fMRI Guided TMS Enhancement of Associative Memory Networks

NCT02749422 | Terminated Results DMC FDA Device

• 1 other identifier: 15-00732
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

cognitive dysfunction; memory loss; non-invasive transcranial magnetic stimulation (TMS); rTMS; Magstim Rapid2

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions

  Baseline, Week 6

• 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)

• 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)

Study Arms (2)

Healthy Subjects

ACTIVE COMPARATOR

Diagnostic Test: MagStim RapidStim2

Temporal Lobe Epilepsy Patients

EXPERIMENTAL

Diagnostic Test: MagStim RapidStim2

Interventions

MagStim RapidStim2 DIAGNOSTIC_TEST

Repetitive transcranial magnetic stimulation (TMS)

Healthy Subjects; Temporal Lobe Epilepsy Patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy; Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anli Liu
• Organization: NYU Langone Health

Anli.Liu@nyulangone.org

929-455-2340

Study Officials

• Anli Liu, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 25, 2016
• Study Start: October 14, 2016
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)