- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03702127
TMS - Intracranial Electrodes
July 14, 2023 updated by: Aaron Boes
Investigating the Effects of Transcranial Magnetic Stimulation With Intracranial EEG in Humans
This is a study looking at the effects of transcranial magnetic stimulation (TMS), a form 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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 TMS 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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Eligible subjects will include neurosurgery patients (age 18 and above) 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TMS in patients with intracranial electrodes
We will administer TMS to neurosurgical patients with intracranial electroencephalography in order to better understand the effects TMS has on the human brain.
Participants will receive both active and sham stimulation at varying points during the study.
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NIBS is applied to the brain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in brain activity assessed with intracranial EEG
Time Frame: Activity changes within seconds of the stimulation
|
Activity changes within seconds of the stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron Boes, MD, PhD, University of Iowa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2019
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
October 8, 2018
First Submitted That Met QC Criteria
October 8, 2018
First Posted (Actual)
October 10, 2018
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 14, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201707763
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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