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RECRUITING NA

Neurostimulation Versus Therapy for Problems With Emotions

NCT05712057 · View on ClinicalTrials.gov ↗

Study Summary

The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.

Interventions

  • DEVICE Repetitive Transcranial Magnetic Stimulation (rTMS)
  • BEHAVIORAL Cognitive Restructuring
  • DEVICE electrical scalp stimulation
  • BEHAVIORAL Emotional Awareness Training

Study Locations (1)

North Carolina

  • Duke University Medical Center — Durham

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2023-05-15
Est. Completion 2027-12-01
Phase NA

Sponsor

Duke University

1,129 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05712057

The ClinicalTrials.gov registry entry for NCT05712057 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Anxiety Disorders appearing as the primary indexed condition, and to 4 interventions — of which Repetitive Transcranial Magnetic Stimulation (rTMS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05712057 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05712057 about?

NCT05712057 is a clinical study titled "Neurostimulation Versus Therapy for Problems With Emotions". The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary a...

What is the current status of trial NCT05712057?

This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2023-05-15. Estimated completion is 2027-12-01.

What conditions does trial NCT05712057 study?

This clinical trial studies the following conditions: Anxiety Disorders, Mood Disorders, Eating Disorders, Emotion Regulation, OCD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05712057?

The interventions under investigation include: Repetitive Transcranial Magnetic Stimulation (rTMS) (DEVICE), Cognitive Restructuring (BEHAVIORAL), electrical scalp stimulation (DEVICE), Emotional Awareness Training (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05712057?

This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05712057 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial