Parkinson Disease
Conditions
Brief summary
This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).
Detailed description
Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.
Interventions
PROCEDUREPersonalized DBS adjustments
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Sponsors
Darlene Floden
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Between 40 and 70 years of age, 2. Ability to provide informed consent, 3. Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist, 4. Disease duration of at least 4 years, 5. Treated with bilateral STN DBS for at least 3 months prior to study enrollment.
Exclusion criteria
1. History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy) 2. History of other central nervous system disease (excluding migraine), 3. Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19), 4. Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation, 5. Current alcohol or substance abuse, 6. Lack of fluency in English which would invalidate cognitive testing, 7. Hearing or visual impairment precluding cognitive testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reaction Time | 30-60 minutes after stimulation adjustment | Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation' |
| Verbal Fluency | 30-60 minutes after stimulation adjustment | Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation' |
| Finger Tapping Speed | 30-60 minutes after stimulation adjustment | Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation' |
Countries
United States
Participant flow
Recruitment details
Five participants were enrolled from 05/30/2018 to 11/04/2019.
Pre-assignment details
Following enrollment, participants completed a washout period by withholding Parkinson's medications overnight before each study session to reduce confounding effects. EEG electrodes were then applied prior to cognitive and motor testing under varied deep brain stimulation (DBS) parameters. No participants were excluded after enrollment. Key personnel changes led to early study closure, limiting the final data collection.
Participants by arm
| Arm | Count |
|---|---|
| Personalized DBS Adjustments Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Personalized DBS adjustments: Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Personalized DBS Adjustments |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 1.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Finger Tapping Speed
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'
Time frame: 30-60 minutes after stimulation adjustment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized DBS Adjustments | Finger Tapping Speed | Taps change at Dorsal High Hz | 2.1 finger taps |
| Personalized DBS Adjustments | Finger Tapping Speed | Taps change at Ventral Low Hz | 2.2 finger taps |
Primary
Reaction Time
Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
Time frame: 30-60 minutes after stimulation adjustment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Personalized DBS Adjustments | Reaction Time | Inhibitory control worse with Ventral High Hz | 2 Participants |
| Personalized DBS Adjustments | Reaction Time | Inhibitory control worse with Dorsal Low Hz | 1 Participants |
Primary
Verbal Fluency
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
Time frame: 30-60 minutes after stimulation adjustment
Population: Patients with Deep Brain Stimulation Electrodes implanted to treat Parkinson's disease
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized DBS Adjustments | Verbal Fluency | Change at Dorsal High Hz | 6.3 words |
| Personalized DBS Adjustments | Verbal Fluency | Change at Ventral Low Hz | -0.3 words |