tDCS Stimulation for Anorexia Nervosa

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Brain injury, Implants, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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. To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game. 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. 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.

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 data supports the effectiveness of the treatment Cerebellar 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 anorexia. Some studies have shown that tDCS can lead to weight gain and improvements in mood and anxiety symptoms, making it a promising complementary treatment for anorexia. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, as it is a non-invasive brain stimulation technique that has been used in various conditions like chronic pain, epilepsy, and depression. While the studies focus on its potential benefits for anorexia nervosa, they do not report significant safety concerns, suggesting it is well-tolerated. ^{1 2 3 4 5}

How does tDCS treatment for anorexia nervosa differ from other treatments?

tDCS (transcranial direct current stimulation) is unique because it is a non-invasive brain stimulation technique that aims to balance brain activity by using electrodes placed on the scalp. Unlike traditional treatments like medication or psychotherapy, tDCS directly targets brain regions associated with anorexia, potentially improving eating behaviors and body image. ^{2 3 4 5 6}

Eligibility Criteria

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 have been diagnosed with Anorexia Nervosa.

I am between 15 and 30 years old.

I am a female.

Exclusion Criteria

Pregnancy

I have had a brain injury that needed medical attention.

I have a hearing or visual impairment.

Trial Timeline

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)

Treatment Details

Interventions

• Cerebellar tDCS Stimulation (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Findings from Research

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex improves anorexia nervosa: A pilot study. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

New Treatment Perspectives in Adolescents With Anorexia Nervosa: The Efficacy of Non-invasive Brain-Directed Treatment. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Transcranial Direct Current Stimulation Treatment for Anorexia Nervosa. [2021]

5. England 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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