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Transcranial Treatments in Eating Disorders

Primary Purpose

Anorexia Nervosa, Bulimia Nervosa

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial magnetic stimulation

Transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Colorado Denver and Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

TMS Treatment Group

TMS Sham Group

tDCS Treatment Group

tDCS Sham Group

Arm Description

15 sessions active Transcranial magnetic stimulation (TMS) treatment

15 sessions sham Transcranial magnetic stimulation (TMS) treatment

15 sessions active Transcranial direct current stimulation (tDCS) treatment

15 sessions sham Transcranial direct current stimulation (tDCS) treatment

Outcomes

Primary Outcome Measures

taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI)

Change in brain activation to taste reward paradigm

Secondary Outcome Measures

Change in self-reported measures related to eating disorder thoughts and behaviors

Self Assessment

Full Information

NCT ID

NCT02535780

First Posted

August 6, 2015

Last Updated

July 21, 2016

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT02535780

Brief Title

Transcranial Treatments in Eating Disorders

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Terminated

Why Stopped

Study procedures and time not feasible due to patient schedule

Study Start Date

August 2015 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa, Bulimia Nervosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TMS Treatment Group

Arm Type

Experimental

Arm Description

15 sessions active Transcranial magnetic stimulation (TMS) treatment

Arm Title

TMS Sham Group

Arm Type

Sham Comparator

Arm Description

15 sessions sham Transcranial magnetic stimulation (TMS) treatment

Arm Title

tDCS Treatment Group

Arm Type

Experimental

Arm Description

15 sessions active Transcranial direct current stimulation (tDCS) treatment

Arm Title

tDCS Sham Group

Arm Type

Sham Comparator

Arm Description

15 sessions sham Transcranial direct current stimulation (tDCS) treatment

Intervention Type

Procedure

Intervention Name(s)

Transcranial magnetic stimulation

Intervention Description

TMS

Intervention Type

Procedure

Intervention Name(s)

Transcranial direct current stimulation

Intervention Description

tDCS

Primary Outcome Measure Information:

Title

taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI)

Description

Change in brain activation to taste reward paradigm

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Change in self-reported measures related to eating disorder thoughts and behaviors

Description

Self Assessment

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guido K. Frank, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Denver and Health Science Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Transcranial Treatments in Eating Disorders

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