fMRI Guided TMS Enhancement of Associative Memory Networks

Not Applicable

Terminated

• Conditions: Epilepsy
• Interventions: Diagnostic Test: MagStim RapidStim2

• Registration Number: NCT02749422
• Lead Sponsor: NYU Langone Health

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Study Start: 2016-10-14
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Results First Submitted: 2024-04-09
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Results First Posted: 2024-05-29
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	MagStim RapidStim2	-
Temporal Lobe Epilepsy Patients	MagStim RapidStim2	-

Primary Outcome Measures

Name	Time	Method
Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation	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.
Mean Change in Face-Object Pair Association Task Score During Motor Cortex Stimulation	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.

Secondary Outcome Measures

Name	Time	Method
Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions	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.
Mean Change in Word-Pair Association Task Score During Left Lateral Parietal Site Stimulation	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.
Mean Change in Word-Pair Association Task Score During Motor Cortex Stimulation	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States