Anorexia NervosaNCT06286930
Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder
A study testing anodal trans cranial direct current stimulation (tDCS) and cathodal trans cranial direct current stimulation (tDCS) in people with Anorexia Nervosa, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- anodal trans cranial direct current stimulation (tDCS) and cathodal trans cranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 2 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Multispecialty Psychiatry Clinic
Dallas, Texas, 75247
Haley A Walker, Masters, 214-648-4145, haley.walker@utsouthwestern.edu
Ava Ryan, Bachelors, 214-648-4145, ava.ryan@utsouthwestern.edu
About this study
Official title: Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder- A Pilot Study
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:
Read more
- To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game.
- 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.
Secondary Outcomes:
1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation.
Read the detailed description
The study will be randomized, single blind design. It will involve a group of 15 female participants ranging in the ages of 15-30 years old diagnosed with Anorexia Nervosa. Diagnosis will be confirmed by recruitment methods of in-clinic referrals. Each participant will undergo the two different electrode stimulations of the tDCS. Each participant will get anodal and cathodal stimulation. The participants will be unaware of which one they are getting during stimulation, but the researcher will be informed of which stimulation is occurring. The participant will receive 1mA stimulation of the tDCS for 20 minutes in the MRI scanner. After the stimulation is complete in the scanner, the participant will be asked to complete tasks in the scanner as well. The study involves initial screening to determine eligibility to participate. Once eligibility criteria is met, the participant will sign consent via DocUSign. After this virtual visit is complete, the participant will be asked to come in for intake visit. At the intake, the participant will undergo a series of questionnaires and tasks to complete as part of pre-scanning. The next session will be stimulation and MRI imaging. Participant will undergo resting state and a structural scan. After the scans are complete, the participant will receive 20 minutes of tDCS stimulation. After the simulation is complete the participant will be asked to engage in tasks in the scanner. Finally, after the scanning session, the participant will come back for a post session that is the same as the intake and undergo questionnaires and tasks to complete. After the post session, researchers will reach out to participants one week and one month after MRI imaging to go over safety questionnaire of the tDCS. The participant will have a total of 5 sessions which may include both in-person and/or virtual visits with screening session, first session, second session, one week follow-up session, and one-month follow-up session.
- Conditions
- Anorexia Nervosa
- Being tested
- anodal trans cranial direct current stimulation (tDCS), cathodal trans cranial direct current stimulation (tDCS)
- Keywords
- transcranial direct current stimulation, Adolescents, Adults, tDCS
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal trans cranial direct current stimulation (tDCS)Device
1 20-minute anodal tDCS stimulation
cathodal trans cranial direct current stimulation (tDCS)Device
1 20-minute cathodal tDCS stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: anodal trans cranial direct current stimulation (tDCS); Device: cathodal trans cranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (5)
measure the differences of social stimuli and eating disorder/depressive symptomology
To observe potential increases in responses to social stimuli, decreases in eating
disorder/depressive symptomology via transcranial direct current stimulation.
Measured: 1 year
measure the differences of social stimuli and eating disorder/depressive symptomology
To observe potentially little to no changes in social stimuli and eating disorder/depressive symptomology via transcranial direct current stimulation.
Measured: 1 year
measuring the differences of social stimuli and eating disorder/depressive symptomology measuring using the Food Rating Task.
After receiving transcranial direct current stimulation, it is predicted that after stimulation, there will be differences in how the participant will choose certain food items. It suggests that the experience of tastiness changes over time and may contribute to perpetuation of anorexia nervosa.
Measured: 1 year
measure the differences of social stimuli and mental flexibility with Trail Making Task
To observe after transcranial direct current stimulation, if there are differences in mental flexibility with participants with anorexia nervosa. The Trail Making Task A is a measure of simple visual attention, scanning, and psychomotor speed. In contrast, Trail Making Task B is a measure of complex/divided visual attention, and mental flexibility.
Measured: 1 year
measure the differences of social stimuli and eating disorder/depressive symptomology utilizing Patient Health Questionnaire-9.
To observe the differences in self-report answers after stimulation.PHQ-9 observes depression severity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start24 Apr 2024
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie McAdams, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286930
- Sponsor's protocol ID
- STU-2023-0470
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder- A Pilot Study
- ClinicalTrials.gov ID
- NCT06286930
- Acronym / sponsor ID
- STU-2023-0470
- Conditions
- Anorexia Nervosa
- Keywords
- transcranial direct current stimulation, Adolescents, Adults, tDCS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game.
- 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.
Secondary Outcomes:
1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation.
Detailed description
The study will be randomized, single blind design. It will involve a group of 15 female participants ranging in the ages of 15-30 years old diagnosed with Anorexia Nervosa. Diagnosis will be confirmed by recruitment methods of in-clinic referrals. Each participant will undergo the two different electrode stimulations of the tDCS. Each participant will get anodal and cathodal stimulation. The participants will be unaware of which one they are getting during stimulation, but the researcher will be informed of which stimulation is occurring. The participant will receive 1mA stimulation of the tDCS for 20 minutes in the MRI scanner. After the stimulation is complete in the scanner, the participant will be asked to complete tasks in the scanner as well. The study involves initial screening to determine eligibility to participate. Once eligibility criteria is met, the participant will sign consent via DocUSign. After this virtual visit is complete, the participant will be asked to come in for intake visit. At the intake, the participant will undergo a series of questionnaires and tasks to complete as part of pre-scanning. The next session will be stimulation and MRI imaging. Participant will undergo resting state and a structural scan. After the scans are complete, the participant will receive 20 minutes of tDCS stimulation. After the simulation is complete the participant will be asked to engage in tasks in the scanner. Finally, after the scanning session, the participant will come back for a post session that is the same as the intake and undergo questionnaires and tasks to complete. After the post session, researchers will reach out to participants one week and one month after MRI imaging to go over safety questionnaire of the tDCS. The participant will have a total of 5 sessions which may include both in-person and/or virtual visits with screening session, first session, second session, one week follow-up session, and one-month follow-up session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS, then cathodal tDCS | Experimental | Device: anodal trans cranial direct current stimulation (tDCS), Device: cathodal trans cranial direct current stimulation (tDCS)Participants receive 1, 20-minute anodal tDCS stimulation. After a washout period of 2-3 weeks, then receive 1, 20-minute cathodal tDCS stimulation. |
| cathodal tDCS, then andoal tDCS | Experimental | Device: anodal trans cranial direct current stimulation (tDCS), Device: cathodal trans cranial direct current stimulation (tDCS)Participants receive 1, 20-minute cathodal tDCS stimulation. After a washout period of 2-3 weeks, then receive 1, 20-minute anodal tDCS stimulation. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Pregnancy
- Known history of traumatic brain injury that required medical care
- Non-English speaking (based on standardized neuropsychological testing and questionnaires)
- Claustrophobic
- Brain Implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anodal trans cranial direct current stimulation (tDCS)1 20-minute anodal tDCS stimulation | Device | anodal tDCS, then cathodal tDCS, cathodal tDCS, then andoal tDCS |
| cathodal trans cranial direct current stimulation (tDCS)1 20-minute cathodal tDCS stimulation | Device | anodal tDCS, then cathodal tDCS, cathodal tDCS, then andoal tDCS |
Primary outcome
tDCS impact on social behaviors using Cyberball
Time frame: 1 year
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).
tDCS impact on social behaviors using the Trust Game
Time frame: 1 year
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.
neurological impacts of tDCS as measured by fMRI imaging
Time frame: 1 year
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.
5 secondary outcomes
measure the differences of social stimuli and eating disorder/depressive symptomology
Time frame: 1 year
measure the differences of social stimuli and eating disorder/depressive symptomology
Time frame: 1 year
measuring the differences of social stimuli and eating disorder/depressive symptomology measuring using the Food Rating Task.
Time frame: 1 year
measure the differences of social stimuli and mental flexibility with Trail Making Task
Time frame: 1 year
measure the differences of social stimuli and eating disorder/depressive symptomology utilizing Patient Health Questionnaire-9.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anodal trans cranial direct current stimulation (tDCS) and cathodal trans cranial direct current stimulation (tDCS) in people with Anorexia Nervosa, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Walker (214-648-4617, haley.walker@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tDCS impact on social behaviors using Cyberball (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.