NCT03702127

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jul 2019Jul 2026

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

July 16, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

June 12, 2025

Status Verified

May 1, 2025

Enrollment Period

7 years

First QC Date

October 8, 2018

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in brain activity assessed with intracranial EEG

    Activity changes within seconds of the stimulation

Study Arms (1)

TMS in patients with intracranial electrodes

EXPERIMENTAL

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.

Device: Transcranial magnetic stimulation

Interventions

NIBS is applied to the brain.

TMS in patients with intracranial electrodes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Aaron Boes, MD, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participant will receive active and sham stimulation at varying points during the study.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

July 16, 2019

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

June 12, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations