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Deep Brain Stimulation

STN+NBM DBS for Mild Cognitive Impairment in Parkinson's Disease

N/A
Recruiting
Led By Helen M Bronte-Stewart, MD MSE
Research Sponsored by Helen M. Bronte-Stewart
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 1 year into treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the safety and tolerability of a novel deep brain stimulation approach targeting the STN and NBM to treat cognitive and cognitive-motor symptoms in Parkinson's patients with Mild Cognitive Impairment.

Who is the study for?
This trial is for individuals with Parkinson's disease who have mild cognitive impairment. They must be willing to adjust their medication for research visits, able to consent, approved for STN DBS surgery, and can walk 100 feet without help. It excludes pregnant individuals, those with unstable conditions or significant depression, dementia, a history of seizures, or the need for MRI.
What is being tested?
The study tests a new deep brain stimulation method combining STN and NBM targeting both motor and cognitive symptoms in Parkinson's patients. Ten participants will receive this treatment over two years with regular assessments using neuropsychological evaluations and motor tasks.
What are the potential side effects?
Potential side effects may include discomfort from the device implantation procedure, headache or dizziness post-surgery, temporary confusion or speech issues due to stimulation adjustments. Long-term risks are not fully known but could involve changes in mood or cognition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 1 year into treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1 year into treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Swing Time Coefficient of Variation
Secondary study objectives
Average + standard deviation of response time
Caregiver Burden Assessment
Distractibility
+25 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Vertical Nuclear TrajectoryExperimental Treatment1 Intervention
Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a vertical trajectory targeting the nucleus itself.
Group II: Lateral NBM Bundle TrajectoryExperimental Treatment1 Intervention
Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a lateral trajectory targeting the lateral efferent bundle from the NBM

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,377 Previous Clinical Trials
651,827 Total Patients Enrolled
Helen M. Bronte-StewartLead Sponsor
Helen M Bronte-Stewart, MD MSEPrincipal InvestigatorStanford University

Media Library

Combined STN+NBM DBS (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05968703 — N/A
Mild Cognitive Impairment Research Study Groups: Lateral NBM Bundle Trajectory, Vertical Nuclear Trajectory
Mild Cognitive Impairment Clinical Trial 2023: Combined STN+NBM DBS Highlights & Side Effects. Trial Name: NCT05968703 — N/A
Combined STN+NBM DBS (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05968703 — N/A
~7 spots leftby Aug 2027
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