Phase
Condition
Panic Disorders
Anxiety Disorders
Pseudobulbar Affect
Treatment
Repetitive Transcranial Magnetic Stimulation (rTMS)
electrical scalp stimulation
Cognitive Restructuring
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
age 18 to 55
elevated overall score on Difficulties with Emotion Regulation Scale (DERS totalscore >=90)
has been in the same type of psychotherapy (including none) for the last 4 weeks/1mo (*except for current CBT) and is willing to stay on the same regimen throughout thestudy.
low self-reported use of cognitive restructuring (ERQ restructuring subscale averagescore < 4.7)
meets criteria for at least one mood (including Bipolar II w/o current hypomania),anxiety, stressor, OCD, Impulse Control, ADHD, or eating DSM-5 disorder (exceptexclusionary diagnoses such as severe anorexia). Note: Both current or partialremission of the disorder will be ok for inclusion into the study.
verbal agreement to maintain dose of prescribed psychotropic medication (if any)constant throughout the study, provided they are stable on it for the past 4 weeks (except exclusion medication and except if there is a medical emergency requiringchanges in medication).
Naïve to rTMS
Exclusion
Exclusion Criteria:
current hypomania (Note: Bipolar II w/o current hypomanic episode is ok forinclusion)
meets diagnostic criteria for current or history of psychotic disorder, or psychoticfeatures,
meets diagnostic criteria for Bipolar I disorder
meets diagnostic criteria on SCID5 for current alcohol or substance use disorder (moderate and high severity) or meets past history of severe alcohol use disorder
unable to read, blind, or deaf, or unwilling to give consent
non-English speaker,
verbal IQ < 90 on the North American Adult Reading Test (NART).
current uncontrolled anorexia or other condition requiring hospitalization
high risk for suicide defined as either having attempted suicide in past 6 months orreporting current suicidal ideation that includes a method, plan, or intent to die
current serious medical illness, including current severe migraine headaches
started/changed psychotropic medications in the prior 4 weeks, or plans to changemedication during the study
history of seizure except those therapeutically induced by ECT (childhood febrileseizures are acceptable and these subjects may be included in the study), history ofepilepsy in self or first degree relatives, stroke, brain surgery, head injury,cranial metal implants, known structural brain lesions that are contraindicationsfor TMS, devices that may be affected by TMS (pacemaker, medication pump, cochlearimplant, implanted brain stimulator), have left elbow/hand/wrist tendonitis
conditions associated with increased intracranial pressure, space occupying brainlesion (considered significant and unsafe for TMS by the study MD), transientischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease,multiple sclerosis
Wellbutrin >300mg per day or on daily stimulant/ADHD medications above therecommended FDA daily recommendations
use of investigational drug or devices within 4 weeks of screening
cochlear implants
Pregnancy
metal in body that would exclude them from the MRI scan; severe claustrophobia
is a prisoner or in police custody at time of screening, or has pending court casejeopardizing the participation in the study
has had TMS in their lifetime
has had CBT in the past 4 weeks or plans to start therapy during the study
weighs over 300 pounds (could not fit in MRI scanner)
Study Design
Study Description
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting

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