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NCT06333925 · ClinicalTrials.gov registry record · NA
Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study
A NA study of Anxiety Disorder and Misophonia, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06333925: Recruiting NA study of Anxiety Disorder and Misophonia, sponsored by Duke University.
NCT06333925 is a NA study of Anxiety Disorder and Misophonia that is actively recruiting participants, run by Duke University. The registered enrollment target is 60 participants, below the 422-participant average among 20 other Anxiety Disorder trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06333925, a NA study of Anxiety Disorder and Misophonia, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress. Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits.
Primary Outcome
Blood Oxygenation Level Dependent (BOLD) imaging is a technique that is commonly used for estimating brain activity using functional magnetic resonance imaging (fMRI). Change in the fMRI BOLD signal notes changes in brain blood flow and blood oxygenation, which are associated with neuronal activity. For each participant,the difference in BOLD activation between follow up and intake was computed. The BOLD signal contrast between engaging with misophonic sounds and engaging with aversive sounds we
Conditions Studied
Interventions
- DEVICE High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS)
- DEVICE Sham Repetitive Transcranial Magnetic Stimulation (sham- rTMS)
- BEHAVIORAL Cognitive Restructuring
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-05-14 |
| Est. Completion | 2026-11-30 |
| Phase | NA |
What NCT06333925 shows while recruiting
NCT06333925 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 422-participant average among 20 other Anxiety Disorder trials with a reported enrollment target (86% lower).
The record links to 6 conditions, with Anxiety Disorder appearing as the primary indexed condition, and to 3 interventions - of which High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS) is the first listed.
NCT06333925 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06333925 about?
NCT06333925 is a clinical study titled "Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study". Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotio...
What is the current status of trial NCT06333925?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-05-14. Estimated completion is 2026-11-30.
What conditions does trial NCT06333925 study?
This clinical trial studies the following conditions: Anxiety Disorder, Misophonia, Sensory Processing Disorder, Emotion Dysregulation, Auditory Over Responsivity.
What interventions are being tested in trial NCT06333925?
The interventions under investigation include: High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS) (DEVICE), Sham Repetitive Transcranial Magnetic Stimulation (sham- rTMS) (DEVICE), Cognitive Restructuring (BEHAVIORAL).
Who is sponsoring clinical trial NCT06333925?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06333925 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06333925's enrollment target sits among peer trials
60 9th of 20 higher than 12 of 20 other Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorder 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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