Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder

NCT06286930 | Recruiting FDA Device

• 1 other identifier: STU-2023-0470
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors, social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies? Primary Outcomes:

1. 1.To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game.
2. 2.To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest (ROI) of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks.

Conditions

Anorexia Nervosa

Keywords

transcranial direct current stimulation; Adolescents; Adults; tDCS

Outcome Measures

Primary Outcomes (3)

• tDCS impact on social behaviors using Cyberball

  To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball. Cyberball is a virtual ball toss game utilized to measure ostracism, social exclusion, rejection, etc. This measure predicts whether or not the behavior of the participant will change how they react to the game after receiving transcranial direct current stimulation (tDCS).

  1 year

• tDCS impact on social behaviors using the Trust Game

  To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by the Trust Game. The Trust Game Examines how expectations about prior behaviors influence current behavior and responses. Using a computational psychiatry approach in which neuroimaging data is sorted based on the behaviors experienced in the game (reciprocity). The prediction is to see after tDCS administration, will the behaviors of the participant change towards the online player in the trust game or not.

  1 year

• neurological impacts of tDCS as measured by fMRI imaging

  To observe the potential re-connection between the cerebellum and the default mode network as well as other areas of the brain during transcranial direct current stimulation measured by fMRI imaging.

  1 year

Secondary Outcomes (5)

• measure the differences of social stimuli and eating disorder/depressive symptomology

  1 year

• measure the differences of social stimuli and eating disorder/depressive symptomology

  1 year

• measuring the differences of social stimuli and eating disorder/depressive symptomology measuring using the Food Rating Task.

  1 year

• measure the differences of social stimuli and mental flexibility with Trail Making Task

  1 year

• measure the differences of social stimuli and eating disorder/depressive symptomology utilizing Patient Health Questionnaire-9.

  1 year

Study Arms (2)

anodal tDCS, then cathodal tDCS

EXPERIMENTAL

Participants receive 1, 20-minute anodal tDCS stimulation. After a washout period of 2-3 weeks, then receive 1, 20-minute cathodal tDCS stimulation.

Device: anodal trans cranial direct current stimulation (tDCS); Device: cathodal trans cranial direct current stimulation (tDCS)

cathodal tDCS, then andoal tDCS

EXPERIMENTAL

Participants receive 1, 20-minute cathodal tDCS stimulation. After a washout period of 2-3 weeks, then receive 1, 20-minute anodal tDCS stimulation.

Device: anodal trans cranial direct current stimulation (tDCS); Device: cathodal trans cranial direct current stimulation (tDCS)

Interventions

cathodal trans cranial direct current stimulation (tDCS) DEVICE

1 20-minute cathodal tDCS stimulation

anodal tDCS, then cathodal tDCS; cathodal tDCS, then andoal tDCS

anodal trans cranial direct current stimulation (tDCS) DEVICE

1 20-minute anodal tDCS stimulation

anodal tDCS, then cathodal tDCS; cathodal tDCS, then andoal tDCS

Eligibility Criteria

• Age: 15 Years - 30 Years
• Gender Eligibility Details: Must be female/ biologically female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Anorexia Nervosa (AN)
• Female participants
• Age 15-30 years old inclusive at time of enrollment
• Ability of parent or legal guardian to provide informed consent if participant is under 18 years old.
• Ability of patients ages 15-17 to give assent to the study.
• Completion of the signed HIPAA authorization form by a parent or legal guardian or by participants (18 years of age).

You may not qualify if:

• Pregnancy
• Known history of traumatic brain injury that required medical care
• Non-English speaking (based on standardized neuropsychological testing and questionnaires)
• Claustrophobic
• Brain Implants
• Pacemakers
• Hearing or visual impairment
• Any biomedical or metal implants in any part of the body (excluding orthopedic implants)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Multispecialty Psychiatry Clinic

Dallas, Texas, 75247, United States

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Central Study Contacts

Haley Walker

CONTACT

214-648-4617; haley.walker@utsouthwestern.edu

Ava Ryan

CONTACT

214-648-4617; Ava.ryan@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 29, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)