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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 1 year into treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Swing Time Coefficient of Variation

Secondary outcome measures

Average + standard deviation of response time

Caregiver Burden Assessment

Distractibility

+25 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,579 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must individuals fulfill to become participants of this clinical research?

"To qualify for this clinical trial, potential patients must have a diagnosis of Parkinson's disease and be between 21-80 years old. This particular study is only looking to enroll around 10 participants."

Answered by AI

Are individuals aged 25 or above eligible for this clinical investigation?

"The minimum age of admission for this experiment is 21 while the maximum allowable age to participate is 80, per the criteria listed in its requirements."

Answered by AI

Is this study recruiting participants at the moment?

"The clinicaltrials.gov website indicates that this trial, first posted on October 1st 2023, is no longer recruiting patients at the present time. However there are still 1095 other medical studies actively searching for participants to join in their research."

Answered by AI

What is the prime purpose of this investigation?

"The primary focus of this year-long trial is to assess Swing Time Coefficient of Variation. Secondary observations include Stride Time Coefficient of Variation, Shank Angular Velocity and Tapping Speed. These are evaluated using dual force plates in the SIP task, IMUs work on participants' legs/ankles, as well as an engineered piano keyboard for interstrike-interval tapping speed measurement respectively. Reduction values indicate FOG and gait impairment while longer intervals suggest slower performance overall."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease

Helen M. Bronte-Stewart 2024. "Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05968703.

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