Acquired Brain InjuryNCT05472363
TMS-EEG for Cortical Excitability
A study testing Electroencephalogram, Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation in people with Acquired Brain Injury and Stroke, run by Mayo Clinic.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury, Stroke, Traumatic Brain Injury
- What is being tested?
- Electroencephalogram, Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acquired brain injury such as ischemic or hemorrhagic stroke or traumatic brain injury.
- No known active neurological disorder.
Who cannot join
- 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.
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- History of schizophrenia.
- Pregnancy
- Contraindication to MRI or TMS including metallic implanted objects.
- History of acquired brain injury.
About this study
Official title: Electroencephalogram Coupled Non-invasive Brain Stimulation For Assessment of Cortical Excitability
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).
- Conditions
- Acquired Brain Injury, Stroke, Traumatic Brain Injury, Healthy
- Being tested
- Electroencephalogram, Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation
- Medical subject headings
- Brain Injuries, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalogramDiagnostic test
Also called EEG
A routine test that involves attaching small wires to the head to read the electrical activity of the brain
Transcranial Magnetic StimulationProcedure or surgery
Also called TMS
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 StimulationProcedure or surgery
Also called tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-Stroke Subjects | Experimental | Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols Receives: Diagnostic Test: Electroencephalogram; Procedure: Transcranial Magnetic Stimulation; Procedure: Transcranial Direct Current Stimulation |
| Stroke Subjects | Experimental | Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols Receives: Diagnostic Test: Electroencephalogram; Procedure: Transcranial Magnetic Stimulation; Procedure: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ)
Measured using Western Aphasia Battery Bedside Version. Higher score is better. Ranged from 0-100.
Measured: Baseline, 3 months
Change in Modified Rankin Scale
Measured using the Modified Rankin Scale (MRS) to assess functional outcome measure in stroke that utilizes a structured interview to assign subjects MRS grades 0-5 in a systematic way, grade 5 is severe disability, grade 0 is no symptoms at all
Measured: Baseline, 3 months
Change in neurological outcome (NIHSS)
Measured using the National Institutes of Health Stroke Scale (NIHSS). 15-item test to assess stroke-related neurologic deficits, each item scored with 3-5 grades with 0 as normal.
Measured: Baseline, 3 months
EEG and TMS-EEG functional connectivity
EEG power in high and low frequency bands will be measured and power density maps will be created. TMS-evoked potentials and oscillations will be measured.
Measured: Baseline
MRI based structural connectivity.
Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Why it stopped: Challenges in TMS-EEG data protocol optimization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Keser, Mayo Clinic
- Investigators
- Zafer Keser, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472363
- Sponsor's protocol ID
- 21-012185
- Status last verified
- May 2024
- First submitted
- 7 Jul 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalogram Coupled Non-invasive Brain Stimulation For Assessment of Cortical Excitability
- ClinicalTrials.gov ID
- NCT05472363
- Acronym / sponsor ID
- 21-012185
- Conditions
- Acquired Brain Injury, Stroke, Traumatic Brain Injury, Healthy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Challenges in TMS-EEG data protocol optimization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Stroke Subjects | Experimental | Diagnostic Test: Electroencephalogram, Procedure: Transcranial Magnetic Stimulation, Procedure: Transcranial Direct Current StimulationSubjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols |
| Stroke Subjects | Experimental | Diagnostic Test: Electroencephalogram, Procedure: Transcranial Magnetic Stimulation, Procedure: Transcranial Direct Current StimulationSubjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acquired brain injury such as ischemic or hemorrhagic stroke or traumatic brain injury.
- No known active neurological disorder.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroencephalogramAlso: EEGA routine test that involves attaching small wires to the head to read the electrical activity of the brain | Diagnostic test | Non-Stroke Subjects, Stroke Subjects |
| Transcranial Magnetic StimulationAlso: TMSNoninvasive 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. | Procedure or surgery | Non-Stroke Subjects, Stroke Subjects |
| Transcranial Direct Current StimulationAlso: tDCSNoninvasive 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. | Procedure or surgery | Non-Stroke Subjects, Stroke Subjects |
Primary outcome
Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ)
Time frame: Baseline, 3 months
Measured using Western Aphasia Battery Bedside Version. Higher score is better. Ranged from 0-100.
Change in Modified Rankin Scale
Time frame: Baseline, 3 months
Measured using the Modified Rankin Scale (MRS) to assess functional outcome measure in stroke that utilizes a structured interview to assign subjects MRS grades 0-5 in a systematic way, grade 5 is severe disability, grade 0 is no symptoms at all
Change in neurological outcome (NIHSS)
Time frame: Baseline, 3 months
Measured using the National Institutes of Health Stroke Scale (NIHSS). 15-item test to assess stroke-related neurologic deficits, each item scored with 3-5 grades with 0 as normal.
EEG and TMS-EEG functional connectivity
Time frame: Baseline
EEG power in high and low frequency bands will be measured and power density maps will be created. TMS-evoked potentials and oscillations will be measured.
MRI based structural connectivity.
Time frame: Baseline
Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zafer Keser, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram, Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation in people with Acquired Brain Injury and Stroke, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ) (time frame: Baseline, 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.