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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23NS099478-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals with Parkinson's Disease: A functional MRI investigation.
This project will examine the effect of functional MRI-based neurofeedback on brain plasticity and motor performance in patients with Parkinson's Disease (PD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PD neurofeedback training | Experimental | Patients will receive neurofeedback training. |
|
| Patients with PD control | Active Comparator | Patients will not receive neurofeedback training. |
|
| Patients with PD | No Intervention | Patients perform mental imagery (motor and visual aspects combined) in the MRI scanner without neurofeedback training. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD neurofeedback | Other | PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Right Insula-dorsomedial Frontal Cortex Functional Connectivity Strength. | The functional connectivity strength between the subjects' right insula and dorsomedial frontal cortex will be measured at baseline and post-intervention as each group of subjects engages in their respective imagery tasks. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions. | 4-6 weeks |
| Change in Resting-state Functional Connectivity Between the Right Insula and Dorsomedial Frontal Cortex. | We will obtain resting-state functional MRI scans from the PD-neurofeedback and PD-control groups at baseline and post-intervention to examine the changes in intrinsic functional connectivity between the right insula and dorsomedial frontal cortex. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions. | 4-6 weeks |
| Change in Motor Impairment | We will administer the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor exam) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor impairment. The MDS-UPDRS part III is a subscale that provides an objective assessment of motor impairment. The scores range between 0-132. Higher scores indicate more severe impairment. | Baseline and 4-6 weeks |
| Change in Motor Function | We will administer standard motor function tests (e.g., timed up and go, 5 times sit-to-stand, 360-degree turn) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor function. The performance score on these tests is the time to complete the motor tasks. Shorter time indicates better performance. The motor function tests measure movement speed. Timed up and go test measures (seconds) how fast one can stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down again. Five times sit-to-stand test measures (seconds) how fast one can stand up from a chair with arms crossed across the chest and sit back again 5 times in a row. 360-degree turn test measures (seconds) how fast one can turn around their own axis clockwise and counterclockwise. The composite motor function score is the sum of the durations (seconds) of all three tests. |
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| Measure | Description | Time Frame |
|---|---|---|
| Task-based Functional Connectivity | In a group of PD patients who will not receive any intervention, we will collect functional MRI data during a mental imagery task with both motor and visual imagery components to investigate the functional connectivity between the motor and visual networks. | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sule Tinaz, MD, Phd | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With PD Neurofeedback Training | Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks. |
| FG001 | Patients With PD Control | Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks. |
| FG002 | Patients With PD | Patients perform mental imagery (motor and visual aspects combined) in the MRI scanner without neurofeedback training. This was a small pilot arm with no intervention conducted after the completion of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants included in the complete case analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With PD Neurofeedback Training | Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Right Insula-dorsomedial Frontal Cortex Functional Connectivity Strength. | The functional connectivity strength between the subjects' right insula and dorsomedial frontal cortex will be measured at baseline and post-intervention as each group of subjects engages in their respective imagery tasks. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions. | Complete case analyses and participants in the pilot PD arm did not have these data collected. | Posted | Mean | Standard Error | percent change from baseline | 4-6 weeks |
|
Up to 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With PD Neurofeedback Training | Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sule Tinaz, MD, PhD: Associate Professor of Neurology | Yale School of Medicine | (877) 925-3637 | sule.tinaz@yale.edu |
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| 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 | Apr 19, 2022 | Jul 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2022 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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double blinded
|
| PD control | Other | PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks. |
|
| Baseline and 4-6 weeks |
| Lost to Follow-up |
|
| COVID-19 |
|
| BG001 | Patients With PD Control | Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks. |
| BG002 | Patients With PD | Patients perform mental imagery (motor and visual aspects combined) in the MRI scanner without neurofeedback training. This was a small pilot arm with no intervention conducted after the completion of the study. |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| OG001 | Patients With PD Control | Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks. |
|
|
|
| Primary | Change in Resting-state Functional Connectivity Between the Right Insula and Dorsomedial Frontal Cortex. | We will obtain resting-state functional MRI scans from the PD-neurofeedback and PD-control groups at baseline and post-intervention to examine the changes in intrinsic functional connectivity between the right insula and dorsomedial frontal cortex. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions. | Complete case analyses and participants in the pilot PD arm did not have these data collected. | Posted | Mean | Standard Error | percent change from baseline | 4-6 weeks |
|
|
|
|
| Primary | Change in Motor Impairment | We will administer the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor exam) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor impairment. The MDS-UPDRS part III is a subscale that provides an objective assessment of motor impairment. The scores range between 0-132. Higher scores indicate more severe impairment. | Complete case analyses and participants in the pilot PD arm did not have these data collected. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4-6 weeks |
|
|
|
|
| Primary | Change in Motor Function | We will administer standard motor function tests (e.g., timed up and go, 5 times sit-to-stand, 360-degree turn) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor function. The performance score on these tests is the time to complete the motor tasks. Shorter time indicates better performance. The motor function tests measure movement speed. Timed up and go test measures (seconds) how fast one can stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down again. Five times sit-to-stand test measures (seconds) how fast one can stand up from a chair with arms crossed across the chest and sit back again 5 times in a row. 360-degree turn test measures (seconds) how fast one can turn around their own axis clockwise and counterclockwise. The composite motor function score is the sum of the durations (seconds) of all three tests. | Complete case analyses and participants in the pilot PD arm did not have these data collected. | Posted | Mean | Standard Deviation | seconds | Baseline and 4-6 weeks |
|
|
|
|
| Other Pre-specified | Task-based Functional Connectivity | In a group of PD patients who will not receive any intervention, we will collect functional MRI data during a mental imagery task with both motor and visual imagery components to investigate the functional connectivity between the motor and visual networks. | Not Posted | 1 day | Participants |
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Patients With PD Control | Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Patients With PD | Patients perform mental imagery (motor and visual aspects combined) in the MRI scanner without neurofeedback training. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |