fMRI Guided TMS Enhancement of Associative Memory Networks

NCT ID: NCT02749422

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-14
• Study Completion Date: 2023-03-30

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

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Healthy Subjects

Group Type: ACTIVE_COMPARATOR

MagStim RapidStim2

Intervention Type: DIAGNOSTIC_TEST

Repetitive transcranial magnetic stimulation (TMS)

Temporal Lobe Epilepsy Patients

Group Type: EXPERIMENTAL

MagStim RapidStim2

Intervention Type: DIAGNOSTIC_TEST

Repetitive transcranial magnetic stimulation (TMS)

Interventions

MagStim RapidStim2

Repetitive transcranial magnetic stimulation (TMS)

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anli Liu, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-00732

Identifier Type: -

Identifier Source: org_study_id