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临床试验/NCT05928689
NCT05928689
已完成
早期 1 期

Misophonia-Related Memory Modification Using Reconsolidation Mechanisms: Pharmacological and Behavioral Manipulation

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 141 人2023年6月2日

概览

阶段
早期 1 期
干预措施
Propranolol Hydrochloride tablet
疾病 / 适应症
Misophonia
发起方
Icahn School of Medicine at Mount Sinai
入组人数
141
试验地点
1
主要终点
Change in average Galvanic skin response based on deflections of a wave
状态
已完成
最后更新
去年

概览

简要总结

One of the core processes presumably underlying misophonia - a condition characterized by decreased tolerance for specific sounds - is associative learning. Using behavioral, computational, and neural analyses of emotional learning and memory processes to understand the unknown behavioral and neural mechanisms underlying misophonia's associative learning and memory, the study team will evaluate whether interference with the reconsolidation of a reactivated misophonia memory with propranolol can alleviate aversive reaction to misophonia-related cues.

注册库
clinicaltrials.gov
开始日期
2023年6月2日
结束日期
2024年9月30日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Daniela Schiller

Professor of Neuroscience and Psychiatry

Icahn School of Medicine at Mount Sinai

入排标准

入选标准

  • Hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear.
  • Must be between the ages of 18 -
  • Must be fluent in English since the study's instructions, surveys, and tasks will be in English

排除标准

  • Disability or medical condition that prohibits completion of study. Participants must be able to complete all study procedures to ensure optimal conditions for data analysis.
  • CNS disease, such as history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, history of head trauma (defined as loss of consciousness\>3 min), or history of seizures without a resolved etiology. CNS disease and drugs that act in the peripheral or central nervous system are likely to have effects on patterns of neural activity. We wish to minimize confounding variables.
  • Recently used drugs of abuse.
  • Pregnancy. The risks associated with neither propranolol exposure during gestation have been studied extensively. We wish to safeguard the health of potential participants and their children.
  • Lactation. Propranolol is excreted in human breast-milk, and its impact on infant development has not been studied. We wish to safeguard the health of potential participants and their children.
  • Regular use of medication metabolized in the CYP2D6, 1A2, or 2C19 pathways. Drugs that are metabolized in the same pathway as propranolol may increase its efficacy or toxicity. We wish to safeguard the health of participants.
  • Blood pressure over 150/100 or under 100/60 (applicable for either systolic or diastolic measures) and any hypertension requiring medication. Propranolol is known to pose additional risk to individuals with a number of medical conditions. We wish to safeguard the health of our participants.
  • Pulse over 100 or under
  • History of cardiovascular illness such as cardiac arrhythmia, coronary heart disease or any cardiac dysfunction that requires medication.
  • Active respiratory illness including bronchospastic pulmonary disease and chronic obstructive pulmonary disease

研究组 & 干预措施

Memory Reminder followed by Propranolol Hydrochloride

This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a propranolol hydrochloride tablet.

干预措施: Propranolol Hydrochloride tablet

Memory Reminder followed by Propranolol Hydrochloride

This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a propranolol hydrochloride tablet.

干预措施: Reminder

Memory reminder followed by Placebo

This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a placebo tablet.

干预措施: Reminder

Memory reminder followed by Placebo

This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a placebo tablet.

干预措施: Placebo

No memory reminder followed by Propranolol Hydrochloride

This arm aims to have 30 participants with a pharmacological manipulation. They will not receive a reminder to reactivate their memory of a misophonia sound and only receive a propranolol hydrochloride tablet.

干预措施: Propranolol Hydrochloride tablet

Memory reminder followed by counterconditioning

This arm aims to have 30 participants with a behavioral manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger and then will undergo counterconditioning.

干预措施: Reminder

Memory reminder followed by counterconditioning

This arm aims to have 30 participants with a behavioral manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger and then will undergo counterconditioning.

干预措施: Counterconditioning

No memory reminder followed by counterconditioning

This arm aims to have 30 participants with a behavioral manipulation. They will not receive a reminder to reactivate their memory of a misophonia trigger and then undergo counterconditioning.

干预措施: Counterconditioning

结局指标

主要结局

Change in average Galvanic skin response based on deflections of a wave

时间窗: Baseline and after 6 hours

Using galvanic skin response based on deflections of a wave, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. A greater deflection indicates greater sympathetic nervous system arousal.

Change in average heart rate

时间窗: Baseline and after 6 hours

Using heart rate measurement, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. Reduced heart rate will indicate manipulation efficacy

Change in Approach-Avoidance test

时间窗: Baseline and after 6 hours

Using an approach-avoidance test, the difference between the monetary amounts earned before and after the pharmacological or behavioral manipulation will be measured. The minimum monetary amount earned is $0 and the maximum monetary amount earned is $23. A higher monetary amount earned indicates greater approach towards an avoidant cue. The difference in monetary amounts across conditions will be compared.

次要结局

  • Change in Approach-Avoidance test(Baseline and 1 month later)
  • Change in decision making task(Baseline and 1 month later)
  • Change in Average Galvanic skin response based on deflections of a wave(about 1 month later)
  • Change in average heart rate(about 1 month later)

研究点 (1)

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