- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02749422
fMRI Guided TMS Enhancement of Associative Memory Networks
September 28, 2023 updated by: NYU Langone Health
A Randomized Controlled Pilot Study of TMS Enhancement of Associative Memory Networks in Healthy Subjects and Epilepsy Patients
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Subjects
|
Repetitive transcranial magnetic stimulation (TMS)
|
Experimental: Temporal Lobe Epilepsy Patients
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Repetitive transcranial magnetic stimulation (TMS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Face-Object Pair Association Task Score during Left Lateral Parietal Site Stimulation
Time Frame: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
|
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
Time Frame: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fMRI-based Functional Connectivity between Hippocampus and Cortical Regions
Time Frame: Baseline, Week 6
|
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
|
Mean Change in Word-Pair Association Task Score during Left Lateral Parietal Site Stimulation
Time Frame: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
|
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
Time Frame: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anli Liu, MD, New York University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2016
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
March 30, 2023
Study Registration Dates
First Submitted
April 13, 2016
First Submitted That Met QC Criteria
April 22, 2016
First Posted (Estimated)
April 25, 2016
Study Record Updates
Last Update Posted (Actual)
October 2, 2023
Last Update Submitted That Met QC Criteria
September 28, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-00732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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