TMS-EEG for Cortical Excitability

NCT ID: NCT05472363

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-07-01

Brief Summary

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This research study is being done to look at the safety and diagnostic benefit of conducting an TMS(transcranial magnetic stimulation)-EEG measured before and after a brief experimental stimulation session using investigational devices repetitive TMS or transcranial direct current stimulation (tDCS).

Detailed Description

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Conditions

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Acquired Brain Injury Stroke Traumatic Brain Injury Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Non-Stroke Subjects

Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols

Group Type EXPERIMENTAL

Electroencephalogram

Intervention Type DIAGNOSTIC_TEST

A routine test that involves attaching small wires to the head to read the electrical activity of the brain

Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

Noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain. An electromagnetic coil is placed against the scalp near the forehead. The electromagnet painlessly delivers repetitive magnetic pulses to simulate nerve cells in the brain.

Transcranial Direct Current Stimulation

Intervention Type PROCEDURE

Noninvasive procedure that uses direct electrical currents to stimulate the brain. A constant, low intensity current is passed through two electrodes that are place on the head.

Stroke Subjects

Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols

Group Type EXPERIMENTAL

Electroencephalogram

Intervention Type DIAGNOSTIC_TEST

A routine test that involves attaching small wires to the head to read the electrical activity of the brain

Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

Noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain. An electromagnetic coil is placed against the scalp near the forehead. The electromagnet painlessly delivers repetitive magnetic pulses to simulate nerve cells in the brain.

Transcranial Direct Current Stimulation

Intervention Type PROCEDURE

Noninvasive procedure that uses direct electrical currents to stimulate the brain. A constant, low intensity current is passed through two electrodes that are place on the head.

Interventions

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Electroencephalogram

A routine test that involves attaching small wires to the head to read the electrical activity of the brain

Intervention Type DIAGNOSTIC_TEST

Transcranial Magnetic Stimulation

Noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain. An electromagnetic coil is placed against the scalp near the forehead. The electromagnet painlessly delivers repetitive magnetic pulses to simulate nerve cells in the brain.

Intervention Type PROCEDURE

Transcranial Direct Current Stimulation

Noninvasive procedure that uses direct electrical currents to stimulate the brain. A constant, low intensity current is passed through two electrodes that are place on the head.

Intervention Type PROCEDURE

Other Intervention Names

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EEG TMS tDCS

Eligibility Criteria

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Inclusion Criteria

\- Acquired brain injury such as ischemic or hemorrhagic stroke or traumatic brain injury.


\- No known active neurological disorder.

Exclusion Criteria

* Pregnancy
* Contraindication to MRI or TMS including metallic implanted objects.
* Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
* Severe aphasia.
* History of epilepsy.
* History of active depression or treatment resistant depression.
* History of schizophrenia.


* Pregnancy
* Contraindication to MRI or TMS including metallic implanted objects.
* History of acquired brain injury.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Zafer Keser

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zafer Keser, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

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Other Identifiers

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21-012185

Identifier Type: -

Identifier Source: org_study_id

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