Not provided
Not provided
Not provided
Not provided
The study was stopped early due to insufficient staff to continue EEG data collection and analysis following the departure of key study personnel.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized DBS adjustments | Other | Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized DBS adjustments | Procedure | Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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' | 30-60 minutes after stimulation adjustment |
| Verbal Fluency | Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation' | 30-60 minutes after stimulation adjustment |
| Finger Tapping Speed | Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation' | 30-60 minutes after stimulation adjustment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
History of other central nervous system disease (excluding migraine),
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),
Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
Current alcohol or substance abuse,
Lack of fluency in English which would invalidate cognitive testing,
Hearing or visual impairment precluding cognitive testing.
Exclusion criteria for Day 2 procedures:
Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Darlene Floden, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Five participants were enrolled from 05/30/2018 to 11/04/2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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' | Posted | Count of Participants | Participants | 30-60 minutes after stimulation adjustment |
|
|
Adverse event data were collected for 2-3 days, depending on the number of study sessions, with monitoring by Clinical Research Unit (CRU) nursing staff and the research team. Participants were assessed for safety and well-being after each change in stimulation parameters during EEG recording and fMRI sessions as well as by telephone one day after their final study session.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Limitations of this trial include early termination due to a lack of eligible patients which led to a reduced sample size and limited data collection. This constraint impacted the statistical power and the ability to conduct complete analyses as initially planned. Additionally, technical limitations related to EEG data collection and analysis emerged, as key personnel responsible for EEG recording and data processing were unavailable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darlene Floden | Cleveland Clinic | 216-444-1298 | flodend@ccf.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2020 | Nov 11, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Verbal Fluency | Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation' | Patients with Deep Brain Stimulation Electrodes implanted to treat Parkinson's disease | Posted | Mean | Full Range | words | 30-60 minutes after stimulation adjustment |
|
|
|
| Primary | Finger Tapping Speed | Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation' | Posted | Mean | Full Range | finger taps | 30-60 minutes after stimulation adjustment |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |