Transcranial Treatments in Eating Disorders

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02535780
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arms: 4
• Duration (Months): 10
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa; Bulimia Nervosa	Procedure: Transcranial magnetic stimulation; Procedure: Transcranial direct current stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Novel Transcranial Treatments to Modulate Taste Reward and Body Perception Pathways in Eating Disorders
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TMS Treatment Group 15 sessions active Transcranial magnetic stimulation (TMS) treatment	Procedure: Transcranial magnetic stimulation; TMS
Sham Comparator: TMS Sham Group 15 sessions sham Transcranial magnetic stimulation (TMS) treatment	Procedure: Transcranial magnetic stimulation; TMS
Experimental: tDCS Treatment Group 15 sessions active Transcranial direct current stimulation (tDCS) treatment	Procedure: Transcranial direct current stimulation; tDCS
Sham Comparator: tDCS Sham Group 15 sessions sham Transcranial direct current stimulation (tDCS) treatment	Procedure: Transcranial direct current stimulation; tDCS

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in self-reported measures related to eating disorder thoughts and behaviors [3 years]

   Self Assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver and Health Science Center	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Guido K. Frank, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02535780
• Other Study ID Numbers: 13-2716
• First Posted: Aug 31, 2015
• Last Update Posted: Jul 25, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Anorexia; Bulimia; Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa

Study Results

No Results Posted as of Jul 25, 2016