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This study was closed prematurely due to longer-than-expected recruitment times.
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This is a randomized, single-blinded, controlled phase 1 study to demonstrate feasibility and explore the neurophysiologic and clinical effects of repetitive transcranial magnetic stimulation (TMS) interventions in epilepsy patients and healthy controls. The inclusion of a control group will be used to see whether epilepsy patients, who suffer from a higher degree of comorbid memory difficulty presumably from entorhinal-hippocampal dysfunction, can benefit from a TMS intervention can benefit as much as a healthy matched population. Investigators will also be looking at functional connectivity between the hippocampus and cortical regions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Active Comparator |
| |
| Temporal Lobe Epilepsy Patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagStim RapidStim2 | Diagnostic Test | Repetitive transcranial magnetic stimulation (TMS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation | A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment. | Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6) |
| Mean Change in Face-Object Pair Association Task Score During Motor Cortex Stimulation | A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment. | Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions | Changes in hippocampal-cortical functional connectivity will be identified using voxel-wise paired T-tests. The change will be measured between baseline assessment and resting state fMRI assessment following rTMS. | Baseline, Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anli Liu, MD | New York University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal.
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No patients were enrolled in the Healthy Subjects arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Subjects | MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) |
| FG001 | Temporal Lobe Epilepsy Patients | MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No subjects were enrolled in the "Healthy Subject" study arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Subjects | MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) |
| BG001 | Temporal Lobe Epilepsy Patients | MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) |
| 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 | Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation | A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment. | Data for this outcome measure were not collected from participants in the study. | Posted | Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6) |
|
10 months
No subjects were enrolled in the "Healthy Subjects" arm; the number of participants at risk is zero for this arm.
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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 | Healthy Subjects | MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anli Liu | NYU Langone Health | 929-455-2340 | Anli.Liu@nyulangone.org |
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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 | Jun 6, 2017 | Apr 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003072 | Cognition Disorders |
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| Mean Change in Word-Pair Association Task Score During Left Lateral Parietal Site Stimulation |
A word-pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment. |
| Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6) |
| Mean Change in Word-Pair Association Task Score During Motor Cortex Stimulation | A word-pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment. | Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6) |
| BG002 | 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 |
|
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) |
|
| Primary | Mean Change in Face-Object Pair Association Task Score During Motor Cortex Stimulation | A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment. | Data for this outcome measure were not collected from participants in the study. | Posted | Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6) |
|
|
| Secondary | Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions | Changes in hippocampal-cortical functional connectivity will be identified using voxel-wise paired T-tests. The change will be measured between baseline assessment and resting state fMRI assessment following rTMS. | Data for this outcome measure were not collected from participants in the study. | Posted | Baseline, Week 6 |
|
|
| Secondary | Mean Change in Word-Pair Association Task Score During Left Lateral Parietal Site Stimulation | A word-pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment. | Data for this outcome measure were not collected from participants in the study. | Posted | Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6) |
|
|
| Secondary | Mean Change in Word-Pair Association Task Score During Motor Cortex Stimulation | A word-pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment. | Data for this outcome measure were not collected from participants in the study. | Posted | Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Temporal Lobe Epilepsy Patients | MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) | 0 | 5 | 0 | 5 | 0 | 5 |
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| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |