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NIBS - Intracranial Electrodes

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ClinicalTrials.gov Identifier: NCT03702127
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Aaron Boes, University of Iowa

Brief Summary:
This is a study looking at the effects of non-invasive brain stimulation (NIBS) on the human brain as recorded by intracranial electroencephalography in neurosurgical patients. NIBS will be applied in a targeted manner and brain responses will be recorded.

Condition or disease Intervention/treatment Phase
Epilepsy Intractable Device: Transcranial magnetic stimulation; transcranial direct current stimulation; multimodal stimulation Not Applicable

Detailed Description:
In the last few years, non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS), transcranial current stimulation, and peripheral multi-modal stimulation have shown widespread clinical applications. Transcranial magnetic stimulation (TMS) is a noninvasive method of focally stimulating the brain that uses electromagnetic induction and does not require surgery. There is optimism that TMS and other forms of NIBS will revolutionize how we treat neurological and psychiatric disorders, evidenced by over 1000 clinical trials registered using TMS. Much of this optimism stems from the successful use of TMS as a treatment for depression. Despite the large number of clinical trials using NIBS the number of therapeutic indications has been stagnant, limited to major depression and more recently obsessive-compulsive disorder. There are fundamental questions about the underlying mechanisms of action for NIBS that will be critical to understand in order to advance this treatment modality. Here, we propose a unique collaborative project between neurology and neurosurgery that will allow an unprecedented window into understanding how NIBS impacts the human brain. Specifically, we will perform various forms of targeted NIBS in neurosurgical patients with intracranial electroencephalography (iEEG) monitoring to record real time effects of NIBS on local and remote brain areas with an unparalleled combination of spatial and temporal resolution relative to other human studies. TMS may present the most risk for patients with intracranial electrodes and we have already demonstrated the safety of this approach using a gel-based phantom brain and have results from seven patients demonstrating safety and preliminary results. For the current proposal we aim to: 1) characterize the response of NIBS on the human brain as recorded from iEEG between active and sham conditions, and 2) relate remote electrophysiological responses from NIBS to measures of brain connectivity between the stimulation & recording sites assessed with resting state functional connectivity MRI (rs-fcMRI). This will allow us to evaluate the relationship between NIBS-evoked iEEG responses and the strength of functional connectivity to the stimulation site in a regression model. For the TMS portion of the study we hypothesize that 1) TMS will have focal effects detected from surface electrodes underlying the stimulation site as well as network-level engagement detected at remote sites, 2) Repetitive TMS will induce frequency-specific effects that differ between 0.5 and 10 Hz stimulation protocols, and 3) the magnitude of repetitive TMS-evoked iEEG responses across electrodes will relate to the strength of rs-fcMRI between the stimulation and recording sites. By investigating the electrophysiological responses of TMS with high spatiotemporal precision in humans, this study will provide new mechanistic insights into the effects of TMS on target engagement and relate these findings to imaging methods already in widespread use. Moreover, the TMS will be applied in a clinically meaningful way by targeting the left dorsolateral prefrontal cortex in a protocol used to treat depression. Generating results for these aims will be key to advancing our understanding of how TMS and other forms of NIBS engage brain networks, which can be leveraged to rationally develop personalized, imaging-guided therapeutic NIBS for depression and other disorders.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Participant will receive active and sham stimulation at varying points during the study.
Primary Purpose: Basic Science
Official Title: Investigating Network Dynamics Using Non-invasive Brain Stimulation in Patients With Intracranial Electrodes
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NIBS in patients with intracranial electrodes
We will administer NIBS to neurosurgical patients with intracranial electroencephalography in order to better understand the effects NIBS has on the human brain. Participants will receive both active and sham stimulation at varying points during the study.
Device: Transcranial magnetic stimulation; transcranial direct current stimulation; multimodal stimulation
NIBS is applied to the brain.




Primary Outcome Measures :
  1. Change in brain activity assessed with intracranial EEG [ Time Frame: Activity changes within seconds of the stimulation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible subjects will include neurosurgery patients (age 18 - 75) who have implantation of intracranial electrodes and undergo long term (about 2 weeks) EEG monitoring in order to decide candidacy for surgical resection of seizure foci. They must have the cognitive capacity to understand the risks and benefits fo the study and provide consent.

Exclusion Criteria:

Those who are known to have neurological or psychiatric disorder other than primary disease for which patients have surgery will be excluded.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702127


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Aaron Boes
Investigators
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Principal Investigator: Aaron Boes, MD, PhD University of Iowa

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Responsible Party: Aaron Boes, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03702127     History of Changes
Other Study ID Numbers: 201707763
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Drug Resistant Epilepsy
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases