N/A
Completed N=59
Identifying the Optimal Neural Target for Misophonia Interventions
Misophonia · Emotion Dysregulation
Source: ClinicalTrials.gov NCT04348591 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks — 1.8903; 1.9422; 1.9420; 1.9465 lg(ms^2) — p=.221
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 results, two personalized neurostimulation targets will be identified: (1) the region in the frontal cortex with the most activity during the downregulation of misophonic versus neutral sounds and (2) the prefrontal region with the strongest functional connectivity to the anterior insular cortex. Participants will receive real or sham neurostimulation over the prefrontal cortex and insula in a random order, while engaging in listening to versus downregulating misophonic, aversive, or neutral cues. The investigators plan to assess emotional dysregulation, psychopathology, and misophonia with a multi-method battery of measures during all three study appointments. Feasibility and acceptability will be examined qualitatively. If successful, our study can be the first step in a series of investigations that establish the unique targets for neural intervention for misophonia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks |
1.8903; 1.9422; 1.9420; 1.9465; 1.8923; 1.9771 | .221 |
| PRIMARY Skin Conductance Level (SCL) |
8.42392; 8.90082; 8.51538; 9.30579; 8.39378; 8.83644 | .34 |
| PRIMARY Behavioral Outcome: Acceptability of Procedures |
27; 27 | — |
| PRIMARY Neuroimaging Outcome: Differential Change in BOLD Signal Between Groups Within the Dorsolateral Prefrontal Cortex (dlPFC), That is Greater During Regulation of Misophonic Versus Non-misophonic Distress |
.4572; .4288 | .57 |
| PRIMARY Neuroimaging Outcome: Differential Change in BOLD Signal Within the Ventromedial Prefrontal Cortex (vmPFC) When Engaging in the Regulation of Emotional Versus Misophonic Distress |
.4967; .5233 | .778 |
| PRIMARY Neuroimaging Outcome: Differential Change in BOLD Signal Within the Anterior Insular Cortex (AIC) Activation When Being Presented With Cues for Emotional Versus Misophonic Distress |
.3744; .3093 | <.05 sig |
| SECONDARY Change in Subjective Units of Distress (SUDS) |
0.2981; 0.5370; -0.5769; -0.3611; -0.2130; 0.3056 | .49 |
| SECONDARY Emotional Dysregulation as Measured by the Difficulties in Emotion Regulation Scale (DERS) |
93.04; 112.43; 88.70; 99.85 | <.001 sig |
| SECONDARY Self-reported Health Status as Measured by the Patient Reported Outcome Measurement Information System (PROMIS)-43 Adult Profile |
14.10; 13.70; 11.28; 13.03; 14.97; 15.80 | .78 |
| SECONDARY Number of Clusters Across the Whole Brain With Significant BOLD Changes Between Groups When Contrasting the Exposure to Aversive Versus Neutral Sounds. |
0; 0 | — |
| SECONDARY Number of Clusters Across the Whole Brain With Significant BOLD Changes Between Groups When Contrasting the Exposure to Misophonic Versus Aversive Sounds. |
6; 3 | — |
| SECONDARY Number of Clusters Across the Whole Brain With Significant BOLD Changes Between Groups When Contrasting the Downregulation of Distress Associated With Misophonic Sounds to Exposure to Misophonic Sounds |
1; 0 | — |
| SECONDARY Number of Clusters Across the Whole Brain With Significant BOLD Changes Between Groups When Contrasting the Downregulation of Distress Associated With Aversive Sounds to Exposure to AversiveSounds |
0; 0 | — |
Eligibility Criteria
Interested participants will be excluded if:
- current or past history of mania or psychosis,
- verbal IQ < 70,
- not medically cleared for TMS or fMRI (for example taking medications known to reduce the seizure threshold such as Lamictal, Lithium, Clozaril, stimulants including the ADHD medications (e.g. Ritalin, Adderall), Wellbutrin/Buproprion, Provigil (Modafinil), Aminophylline, and Theophylline, implants, TBI, stroke, etc),
- going to jail in the next 2 months,
- pregnant,
- high risk for suicide
- moderate/severe current alcohol or substance dependence,
- cannot come to Duke for the three study visits.
Inclusion criteria are:
- stable psychotherapy and medication for at least 4 weeks
- self reports high emotional dysregulation OR misophonia
Participants will be matched on gender and age between the two groups
Data sourced from ClinicalTrials.gov (NCT04348591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.