Brain Stimulation + Cognitive Training for Anorexia

Overseen by Lisa Anderson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Minnesota

Disqualifiers: Substance abuse, Neurological condition, Serious psychiatric disorder, Medical instability, tDCS contraindication, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study looks at adults with restrictive eating disorders who are currently receiving outpatient treatment for their eating disorder to examine whether a new brain stimulation technique called non-invasive transcranial direct current stimulation (tDCS) can enhance brain training. Participation involves interviews, assessments, 10 sessions of brain stimulation (active or sham), and computerized brain training over a 3-4 week period, with one post-intervention visit, and one 1-month follow-up visit.

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 tDCS for anorexia?

Research suggests that tDCS, a non-invasive brain stimulation technique, may help improve weight gain and reduce some symptoms of anorexia, such as the need for strict dietary control and body image issues. Studies have shown that tDCS can alter brain activity, which might help balance brain function and support better eating behaviors in people with 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 and has been used in various conditions like depression and chronic pain. It is a non-invasive method, meaning it doesn't require surgery or entering the body, and studies have shown it can be safely applied in people with anorexia nervosa. ^{1 2 4 5 6}

How does the treatment of brain stimulation and cognitive training for anorexia differ from other treatments?

This treatment is unique because it uses transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, to target brain areas associated with anorexia. Unlike traditional treatments that focus on nutrition and psychotherapy, tDCS aims to balance brain activity, potentially improving eating behaviors and mood by altering brain function. ^{1 2 3 4 6}

Research Team

Lisa Anderson

Principal Investigator

University of Minnesota

Eligibility Criteria

Adults with restrictive eating disorders like Anorexia Nervosa, who are currently in outpatient treatment. Participants will undergo interviews and assessments. They must be available for 10 sessions over 3-4 weeks plus follow-up visits.

Inclusion Criteria

Self-reported enrollment in outpatient-level treatment at local eating disorder treatment centers in the Twin Cities region, meeting DSM-5 criteria for AN (mild severity, based on BMI greater than or equal to 17.0 kg/m2) or atypical AN diagnosis

Sufficient spoken English to comprehend testing procedures

Normative ranges on a C-RENAL blood panel

Exclusion Criteria

Substance abuse

Moderate, severe or extreme AN diagnostic severity based on BMI

tDCS contraindication

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 10 sessions of brain stimulation (active or sham) and computerized brain training over a 3-4 week period

3-4 weeks

10 sessions (in-person)

Post-intervention

One post-intervention visit to assess outcomes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• tDCS (Behavioural Intervention)

Trial Overview The study tests if brain stimulation using a StarStim device can improve the effectiveness of computerized brain training. Participants receive either real (active) tDCS or fake (sham) sessions to compare outcomes.

Participant Groups

Group I: Active tDCS Experimental Treatment 1 Intervention

10 Active tDCS sessions: 10 active sessions of transcranial direct current stimulation paired with cognitive training tasks. Device used is StarStim.

Group II: Sham (fake) tDCS Placebo Group 1 Intervention

10 Sham (fake) tDCS sessions: 10 fake sessions of transcranial direct current stimulation paired with cognitive training tasks. The device will be on the participants head, but the current will not be active.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

3. 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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Effects of transcranial direct current stimulation (tDCS) on binge eating disorder. [2022]