fMRI Guided TMS Enhancement of Associative Memory Networks

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NYU Langone Health

Status

Completed

Conditions

Epilepsy

Treatments

Diagnostic Test: MagStim RapidStim2

Study type

Interventional

Funder types

Other

Identifiers

NCT02749422
15-00732

Details and patient eligibility

About

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

Enrollment

2 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2 participants in 2 patient groups

Healthy Subjects
Active Comparator group
Treatment:
Diagnostic Test: MagStim RapidStim2
Temporal Lobe Epilepsy Patients
Experimental group
Treatment:
Diagnostic Test: MagStim RapidStim2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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