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TMS and Exposure Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04019054
Recruitment Status : Terminated (COVID)
First Posted : July 15, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Michael K Leuchter, University of California, Los Angeles

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Arachnophobia Phobia Device: Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC) Device: Intermittent Theta Burst Stimulation (iTBS), vertex Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to either the study treatment (iTBS stimulation to the ventromedial prefrontal cortex) or control treatment (iTBS stimulation to the vertex). Treatments will occur immediately following exposure therapy (both groups will undergo identical exposure therapy), and groups will receive iTBS to the same site for all three treatments
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation (TMS) in Conjunction With Exposure Therapy for the Treatment of Spider Phobia
Actual Study Start Date : August 19, 2019
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : March 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias

Arm Intervention/treatment
Experimental: Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)

Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.

Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.

Device: Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC)
iTBS delivered to vmPFC for active treatment of spider phobia.

Placebo Comparator: Control iTBS, vertex

Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.

Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.

Device: Intermittent Theta Burst Stimulation (iTBS), vertex
iTBS delivered to vertex for placebo treatment of spider phobia.




Primary Outcome Measures :
  1. Behavioral Approach Test, change in steps completed [ Time Frame: baseline and 1 week ]
    The difference between the number of steps completed during the pre- and post-treatment behavioral approach tests.

  2. Behavioral Approach Test, change in skin conductance peaks [ Time Frame: baseline and 1 week ]
    The difference between the number of skin conductance peaks measured during the pre- and post-treatment behavioral approach tests.

  3. Change in Subjective Distress, Klorman Spider Phobia Questionnaire [ Time Frame: 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

  4. Change in Subjective Distress, Syzmanski Fear of Spiders Questionnaire [ Time Frame: 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


Secondary Outcome Measures :
  1. Change in Heart Rate Variability [ Time Frame: baseline and 1 week ]
    Change in heart rate variability at each step of BAT

  2. Behavioral Approach Test, change in skin conductance [ Time Frame: baseline and 1 week ]
    The difference between the change in skin conductance measured during the pre- and post-treatment behavioral approach tests.

  3. Change in Subjective Distress, behavioral approach test [ Time Frame: baseline and 1 week ]
    Changes in subjective distress (reported 0-100) reported at each step during the behavioral approach test


Other Outcome Measures:
  1. Number of exposure sessions attended [ Time Frame: baseline, 1 day, 2 days, 3 days ]
    The number of exposure therapy sessions attended by each participant

  2. Number of TMS sessions attended [ Time Frame: baseline, 1 day, 2 days, 3 days ]
    The number of TMS sessions attended by each participant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  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, 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.
  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. The effects of TMS on pregnant and breastfeeding patients has not been systematically studied.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019054


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Michael K Leuchter, B.S. University of California, Los Angeles
Principal Investigator: Marco Iacoboni, M.D., Ph.D. Professor, UCLA Psychiatry and Biobehavioral Science
Publications:
Appelhans, B. M., & Luecken, L. J. (2006). Heart rate variability as an index of regulated emotional responding. Review of General Psychology, 10(3), 229-240. http://doi.org/10.1037/1089-2680.10.3.229
Christopoulos, G. I., Uy, M. A., & Yap, W. J. (2016). The Body and the Brain: Measuring Skin Conductance Responses to Understand the Emotional Experience. Organizational Research Methods, 1-27. http://doi.org/10.1177/1094428116681073
Klorman, R., Weerts, T. C., Hastings, J. E., Melamed, B. G., & Lang, P. J. (1974). Psychometric description of some specific-fear questionnaires. Behavior Therapy, 5(3), 401-409. http://doi.org/10.1016/S0005-7894(74)80008-0

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Responsible Party: Michael K Leuchter, Medical Student, David Geffen School of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04019054    
Other Study ID Numbers: 19-000218
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael K Leuchter, University of California, Los Angeles:
Transcranial Magnetic Stimulation (TMS)
Exposure Therapy
Phobia
Intermittent Theta-Burst Stimulation (iTBS)
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders