Understanding brain mechanisms for improved movement in Parkinson's disease
Intra-operative Recordings to Characterize Movement Facilitation in Parkinson's Disease
This study is testing how different cues can help improve movement in people with Parkinson's disease during brain surgery to find new ways to treat tough symptoms like freezing up while walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05166655 on ClinicalTrials.gov |
What this trial studies
This study investigates how different external cues can enhance movement in patients with Parkinson's disease during deep brain stimulation (DBS) surgery. Patients will perform specific movement tasks while their brain activity is recorded, allowing researchers to identify the neural networks involved in movement facilitation. The study aims to uncover biomarkers that could lead to new neuromodulation therapies for symptoms that are difficult to treat, such as freezing of gait. The research is conducted exclusively in the intraoperative setting, minimizing additional visits for participants.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with idiopathic Parkinson's disease who are undergoing deep brain stimulation surgery.
Not a fit: Patients who are not undergoing DBS surgery or have contraindications to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment strategies that significantly improve movement in patients with Parkinson's disease.
How similar studies have performed: Other studies have shown promise in using deep brain stimulation and external cues to improve movement in Parkinson's disease, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of idiopathic Parkinson's disease based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia) * Undergoing deep brain stimulation surgery for treatment of advanced Parkinson's disease, according to clinical evaluation, including the following criteria: * advanced idiopathic PD as determined by OFF unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale \> 25 * L-dopa responsive symptoms with at least 30% improvement in UPDRS III scores on vs. off medication OR medication refractory disabling tremor * Persistent disabling motor symptoms or drug side effects (dyskinesias, motor fluctuations, disabling "off" periods) despite optimal medical therapy * preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities * Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes Exclusion Criteria: * medical contraindication to surgery, including use of anticoagulant or antiplatelet therapy within 1 week * significant cognitive or psychiatric disease based on clinical neuropsychological testing
Where this trial is running
Los Angeles, California
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Katy Cross, MD, PhD
- Email: kcross@Mednet.ucla.edu
- Phone: 310-206-2828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.