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NCT05712057 · ClinicalTrials.gov registry record · NA
Neurostimulation Versus Therapy for Problems With Emotions
A NA study of Anxiety Disorders and Mood Disorders, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT05712057: Recruiting NA study of Anxiety Disorders and Mood Disorders, sponsored by Duke University.
NCT05712057 is a NA study of Anxiety Disorders and Mood Disorders that is actively recruiting participants, run by Duke University. The registered enrollment target is 240 participants, below the 1,137-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05712057, a NA study of Anxiety Disorders and Mood Disorders, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Calculation of physiological data High frequency HRV (HF-HRV) during regulation blocks during the neurostimulation day accounting for baseline controlling for baseline HF-HRV
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2027-12-01 |
| Phase | NA |
What NCT05712057 shows while recruiting
NCT05712057 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,137-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (79% lower).
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.
NCT05712057 reports a single indexed study location in North Carolina.
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.
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).
Who is sponsoring clinical trial NCT05712057?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Anxiety Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05712057's enrollment target sits among peer trials
240 21st of 84 higher than 64 of 84 other Anxiety Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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