tDCS Stimulation for Anorexia Nervosa

Overseen By Haley Walker

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Brain injury, Implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new brain stimulation technique called tDCS (Transcranial Direct Current Stimulation) to determine its effectiveness for women with anorexia nervosa, a condition characterized by restricted eating. The research aims to discover whether this brain stimulation can enhance social interactions and thinking skills when combined with other therapies. Participants will receive two types of brain stimulation, with breaks in between, to compare their effects. Women diagnosed with anorexia nervosa, aged 15 to 30, may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve treatment options for anorexia nervosa.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cerebellar tDCS stimulation is safe for treating anorexia nervosa?

Research has shown that cerebellar transcranial direct current stimulation (tDCS) is generally safe. Studies indicate that side effects are usually mild and manageable. This treatment uses a small electrical current to stimulate the brain and has been tested in both children and adults, including those with anorexia nervosa.

In past studies, participants handled the treatment well without serious side effects. The treatment shows promise in improving social behaviors and may help reduce symptoms of eating disorders like anorexia nervosa. Although more research is needed to fully understand its safety and effectiveness, current evidence suggests it could be a safe option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cerebellar transcranial direct current stimulation (tDCS) for anorexia nervosa because it offers a non-invasive way to potentially alter brain activity associated with the condition. Unlike traditional treatments that involve medications or therapy, tDCS directly targets the brain's electrical activity, which might help improve symptoms more quickly. This technique could offer a new avenue for treatment by directly influencing neural pathways involved in appetite and mood regulation, providing hope for those who haven't found success with existing therapies.

What evidence suggests that cerebellar tDCS stimulation might be an effective treatment for anorexia nervosa?

Research suggests that cerebellar tDCS, a type of brain stimulation, might help manage anorexia nervosa by influencing social behaviors and thinking flexibility. In this trial, participants will receive either cathodal tDCS followed by anodal tDCS or anodal tDCS followed by cathodal tDCS, with a washout period in between. Studies have shown that tDCS can change eating habits and reduce the urge to adhere to strict diets. It might also improve body image perception and support better nutrition. In tests like the Trust Game, tDCS has influenced social interactions, indicating it might assist with understanding social situations. These early findings suggest that tDCS could be promising for addressing some symptoms of anorexia nervosa. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a female.

I have been diagnosed with Anorexia Nervosa.

I am between 15 and 30 years old.

Exclusion Criteria

Pregnancy

I have had a brain injury that needed medical attention.

I have a hearing or visual impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Intake and Pre-Scanning

Participants undergo a series of questionnaires and tasks as part of pre-scanning

1 session

1 visit (in-person)

Stimulation and MRI Imaging

Participants receive 20 minutes of tDCS stimulation and complete tasks in the MRI scanner

1 session

1 visit (in-person)

Post-Session

Participants undergo questionnaires and tasks similar to the intake session

1 session

1 visit (in-person)

Follow-up

Researchers reach out to participants one week and one month after MRI imaging to go over safety questionnaire of the tDCS

1 month

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cerebellar tDCS Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: cathodal tDCS, then andoal tDCS Experimental Treatment 2 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 tDCS Experimental Treatment 2 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.

Cerebellar tDCS Stimulation is already approved in European Union, United States for the following indications:

Approved in European Union as Transcranial Direct Current Stimulation for:

• Anorexia Nervosa
• Depression
• Eating Disorders

Approved in United States as Transcranial Direct Current Stimulation for:

• Anorexia Nervosa
• Depression
• Eating Disorders

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

In a study involving 43 inpatients with anorexia nervosa, transcranial direct current stimulation (tDCS) did not show significant effects on overall eating behaviors or weight recovery, as measured by the Eating Disorder Examination Questionnaire (EDE-Q) and BMI.

However, active tDCS did lead to improvements in self-evaluation of body shape and a reduction in the need for excessive calorie control, suggesting some potential benefits in body image perception despite the lack of significant overall treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Transcranial Direct Current Stimulation Treatment for Anorexia Nervosa. Baumann, S., Mareš, T., Albrecht, J., et al.[2021]

Transcranial direct current stimulation (tDCS) is a promising non-invasive treatment for anorexia, as it can help balance brain activity by increasing excitability in the left prefrontal cortex while suppressing it in the right hemisphere.

The proposed tDCS protocol, combined with nutritional supplements and psychotherapy, suggests that it could be an effective complementary tool for treating anorexia, especially in patients not on SSRIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in the treatment of anorexia. Hecht, D.[2010]

In a pilot study involving 23 adolescents with anorexia nervosa, those receiving transcranial direct current stimulation (tDCS) alongside standard treatment showed significant weight gain after 6 weeks, which was maintained at a 1-month follow-up.

The tDCS treatment specifically improved BMI compared to a control group receiving family-based therapy, suggesting that this neuromodulation technique may effectively target brain mechanisms involved in anorexia nervosa and promote healthier eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Treatment Perspectives in Adolescents With Anorexia Nervosa: The Efficacy of Non-invasive Brain-Directed Treatment. Costanzo, F., Menghini, D., Maritato, A., et al.[2020]

In a study involving seven individuals with treatment-resistant anorexia nervosa, anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex showed potential benefits, with three patients improving in eating and depression scales immediately after treatment and one month later.

The results indicate that tDCS may be an effective adjunct treatment for anorexia nervosa, as significant improvements were observed in depression and eating attitudes, warranting further investigation into its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex improves anorexia nervosa: A pilot study. Khedr, EM., Elfetoh, NA., Ali, AM., et al.[2014]

A randomized, double-blind, placebo-controlled trial will assess the efficacy of transcranial direct current stimulation (tDCS) on 80 children and adolescents (ages 10-18) with Anorexia Nervosa, aiming to improve clinical outcomes and reduce symptoms over six weeks of treatment.

The study will also explore changes in brain mechanisms and biomarkers, including PFC connectivity and stress response, which may provide new insights into effective treatments for Anorexia Nervosa in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of non-invasive brain stimulation in the treatment of children and adolescents with Anorexia Nervosa: study protocol of a randomized, double blind, placebo-controlled trial. Ursumando, L., Ponzo, V., Monteleone, AM., et al.[2023]

Transcranial direct current stimulation (tDCS) shows promise as a non-invasive treatment for anorexia nervosa (AN), with preliminary evidence suggesting it can positively affect eating behavior, body weight, and food intake, as well as reduce depressive symptoms.

The studies reviewed primarily targeted the left dorsolateral prefrontal cortex (DLPFC) and indicate that while the current evidence is limited, tDCS may improve clinical symptoms of AN, highlighting the need for further research with advanced neuroimaging techniques to better understand its mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Transcranial Direct Current Stimulation (tDCS) on Anorexia Nervosa: A Narrative Review. Chmiel, J., Gladka, A., Leszek, J.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06286930

Cerebellar tDCS Stimulation in Children and Adult Women ... To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by the Trust Game. The Trust Game ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10610104/

The Effect of Transcranial Direct Current Stimulation (tDCS) on ... These studies provide preliminary evidence that tDCS has the potential to alter eating behaviour, body weight, and food intake.

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1284675/full

The efficacy of transcranial direct current stimulation in ... The main purpose of the 3-week RCT is to determine the effect of tDCS on the mental state and advances in nutritional rehabilitation in patients with AN.

4. childrens.com childrens.com/research-innovation/clinical-trials/stu-2023-0470

Cerebellar tDCS stimulation in children and adult women ... Clinical Trial. Cerebellar tDCS stimulation in children and adult women with Anorexia Nervosa disorder- A Pilot Study.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8526853/

Effects of Transcranial Direct Current Stimulation Treatment for ... These findings indicate that active tDCS might reduce the urge to follow specific dietary rules and improves self-evaluation based on body shape ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31239105/

Safety and efficacy of transcranial direct current stimulation ... Safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of Anorexia Nervosa. The open-label STAR study.

7. withpower.com withpower.com/trial/phase-anorexia-nervosa-3-2024-5a308

tDCS Stimulation for Anorexia Nervosa Research suggests that transcranial direct current stimulation (tDCS) can help improve body image and reduce the need for strict dietary control in people with ...