NCT04605263Enrolling by invitation
Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN)
Effects of Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) on Gait, Postural Stability, Freezing of Gait (FOG), and Falls
Source: ClinicalTrials.gov · Last updated 29 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a mechanistic study to determine the differential effects of the dopaminergic and cholinergic systems on attention, gait, and balance. The primary goal of the study is to evaluate the relative effects of pedunculopontine nucleus (PPN) and subthalamic nucleus (STN) Deep Brain Stimulation (DBS) on these features in persons with Parkinson's Disease (PD) who are eligible for DBS for improvement of their motor symptoms and exhibit gait instability with falls. Patients will be enrolled and implanted with bilateral electrodes in one of the approved DBS locations (subthalamic nucleus: STN), but additionally electrodes will be inserted into the experimental target, namely the PPN bilaterally.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 31 Aug 2020
- Start date
- 1 Nov 2021
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Diseases
- Parkinson disease
- NCT number
- NCT04605263
What you commit to
- Study type: Interventional
- Planned participants: 8
- From 1 Nov 2021 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have made a suicide attempt within the prior year,
Other illness
- Dementia per DSM-V criteria
- Condition precluding MRI
- History of supraspinal CNS disease other than PD
- History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
- Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
- Subjects with a history of seizure disorder
- Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
- Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
- Patient that is unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
Other
- Subjects who are pregnant or nursing.
- Any other reasons that, in the opinion of the investigator, the candidate is determined to be unsuitable for entry into the study.
Who the study is looking for
- Inclusion Criteria
- Informed consent signed by the subject.
- Diagnosed with Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria for at least 4 years
- Demonstrates levodopa responsiveness of at least 30%
- Experiences tremor or motor complications including wearing off and/or dyskinesia
- DBS candidate per FDA guidelines as outlined in criteria 2-4
- Candidate for STN targeting per the consensus committee
- Subject exhibits gait instability, or a history of at least one fall within the last year, or a history of falls on tests of Static or Dynamic Stability.
- PD Stage 2-3 with predominant axial symptoms or FOG refractory to Levodopa \> 600 mg and UPDRS Part III Subscore of \>6.
- Subject is ambulatory and able to walk for limited periods of time without using an assistive device.
- 18-75 years of age
- Primary English speaking
- Physically and cognitively capable of completing evaluations and consent
- Medically cleared for surgery and anesthesia
- Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Joseph's Hospital & Medical Center / Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.