Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333925
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-02-12
Brief Title:
Using Neurostimulation to Accelerate Change in Misophonia a Pilot Study
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Using Neurostimulation to Accelerate Change in Misophonia a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MISO-STIM
Brief 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 visits the initial MRI the four neurostimulation sessions the follow-up MRI and two additional remote 1- and 3-month follow-up visits
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 visits the initial MRI the four neurostimulation sessions the follow-up MRI and two additional remote 1- and 3-month follow-up visits
Detailed Description:
Given the urgent need for interventions for misophonia the primary purpose of this study is to establish short and long-term effects for an intervention that combines emotion regulation with neurostimulation The secondary goal is to examine the best parameters needed for a successful intervention It is important to highlight that the study findings would not only inform future behavioral and neurostimulation interventions but may also provide critical information for other intervention approaches that aim to alter neural circuitry involved in misophonia
Interested participants who pass the online and phone screen are scheduled for the first study visit that will be conducted remotely Those who are interested and provide e-consent will complete demographic questions and several interviews and measures aimed to examine misophonic and psychiatric distress verbal IQ treatment history and MRIneurostimulation safety Participants will listen to a set of standardized aversive and misophonic sounds and rate how distressing they find them They will also be invited to send recordings of their own misophonic sounds in different contexts and together with them and other standardized misophonic sounds they will listen to the sounds and rate their distress The goal in the study is to generate a personalized set of triggers that includes personalized misophonic aversive and neutral sounds for each participant
The type of neuromodulation that is being tested in the study is repetitive transcranial magnetic stimulation rTMS a procedure which involves placement of an electromagnetic coil over the scalp that produces very small electric currents in the part of the brain that is closest to the coil rTMS is a noninvasive procedure that is currently approved by the Food and Drug Administration FDA for the treatment for depression obsessive compulsive disorder and smoking In this study rTMS will be used differently than what has been approved for by the FDA but within safety guidelines
The goal of the study is to enroll sixty eligible adult participants with misophonia who will then be asked to come to Duke for the initial brain MRI visit Following established procedures participants will be briefly taught CR cognitive restructuring an emotion regulation strategy selected because it successfully adjusts the emotion regulation network Participants will undergo a functional neuroimaging MRI task based on which a personalized neurostimulation target will be established
Participants will then be randomly assigned to active or sham rTMS intervention matching on age gender at birth and misophonia impairment severity Participants will then undergo four consecutive intervention sessions during which they will receive either type of rTMS over their personalized target on the right side of the brain while being exposed to personalized misophonic cues and instructed to engage in cognitive emotion regulation At the initial TMS visit all participants will be trained in CR in depth using a standardized training session During each neurostimulation session biophysiological data including heart rate and skin conductance will be collected
A week after the intervention participants will undergo a follow up MRI brain scan and will complete some of the questionnaires from the first visit regarding misophonia mood anxiety difficulties managing emotions general health and distress
Two additional remote follow-up visits will be scheduled at the 1- and 3-month follow-up time points Participants will complete the remote sound task similar to the first remote study visit Measures of misophonia mood anxiety difficulties managing emotions general health and distress will again be assessed At the final 3-month follow-up visit participants will also complete an exit interview to give feedback on their study participation As part of the exit interview a member of the study team will inform the participant what type of neurostimulation they received during the study and referrals will be provided if applicable
Interested participants who pass the online and phone screen are scheduled for the first study visit that will be conducted remotely Those who are interested and provide e-consent will complete demographic questions and several interviews and measures aimed to examine misophonic and psychiatric distress verbal IQ treatment history and MRIneurostimulation safety Participants will listen to a set of standardized aversive and misophonic sounds and rate how distressing they find them They will also be invited to send recordings of their own misophonic sounds in different contexts and together with them and other standardized misophonic sounds they will listen to the sounds and rate their distress The goal in the study is to generate a personalized set of triggers that includes personalized misophonic aversive and neutral sounds for each participant
The type of neuromodulation that is being tested in the study is repetitive transcranial magnetic stimulation rTMS a procedure which involves placement of an electromagnetic coil over the scalp that produces very small electric currents in the part of the brain that is closest to the coil rTMS is a noninvasive procedure that is currently approved by the Food and Drug Administration FDA for the treatment for depression obsessive compulsive disorder and smoking In this study rTMS will be used differently than what has been approved for by the FDA but within safety guidelines
The goal of the study is to enroll sixty eligible adult participants with misophonia who will then be asked to come to Duke for the initial brain MRI visit Following established procedures participants will be briefly taught CR cognitive restructuring an emotion regulation strategy selected because it successfully adjusts the emotion regulation network Participants will undergo a functional neuroimaging MRI task based on which a personalized neurostimulation target will be established
Participants will then be randomly assigned to active or sham rTMS intervention matching on age gender at birth and misophonia impairment severity Participants will then undergo four consecutive intervention sessions during which they will receive either type of rTMS over their personalized target on the right side of the brain while being exposed to personalized misophonic cues and instructed to engage in cognitive emotion regulation At the initial TMS visit all participants will be trained in CR in depth using a standardized training session During each neurostimulation session biophysiological data including heart rate and skin conductance will be collected
A week after the intervention participants will undergo a follow up MRI brain scan and will complete some of the questionnaires from the first visit regarding misophonia mood anxiety difficulties managing emotions general health and distress
Two additional remote follow-up visits will be scheduled at the 1- and 3-month follow-up time points Participants will complete the remote sound task similar to the first remote study visit Measures of misophonia mood anxiety difficulties managing emotions general health and distress will again be assessed At the final 3-month follow-up visit participants will also complete an exit interview to give feedback on their study participation As part of the exit interview a member of the study team will inform the participant what type of neurostimulation they received during the study and referrals will be provided if applicable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None