No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Helen M. Bronte-Stewart · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who have mild cognitive impairment. Participants will receive a special type of brain stimulation over two years to help with thinking and movement problems.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease
I am approved or planning to have deep brain stimulation
You may not be able to join if
I have dementia
I have unstable medical or psychiatric conditions
I have a history of seizures
I am pregnant
I require MRI
I cannot walk 100 feet without an assistive device
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is:
Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS…
The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is:
Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.
Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of Parkinson's disease (PD)
* Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)
* Willingness to withdraw from clinical medication regimen when necessary for research visits
* Ability to provide informed consent
Exclusion Criteria:…
Inclusion Criteria:
* Diagnosis of Parkinson's disease (PD)
* Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)
* Willingness to withdraw from clinical medication regimen when necessary for research visits
* Ability to provide informed consent
Exclusion Criteria:
* Dementia
* Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation
* History of seizures
* Pregnant
* Requires MRI
* Unable to walk 100 feet without an assistive device
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