Back to resultsfMRI Guided TMS Enhancement of Associative Memory Networks
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MagStim RapidStim2
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring cognitive dysfunction, memory loss, non-invasive transcranial magnetic stimulation (TMS), rTMS, Magstim Rapid2
Eligibility Criteria
Inclusion Criteria:
- Fluent in English
- Right-handed
- Score at least 26 out of 30 on the Montreal Cognitive Assessment (MOCA). Healthy subjects will be matched to age, handedness, and education compared to epilepsy subjects.
- Must be able to provide informed consent.
Exclusion Criteria:
- Any history of a neurological disorder
- Chronic or progressive medical condition
- Any history of severe traumatic brain injury or skull defect
- Metal or devices in the head, including neurostimulators of metal foreign bodies
- Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS.
- Any other ferromagnetic substance in the body (including tattoos, dental prosthetics, etc).
- Taking a medication which may lower the seizure threshold within the 4 weeks prior to the start of the study, including use of neuroleptic (esp. clozapine), antibiotic (penicillin, cephalosporins), and bronchodilating medications.
- Pregnancy
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Healthy Subjects
Temporal Lobe Epilepsy Patients
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02749422
Brief Title
fMRI Guided TMS Enhancement of Associative Memory Networks
Official Title
A Randomized Controlled Pilot Study of TMS Enhancement of Associative Memory Networks in Healthy Subjects and Epilepsy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2016 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
cognitive dysfunction, memory loss, non-invasive transcranial magnetic stimulation (TMS), rTMS, Magstim Rapid2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Subjects
Arm Type
Active Comparator
Arm Title
Temporal Lobe Epilepsy Patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
MagStim RapidStim2
Intervention Description
Repetitive transcranial magnetic stimulation (TMS)
Primary Outcome Measure Information:
Title
Mean Change in Face-Object Pair Association Task Score during Left Lateral Parietal Site Stimulation
Description
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.
Time Frame
Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
Title
Mean Change in Face-Object Pair Association Task Score during Motor Cortex Stimulation
Description
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.
Time Frame
Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
Secondary Outcome Measure Information:
Title
Change in fMRI-based Functional Connectivity between Hippocampus and Cortical Regions
Description
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.
Time Frame
Baseline, Week 6
Title
Mean Change in Word-Pair Association Task Score during Left Lateral Parietal Site Stimulation
Description
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.
Time Frame
Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
Title
Mean Change in Word-Pair Association Task Score during Motor Cortex Stimulation
Description
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.
Time Frame
Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fluent in English
Right-handed
Score at least 26 out of 30 on the Montreal Cognitive Assessment (MOCA). Healthy subjects will be matched to age, handedness, and education compared to epilepsy subjects.
Must be able to provide informed consent.
Exclusion Criteria:
Any history of a neurological disorder
Chronic or progressive medical condition
Any history of severe traumatic brain injury or skull defect
Metal or devices in the head, including neurostimulators of metal foreign bodies
Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS.
Any other ferromagnetic substance in the body (including tattoos, dental prosthetics, etc).
Taking a medication which may lower the seizure threshold within the 4 weeks prior to the start of the study, including use of neuroleptic (esp. clozapine), antibiotic (penicillin, cephalosporins), and bronchodilating medications.
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anli Liu, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.
Learn more about this trial
fMRI Guided TMS Enhancement of Associative Memory Networks
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