Transcranial Treatments in Eating Disorders

Not Applicable

Terminated

• Conditions: Anorexia Nervosa; Bulimia Nervosa
• Interventions: Procedure: Transcranial direct current stimulation; Procedure: Transcranial magnetic stimulation

• Registration Number: NCT02535780
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The primary aim of this study is to study how Repetitive Transcranial Magnetic Stimulation (rTMS) tailored to specific anorexia nervosa (AN) or bulimia nervosa (BN) brain activation alterations will promote recovery and to study how inhibitory tDCS (Transcranial Direct Current Stimulation) will reduce symptoms of body image distortion in a second sample of AN and BN groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-08-31
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Anorexia Nervosa subjects:
• Meets DSM-5 criteria for anorexia nervosa (AN) either binge-eating/purging type or restricting-type:
• Intense fear of gaining weight or becoming fat, even though underweight.
• The ability to undergo an MRI, fMRI or other similar procedure requiring spending time in an enclosed space
• Bulimia Nervosa subjects:
• Meet DSM-5 criteria for bulimia nervosa (BN):
• Self-induced vomiting; misuse of laxatives, diuretics, enemas, medication, fasting, excessive exercise.

Exclusion Criteria

• Electrolyte, blood count or kidney or liver function abnormalities.
• No symptoms of alcohol or other substance abuse or dependence in the past 3 months,
• No previous or current organic brain syndromes, dementia, psychotic disorders, somatization disorders, or conversion disorder, head trauma, indication of mental retardation or pervasive developmental disorder.
• No antipsychotics, tricyclic antidepressants or Wellbutrin or other medication that may lower the seizure threshold.
• Claustrophobia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS Treatment Group	Transcranial direct current stimulation	15 sessions active Transcranial direct current stimulation (tDCS) treatment
TMS Sham Group	Transcranial magnetic stimulation	15 sessions sham Transcranial magnetic stimulation (TMS) treatment
TMS Treatment Group	Transcranial magnetic stimulation	15 sessions active Transcranial magnetic stimulation (TMS) treatment
tDCS Sham Group	Transcranial direct current stimulation	15 sessions sham Transcranial direct current stimulation (tDCS) treatment

Primary Outcome Measures

Name	Time	Method
taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI)	3 years	Change in brain activation to taste reward paradigm

Secondary Outcome Measures

Name	Time	Method
Change in self-reported measures related to eating disorder thoughts and behaviors	3 years	Self Assessment

Trial Locations

Locations (1)

University of Colorado Denver and Health Science Center; 🇺🇸 Aurora, Colorado, United States