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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02749422
Other study ID # 15-00732
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 14, 2016
Est. completion date March 30, 2023

Study information

Verified date May 2024
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MagStim RapidStim2
Repetitive transcranial magnetic stimulation (TMS)

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
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. 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. 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. 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. Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
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