fMRI Guided TMS Enhancement of Associative Memory Networks

Epilepsy Clinical Trial

Official title:

A Randomized Controlled Pilot Study of TMS Enhancement of Associative Memory Networks in Healthy Subjects and Epilepsy Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02749422
• Other study ID #: 15-00732
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy

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)