Transcranial Treatments in Eating Disorders

July 21, 2016 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver and Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI)
Time Frame: 3 years
Change in brain activation to taste reward paradigm
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported measures related to eating disorder thoughts and behaviors
Time Frame: 3 years
Self Assessment
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-2716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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