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HealthyPhase 4NCT05962385

State Dependence of Prefrontal Transcranial Magnetic Stimulation

A Phase 4 study testing Brain state while receiving TMS in people with Healthy, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Brain state while receiving TMS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
24 Aug 2023to 17 Nov 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 - 65,
  • healthy controls

Who cannot join

  • Diagnosed psychiatric disorder
  • Potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
  • Potential contraindication to TMS (as identified by the TMS safety screener)
  • Any previous adverse reaction to TMS or MRI
  • Diagnosed epilepsy or previously experienced a seizure
  • Diagnosed neurological condition, such as stroke or tinnitus
Show all 11Show fewer
  • Experienced a head trauma that was diagnosed as concussion
  • Current use of, or recent withdrawal from, medications that can increase the risk of seizure
  • Currently pregnant
  • Any metal in the head (excluding mouth)
  • Any implanted medical device

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

The study will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while receiving transcranial magnetic stimulation. The study will measure change in brain function with EEG.

Conditions
Healthy
Being tested
Brain state while receiving TMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain state while receiving TMSDevice

    Transcranial magnetic stimulation was delivered while participants engaged in either a cognitive control task or a perceptual discrimination task. Each participant completed both active-state and control-state TMS conditions across separate sessions.

Study groups in NCT05962385
Study groupRoleWhat they receive
Healthy control (Within-subject TMS Study)ExperimentalParticipants completed both active-state transcranial magnetic stimulation (TMS) and control-state TMS conditions in a repeated-measures, within-subject design. TMS was delivered during high prefrontal cortex (PFC)-demand cognitive control states and during low PFC-demand perceptual discrimination states.
Receives: Device: Brain state while receiving TMS
No TMS Follow-up StudyNo interventionParticipants completed the behavioral paradigm without TMS in a separate follow-up sample under the same IRB protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Theta Power Task-Evoked Change Score

    Pre- to post-TMS change in theta-band oscillatory power was measured by electroencephalography during performance of a cognitive control task. The cognitive control task was administered immediately before and after TMS. Task-evoked theta responses were averaged across trials at each time point, and a within-subject change score was computed as post-intervention theta power minus pre-intervention theta power for each condition. Values are reported in decibels (dB), with higher values indicating greater post-intervention theta power relative to baseline.

    Measured: Immediately before and after TMS during the experimental session; 0 to 500 milliseconds after each TMS stimulus

  2. Cortical Theta Generator Excitability

    Theta-band spectral power evoked by TMS was measured using TMS-EEG event-related spectral perturbations in the 0 to 500 millisecond window following single-pulse TMS and within the theta oscillatory band of 4 to 8 Hz. For each participant, TMS-evoked theta responses were averaged across trials for each condition: Active-state TMS and Control-state TMS. Responses are measured in decibels (dB) relative to baseline, with higher values indicating greater cortical theta generator excitability.

    Measured: Immediately following TMS stimulation; 0 to 500 milliseconds after each TMS stimulus

Secondary outcomes (4)

  1. Cognitive Control Enhancement (Accuracy)

    Pre/Post ratios of response accuracy in a cognitive control task. Accuracy was computed for each run of the cognitive control task, as the proportion of correct behavioural responses relative to the number of task trials (120). Scores \> 1 indicate an improvement in cognitive control performance relative to baseline; scores \< 1 indicate a reduction in cognitive control performance relative to baseline.

    This is done Immediately before (Pre) and within 5 minutes after (Post) TMS in the Active-state and Control-state TMS conditions. In the No TMS Arm, outcome was assessed in the first and last administrations of the cognitive control task. Each cognitive control assessment lasted up to 20 minutes each.

    Measured: Immediately before and within 5 minutes after TMS in the Active-state and Control-state TMS conditions; in the No TMS arm, assessed during the first and last administrations of the cognitive control task.

  2. Cognitive Control Enhancement (Reaction Time)

    Pre/Post difference of reaction time in a cognitive control task.

    Measured: Immediately before and within 5 minutes after TMS in the Active-state and Control-state TMS conditions; in the No TMS arm, assessed during the first and last administrations of the cognitive control task.

  3. Cognitive Control Enhancement (D'-Context)

    Pre/Post ratios of D'-Context during the cognitive control task. D'-Context was computed separately for each run as a signal-detection measure of sensitivity to contextual information, calculated from the standardized hit rate for AX trials and false-alarm rate for BX trials [D'-Context = z(AX hit rate) - z(BX false-alarm rate)]. Higher D'- Context values indicate greater sensitivity to task context and better cognitive control performance. Pre/Post ratios were calculated relative to baseline performance; scores \> 1 indicate an improvement in D'-Context relative to baseline, whereas scores \< 1 indicate a reduction in D'-Context relative to baseline.

    Measured: Immediately before and within 5 minutes after TMS in the Active-state and Control-state TMS conditions; in the No TMS arm, assessed during the first and last administrations of the cognitive control task.

  4. Cognitive Control Enhancement (Evidence Accumulation Bias)

    Pre/Post ratios of drift diffusion model (DDM) response bias during the cognitive control task. Response bias was quantified using the DDM starting-point parameter (z), which reflects the relative position of the decision process between the two response boundaries before evidence accumulation begins. Values shifted toward one boundary indicate a greater pre-decision bias toward the corresponding response, whereas values closer to the midpoint indicate less response bias. Pre/Post ratios were calculated relative to baseline; scores \> 1 indicate an increase in response bias relative to baseline, whereas scores \< 1 indicate a reduction in response bias relative to baseline.

    Measured: Immediately before and within 5 minutes after TMS in the Active-state and Control-state TMS conditions; in the No TMS arm, assessed during the first and last administrations of the cognitive control task.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start24 Aug 2023
  3. Primary completion31 Jul 2025
  4. Study completion17 Nov 2025

Resources

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 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Repeated measures design - across two separate sessions (one week apart, counterbalanced between participants), participants will receive transcranial magnetic stimulation (TMS) whilst engaging in either a cognitive control or a perceptual task.
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05962385
Sponsor's protocol ID
PSYCH-2023-32060
Status last verified
Sep 2026
First submitted
12 Jul 2023
Last updated
8 Oct 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brain state while receiving TMS in people with Healthy, run by University of Minnesota at 1 site in United States.

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 11 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: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Theta Power Task-Evoked Change Score (time frame: Immediately before and after TMS during the experimental session; 0 to 500 milliseconds after each TMS stimulus). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05962385.

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 8 Oct 2026.

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