protocolSection identificationModule nctId: NCT06333925, orgStudyIdInfo id: Pro00114183, briefTitle: Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study, acronym: MISO-STIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: Misophonia Research Fund, descriptionModule briefSummary: 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., conditionsModule conditions: Misophonia, conditions: Emotion Dysregulation, conditions: Sensory Processing Disorder, conditions: Auditory Over Responsivity, conditions: Anxiety Disorder, conditions: Sound Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In regards to the neurostimulation used in the study, there will be two conditions, receiving either active or sham neurostimulation. Both conditions will receive behavioral training in cognitive restructuring (CR; a type of emotion regulation skill). Randomization procedures will match participants on age, gender at birth, and misophonia impairment severity., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: All participants will engage in a behavioral training session (Cognitive Restructuring).The study team member who will conduct the behavioral session will be kept blind to the type of neurostimulation the participant will receive. Participants will also be kept blinded to what neurostimulation they receive and their perception of what they received will be assessed at follow-up. The intervention provider will also be kept blind to the treatment condition to ensure non-biased administration of the intervention.Participants will only be told about the type of neurostimulation at the end of the study to protect against different expectations, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS), interventions name: Sham Repetitive Transcranial Magnetic Stimulation (sham- rTMS), interventions name: Cognitive Restructuring, outcomesModule primaryOutcomes measure: Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and exposure to misophonic versus aversive sounds, primaryOutcomes measure: Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and downregulation of versus exposure to misophonic sounds, primaryOutcomes measure: Differential change in BOLD signal within the Anterior Insular Cortex (AIC) activation when being presented with misophonic versus non-misophonic but aversive sounds, primaryOutcomes measure: Differential change in BOLD signal connectivity between the left Anterior Insular Cortex (AIC) and the right dorsolateral prefrontal cortex (dlPFC) when downregulating versus experiencing distress related to misophonic trigger sounds, primaryOutcomes measure: Change in misophonia impairment and severity using a composite, primaryOutcomes measure: Skin conductance level (scl), primaryOutcomes measure: Change in Subjective Unites of Distress (SUDS), secondaryOutcomes measure: Changes in self-reported psychopathology, secondaryOutcomes measure: Changes in clinician-assessed psychopathology, secondaryOutcomes measure: Emotional dysregulation as measured by the Difficulties in Emotion Regulation Scale (DERS), otherOutcomes measure: Changes in self-reported cognitive flexibility, otherOutcomes measure: Changes in self-reported cognitive skills, otherOutcomes measure: Baseline emotional dysregulation, otherOutcomes measure: Baseline hyperacusis, otherOutcomes measure: Baseline Affect Intensity, otherOutcomes measure: Change in Emotional distress, otherOutcomes measure: Change in self-reported Emotion regulation, otherOutcomes measure: Change in Sensory sensitivity, otherOutcomes measure: Change in Interoceptive Awareness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Duke University Medical Center, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Jessica Choi, MA, role: CONTACT, phone: 919-684-4432, email: jessica.choi@duke.edu, contacts name: Lisalynn D Kelley, BA, CCRP, role: CONTACT, phone: 919-684-6701, email: lisalynn.kelley@duke.edu, contacts name: Andrada D Neacsiu, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False