Transcranial Treatments in Eating Disorders

Anorexia Nervosa Clinical Trial

Official title:

Novel Transcranial Treatments to Modulate Taste Reward and Body Perception Pathways in Eating Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02535780
• Other study ID #: 13-2716
• Status: Terminated
• Phase: N/A
• First received: August 6, 2015
• Last updated: July 21, 2016
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

Procedure:
• Transcranial magnetic stimulation
TMS
• Transcranial direct current stimulation
tDCS

Locations

Country	Name	City	State
United States	University of Colorado Denver and Health Science Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI)	Change in brain activation to taste reward paradigm	3 years	No
Secondary	Change in self-reported measures related to eating disorder thoughts and behaviors	Self Assessment	3 years	No