimulator setting is more effective for addressing postural instability and gait disorders in Parkinson's patients.

Why it matters

Who can join: the full rules

* Diagnosis of Parkinson's Disease
* Bilateral DBS in STN or GP
* At least 3 months after lead implantation
* Montreal Cognitive Assessment (MoCA):

MoCA=23+

OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate.

* Between 18-85 years of age
* Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care).

8.2 Exclusion Criteria:

* Inability to walk in the off-med, off-stimulation condition (even with safety harness)
* Gait impaired significantly by a condition other than PD
* Breaks or shorts in active contacts
* IPG battery nearing end of life (in patients with primary-cell IPGs)
* Females who are nursing or pregnant

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Johanna Caskey, BA
• Email: caske039@umn.edu
• Phone: 763-353-9470

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MAO-B PET/CT imaging in Parkinson’s-related diseases

  This study tests whether 18F-FPyCO/SMBT-1 PET/CT can help diagnose Parkinson’s-related conditions by measuring lesion uptake in patients with PD, PD dementia, or parkinsonism.

  Recruiting at 3 sites Tianjin Medical University · Hefei, Anhui and 2 other locations · NCT07685873

• Sleep and DBS: Testing Deep Brain Stimulation Effects on Sleep in Parkinson’s

  This study tests how turning the Deep Brain Stimulation device on or off affects sleep quality in people with Parkinson’s who already have a DBS implant.

  Recruiting The University of Texas Health Science Center at San Antonio · San Antonio, Texas · NCT07636720

• Detecting phosphorylated alpha-synuclein in colon tissue to help diagnose Parkinson's

  This study will test whether routine colonoscopy tissue samples from adults with Parkinson's show phosphorylated alpha-synuclein, a protein linked to the disease.

  Recruiting CND Life Sciences · Portland, Oregon · NCT07204652

• tDCS to improve swallowing in Parkinson's disease

  This study tests whether adding transcranial direct current stimulation (tDCS) to standard swallowing therapy helps people with Parkinson's disease who have dysphagia.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07153692

• Investigating how deep brain stimulation affects sleep in Parkinson's disease

  This study is testing how deep brain stimulation affects sleep in people with Parkinson's disease to see if it can help improve their sleep quality.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT06914466

• Improving balance in Parkinson's disease using blood flow restriction

  This study is testing whether using blood flow restriction during balance exercises can help people with Parkinson's disease improve their walking, balance, and endurance.

  Recruiting The University of Texas Health Science Center at San Antonio · San Antonio, Texas · NCT06508801

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.