Status:
TERMINATED
TMS and Exposure Therapy
Lead Sponsor:
University of California, Los Angeles
Conditions:
Arachnophobia
Phobia
Eligibility:
All Genders
18+ years
Phase:
NA
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 thin...
Detailed Description
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 fir...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04019054
Start Date
August 19 2019
End Date
March 18 2020
Last Update
April 1 2021
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095