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NCT04348591 · ClinicalTrials.gov registry record · NA
Identifying the Optimal Neural Target for Misophonia Interventions
A NA study of Misophonia and Emotion Dysregulation, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT04348591: Completed NA study of Misophonia and Emotion Dysregulation, sponsored by Duke University.
NCT04348591 is a NA study of Misophonia and Emotion Dysregulation that has completed, run by Duke University. The registered enrollment target is 59 participants, above the 50-participant average among 7 other Misophonia trials with a reported enrollment target (18% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04348591, a NA study of Misophonia and Emotion Dysregulation, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
Misophonia, the inability to tolerate certain repetitive aversive sounds that are common, is gaining recognition as a debilitating condition. It is not a well-understood condition and there are no known treatments. Up to one in five people report moderate or higher misophonia symptoms; nevertheless, resources aimed at understanding and treating this problem are scarce. In order to align misophonia research with the priorities of large funding agencies such as the National Institute of Mental Health, the investigators propose a novel study aimed at separating misophonic distress from other types of emotional distress. The investigators plan to examine changes in brain activation during presentation and regulation of misophonic versus distressing sounds. Emergent neural networks that may be involved in misophonia will then be tested in the lab with the use of noninvasive neurostimulation, a novel tool that can enhance or inhibit activation in a targeted brain region. The investigators plan to modulate activation in key areas of the misophonia brain circuitry with the aim to identify the optimal neural target for misophonia interventions. Our multidisciplinary team at the Duke Center for Misophonia and Emotion Regulation brings together experts in misophonia, neuroscience, neuromodulation, neurology, and biostatistics who share the long-term goal of developing and refining an intervention for this condition in an environment that is optimal to conduct the proposed research. The investigators propose to recruit adults who self-report significant misophonia symptoms and adults who meet criteria for a current psychiatric disorder and who self-report difficulties calming down when upset. All participants will undergo a brain imaging session during which misophonic cues; distressing, non-misophonic cues; or neutral cues will be presented. Participants will then be asked to experience, or attempt to downregulate emotions associated with these cues. Based on the imaging resu
Primary Outcome
HF-HRV was extracted from 2 minute blocks during which participants engage in a behavioral strategy (listen or downregulate emotions using cognitive restructuring), while listening to neutral, aversive, and misophonic sounds and receive active or sham neurostimulation. The results represent the average HF-HRV during experimental blocks. The raw values were transformed using a logarithmic function to preserve the normality assumption.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Restructuring
- DEVICE neurostimulation
Study Locations (1)
North Carolina
- Duke University Medical Center-Civitan Bldg - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2020-10-28 |
| Est. Completion | 2022-05-28 |
| Phase | NA |
What the finished NCT04348591 record still lists
NCT04348591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, above the 50-participant average among 7 other Misophonia trials with a reported enrollment target (18% higher).
The record links to 2 conditions, with Misophonia appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Restructuring is the first listed.
NCT04348591 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04348591 about?
NCT04348591 is a clinical study titled "Identifying the Optimal Neural Target for Misophonia Interventions". Misophonia, the inability to tolerate certain repetitive aversive sounds that are common, is gaining recognition as a debilitating condition. It is not a well-understood condition and there are no known treatments. Up to one in five people report moderate or higher misophonia symptoms; nevertheless,...
What is the current status of trial NCT04348591?
This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2020-10-28. Estimated completion is 2022-05-28.
What conditions does trial NCT04348591 study?
This clinical trial studies the following conditions: Misophonia, Emotion Dysregulation.
What interventions are being tested in trial NCT04348591?
The interventions under investigation include: Cognitive Restructuring (BEHAVIORAL), neurostimulation (DEVICE).
Who is sponsoring clinical trial NCT04348591?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04348591 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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