Clinical trial NCT02749422: fMRI Guided TMS Enhancement of Associative Memory Networks
Official title: A Randomized Controlled Pilot Study of TMS Enhancement of Associative Memory Networks in Healthy Subjects and Epilepsy Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epilepsy
Keywords: cognitive dysfunction
memory loss
non-invasive transcranial magnetic stimulation (TMS)
rTMS
Magstim Rapid2
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation
timeFrame: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
measure: Mean Change in Face-Object Pair Association Task Score During Motor Cortex Stimulation
timeFrame: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
Secondary outcomes:
measure: Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions
timeFrame: Baseline, Week 6
measure: Mean Change in Word-Pair Association Task Score During Left Lateral Parietal Site Stimulation
timeFrame: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
measure: Mean Change in Word-Pair Association Task Score During Motor Cortex Stimulation
timeFrame: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Anli Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: