Transcranial Treatments in Eating Disorders

Study Overview
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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.

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

Conditions
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Anorexia Nervosa, Bulimia Nervosa

Intervention / Treatment
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* Procedure: Transcranial magnetic stimulation
* Procedure: Transcranial direct current stimulation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS Treatment Group<br>15 sessions active Transcranial magnetic stimulation (TMS) treatment | Procedure: Transcranial magnetic stimulation<br>* TMS<br>|
| Sham Comparator: TMS Sham Group<br>15 sessions sham Transcranial magnetic stimulation (TMS) treatment | Procedure: Transcranial magnetic stimulation<br>* TMS<br>|
| Experimental: tDCS Treatment Group<br>15 sessions active Transcranial direct current stimulation (tDCS) treatment | Procedure: Transcranial direct current stimulation<br>* tDCS<br>|
| Sham Comparator: tDCS Sham Group<br>15 sessions sham Transcranial direct current stimulation (tDCS) treatment | Procedure: Transcranial direct current stimulation<br>* tDCS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI) | 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 | Self Assessment | 3 years |