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临床试验/NCT04019054
NCT04019054终止不适用

Transcranial Magnetic Stimulation (TMS) in Conjunction With Exposure Therapy for the Treatment of Spider Phobia

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
2
主要终点
Change in Subjective Distress, Syzmanski Fear of Spiders Questionnaire

研究概览

简要总结

Spider phobia is an exceedingly common phobia throughout the world. The current standard treatment involves exposure therapy, which consists of a series of brief exposures of an individual to the thing they fear, in this case spiders. This study aims to examine the use of a neuromodulatory technology, transcranial magnetic stimulation (TMS), as a possible treatment option for spider phobia. TMS uses low-intensity electromagnetic energy to stimulate the brain, introducing energy into critical hubs of brain networks to "reset" their function and alleviate symptoms with very few side-effects.

This study will consist of four separate visits. After screening subjects for spider phobia, baseline testing of subjective distress measures and physiologic stress data (heart rate variability and sweat response) during a prolonged spider exposure test will be collected. Subjects will then be placed into one of two groups: one receiving exposure therapy and intermittent Theta Burst Stimulation (iTBS) TMS (active study group), and another receiving exposure therapy with iTBS to a circuit not involved in a phobic reaction (control study group). Subjects will undergo their first treatment session during the first visit following the baseline data collection; the second and third treatments will occur the following two days. The fourth visit will occur one week after the third and consist of the same testing as the first visit; the same data will be collected. Changes from pre- to post-treatment in both subjective and physiologic data will be compared between the treatment and sham groups to examine effects of TMS on spider phobia.

详细描述

OVERVIEW The experiment will consist of four days. Day 1 will include informed consent, questionnaires, a behavioral approach test with a spider, a series of short exposures with a spider, and the first TMS treatment (for a total of approximately 75-90 minutes). Day 2 will occur one to two days after Day 1 and will consist of a second series of short exposures with a spider and the second TMS treatment (30 minutes). Day 3 will occur one to two days after Day 2 and will also consist of a series of short exposures and a TMS treatment (30 minutes). Day 4 will occur five to seven days after Day 3 and will consist of post-study questionnaires and an identical behavioral approach test as is conducted on the first visit (30 minutes). Participants will be randomized to either an active TMS treatment group (using an iTBS stimulation protocol over the participant's ventro-medial prefrontal cortex, an area involved in phobic response) or a control TMS treatment group (using the same iTBS stimulation protocol over the central sulcus and between hemispheres, a site not associated with memory or fear response).

Prospective participants will be recruited from two groups: 1) undergraduate students recruited through the UCLA Psychology Department Subject Pool (i.e., SONA) and 2) general population over the age of 18 recruited via flyers. All prospective participants will be screened with the 31-question Spider Phobia Questionnaire (SPQ) to ensure eligibility for participation, with a minimum total score equal to or greater than 17 required for participation.(Klorman, Weerts, Hastings, Melamed, & Lang, 1974) Participants will be enrolled for the study only if they are able to complete all four visits of the experiment. Exclusion criteria will include:

  1. Subject is mentally or legally incapacitated, unable to give informed consent.
  2. Subjects with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
  3. Subjects with a HamD suicidality item score of '3' or '4,' corresponding to "suicidal ideas or gestures" or "attempts at suicide," will be excluded.
  4. Subjects with exposure to ECT within the past 6 months, previous TMS treatment for any condition, or VNS treatment (lifetime).
  5. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
  6. Any history of intracranial implant including cochlear implant, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling.
  7. Neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or with primary or secondary tumors in the CNS.
  8. current pregnancy or breast feeding.
  9. Infection or loss of integrity of skin over the forehead, where the device will be positioned.
  10. Increased risk of seizure as indicated by: a) history (or family history) of seizure or epilepsy; b) history of stroke, head injury, or unexplained seizures; c) concurrent medication use such as tricyclic antidepressants, neuroleptic medications, or other drugs that are known to lower the seizure threshold; d) secondary conditions that may significantly alter electrolyte balance or lower seizure threshold; e) no quantifiable motor threshold such that TMS dosage cannot be accurately determined.
  11. Known bee, insect, or arachnid allergy
  12. Other medical contraindications to any of the study procedures.

Participants will be assigned course credit or receive financial compensation after participating in the study. Those who participate through SONA recruitment will receive course credit. Participants will sign up for the study only if they are able to make all four visits of the experiment. If a participant does not attend all three visits, course credit will still be given for the amount of time the participant spent doing the experiment (i.e., 1 credit for 1 hour).

After screening, participants will be emailed blank copies of the forms, questionnaires, and screening tools that will be completed during the first visit, and they will be informed that they may complete the forms in advance and bring the completed forms with them to save time, should they desire. They will be asked to not return their forms via email, and to only bring them to the first visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Assignment will be performed randomly and tracked by clinical staff involved with the TMS treatment itself, and research staff assessing outcomes and analyzing data will be blinded to groups until after analysis is complete.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age
  • English-speaking
  • Spider phobia as determined by a Spider Phobia Questionnaire (SPQ; Klorman et al 1974) score of at least 17/30

排除标准

  • Subject is mentally or legally incapacitated, unable to give informed consent.
  • Subjects with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
  • Subjects with a HamD suicidality item score of '3' or '4,' corresponding to "suicidal ideas or gestures" or "attempts at suicide," will be excluded.
  • Subjects with exposure to ECT within the past 6 months, previous TMS treatment for any condition, or VNS treatment (lifetime).
  • Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
  • Any history of intracranial implant including cochlear implant, implanted electrodes/stimulators, aneursym clips or coils, stents, bullet fragments; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling.
  • Neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or with primary or secondary tumors in the CNS.
  • current pregnancy or breast feeding. The effects of TMS on pregnant and breastfeeding patients has not been systematically studied.
  • Infection or loss of integrity of skin over the forehead, where the device will be positioned.
  • Increased risk of seizure as indicated by: a) history (or family history) of seizure or epilepsy; b) history of stroke, head injury, or unexplained seizures; c) concurrent medication use such as tricyclic antidepressants, neuroleptic medications, or other drugs that are known to lower the seizure threshold; d) secondary conditions that may significantly alter electrolyte balance or lower seizure threshold; e) no quantifiable motor threshold such that TMS dosage cannot be accurately determined.
  • Known bee, insect, or arachnid allergy
  • Other medical contraindications to any of the study procedures.

结局指标

主要结局

Change in Subjective Distress, Syzmanski Fear of Spiders Questionnaire

时间窗: baseline and 1 week

Changes in scores on questionnaires regarding distress around spiders (Syzmanski Fear of Spiders Questionnaire). 18 items each scored on a scale of 1-7 (total score ranging 18-126), with higher numbers associated with greater subjective fear of spiders. No subscales reported

Change in Subjective Distress, Klorman Spider Phobia Questionnaire

时间窗: baseline and 1 week

Changes in scores on questionnaires regarding distress around spiders (Klorman spider phobia questionnaire). Scored on a scale of 0-31, with higher numbers associated with greater subjective fear of spiders. No subscales reported

Behavioral Approach Test, Change in Steps Completed

时间窗: baseline and 1 week after treatment

The difference between the number of steps completed during the pre- and post-treatment behavioral approach tests.

次要结局

  • Behavioral Approach Test, Change in Skin Conductance(baseline and 1 week after treatment)
  • Change in Subjective Maximum Distress, Behavioral Approach Test(baseline and 1 week, change in scores from pre to post reported)
  • Average Treatment Intensity Tolerated(Average tolerated intensity during TMS treatment sessions (days 1, 2, and 3 of treatment))
  • Change in Subjective Anticipatory Distress, Behavioral Approach Test(baseline and 1 week, difference reported)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael K Leuchter

Medical Student, David Geffen School of Medicine

University of California, Los Angeles

研究点 (2)

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