EligibleTrials

Neurostimulation Versus Therapy for Problems With Emotions

Recruiting · NCT05712057 · Interventional (participants receive a specific treatment) · Lead sponsor: Duke University

View the official record on ClinicalTrials.gov →
Anxiety

Interventions studied

Cognitive RestructuringEmotional Awareness TrainingRepetitive Transcranial Magnetic Stimulation (rTMS)electrical scalp stimulation

What this trial is about

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.

Who can take part

Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

1 location listed across 1 US state.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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