Transcranial Treatments in Eating Disorders

NCT ID: NCT02535780

Last Updated: 2016-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Anorexia Nervosa Bulimia Nervosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TMS Treatment Group

15 sessions active Transcranial magnetic stimulation (TMS) treatment

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type PROCEDURE

TMS

TMS Sham Group

15 sessions sham Transcranial magnetic stimulation (TMS) treatment

Group Type SHAM_COMPARATOR

Transcranial magnetic stimulation

Intervention Type PROCEDURE

TMS

tDCS Treatment Group

15 sessions active Transcranial direct current stimulation (tDCS) treatment

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type PROCEDURE

tDCS

tDCS Sham Group

15 sessions sham Transcranial direct current stimulation (tDCS) treatment

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type PROCEDURE

tDCS

Interventions

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Transcranial magnetic stimulation

TMS

Intervention Type PROCEDURE

Transcranial direct current stimulation

tDCS

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guido K. Frank, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver and Health Science Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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13-2716

Identifier Type: -

Identifier Source: org_study_id

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