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Behavioural Intervention

tDCS Stimulation for Anorexia Nervosa

N/A
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Anorexia Nervosa (AN)
Age 15-30 years old inclusive at time of enrollment
Must not have
Hearing or visual impairment
Known history of traumatic brain injury that required medical care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate if using a type of brain stimulation (tDCS) on the cerebellum can help improve certain behaviors and cognitive functions in women with anorexia nervosa. They

Who is the study for?
This trial is for females aged 15-30 diagnosed with Anorexia Nervosa. If under 18, a parent or guardian must consent. Participants need to sign a HIPAA form, and minors should give assent to join the study.
What is being tested?
The study tests if brain stimulation (tDCS) in the cerebellum helps improve social behavior and cognitive flexibility in women with anorexia nervosa. It includes measuring responses via games and fMRI scans to see changes in brain networks.
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site, itching, tingling, headache, fatigue or nausea during or after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Anorexia Nervosa.
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I am between 15 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a hearing or visual impairment.
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I have had a brain injury that needed medical attention.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
neurological impacts of tDCS as measured by fMRI imaging
tDCS impact on social behaviors using Cyberball
tDCS impact on social behaviors using the Trust Game
Secondary study objectives
measure the differences of social stimuli and eating disorder/depressive symptomology
measure the differences of social stimuli and eating disorder/depressive symptomology utilizing Patient Health Questionnaire-9.
measure the differences of social stimuli and mental flexibility with Trail Making Task
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: cathodal tDCS, then andoal tDCSExperimental Treatment2 Interventions
Participants receive 1, 20-minute cathodal tDCS stimulation. After a washout period of 2-3 weeks, then receive 1, 20-minute anodal tDCS stimulation.
Group II: anodal tDCS, then cathodal tDCSExperimental Treatment2 Interventions
Participants receive 1, 20-minute anodal tDCS stimulation. After a washout period of 2-3 weeks, then receive 1, 20-minute cathodal tDCS stimulation.

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,079 Previous Clinical Trials
1,056,149 Total Patients Enrolled
2 Trials studying Anorexia Nervosa
89 Patients Enrolled for Anorexia Nervosa
~4 spots leftby Jan 2025
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