Deep Brain Stimulation, Parkinson's Disease
Conditions
Brief summary
Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.
Interventions
DEVICEDeep brain stimulation
Study will be utilizing multiple brain electrodes simultaneously. The study will require at least two electrodes to be placed in one cerebral hemisphere (one for motor improvement and one for potential cognitive implications).
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* All patients will be enrolled from the practice of the primary investigator. * Parkinson's Disease (PD) patients in whom optimal medical therapy has failed. * All patients will have responsivity to levodopa. * Individuals with normal or mild cognitive impairment.
Exclusion criteria
* Clinically significant dementia * Other significant neurological or psychiatric disease * Previous brain surgery including pallidotomy or thalamotomy * Previous placement of other implantable devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Memory Testing From Presurgical Baseline to 12 Months | baseline, 12 months | Memory will be assessed with the Hopkins Verbal Learning Test. The test consists of a set of six forms. Each test includes a list of 12 nouns; the examiner reads the list to the examinee, who repeats as many words as remembered. This process is repeated three times; 20-25 minutes later, examinees are asked again to recall as many words as possible; for the final task, the examiner reads a list of 24 words (including the 12 words from the list) and asks the examinee after each whether the word was on the list. For interpreting findings, in each metric listed on a scale from 0 to 12 with zero being worse and 12 being best (total recall, delayed recall, retention), higher scores reflect better learning efficiency (total recall) and memory (delayed recall, retention). Since this is a longitudinal study, follow-up scores will be compared to baseline. A positive direction of change would be interpreted as improved and a negative direction of change would be interpreted as declined. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deep Brain Stimulation Parkinson's disease subjects with dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Deep Brain Stimulation | — |
|---|---|---|
| Age, Customized | 61.2 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 5 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
| Unified Parkinson's Disease Rating Scale | 24 units on a scale | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 5 |
| other Total, other adverse events | 3 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
Change in Memory Testing From Presurgical Baseline to 12 Months
Memory will be assessed with the Hopkins Verbal Learning Test. The test consists of a set of six forms. Each test includes a list of 12 nouns; the examiner reads the list to the examinee, who repeats as many words as remembered. This process is repeated three times; 20-25 minutes later, examinees are asked again to recall as many words as possible; for the final task, the examiner reads a list of 24 words (including the 12 words from the list) and asks the examinee after each whether the word was on the list. For interpreting findings, in each metric listed on a scale from 0 to 12 with zero being worse and 12 being best (total recall, delayed recall, retention), higher scores reflect better learning efficiency (total recall) and memory (delayed recall, retention). Since this is a longitudinal study, follow-up scores will be compared to baseline. A positive direction of change would be interpreted as improved and a negative direction of change would be interpreted as declined.
Time frame: baseline, 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Deep Brain Stimulation | Change in Memory Testing From Presurgical Baseline to 12 Months | 1 score on a scale |