Brain Stimulation + Cognitive Training for Anorexia

Overseen By Maya Day

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Minnesota

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

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

Compensation: Varies

Number of Visits: 12

Duration: 3-4 weeks

20 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), which might enhance brain training for individuals with restrictive eating disorders like anorexia. Participants will undergo 10 sessions of either active or sham tDCS, combined with computerized brain tasks over several weeks, to assess symptom improvement. The trial seeks adults in the Twin Cities area who are receiving outpatient treatment for anorexia and have a specific diagnosis. As a Phase 1 trial, this research aims to understand how this new treatment works in people, offering participants the opportunity to be among the first to receive it.

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 this brain stimulation technique is safe for humans?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. Studies have found that side effects are usually mild. Some people might experience headaches, nausea, or drowsiness. These effects are uncommon and typically short-lived. Additionally, tDCS has been used safely for other conditions. Overall, evidence suggests that most people tolerate tDCS well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for anorexia involve therapy and medication aimed at improving mental health and managing symptoms. However, the new approach using transcranial direct current stimulation (tDCS) is unique because it directly targets brain activity. This method involves a non-invasive technique that uses electrical currents to stimulate specific brain regions, potentially enhancing the effectiveness of cognitive training. Researchers are excited about this treatment because it offers a novel way to address the neurological aspects of anorexia, potentially leading to more effective and faster improvements compared to traditional methods.

What evidence suggests that this brain stimulation technique is effective for anorexia?

In this trial, participants will receive either active or sham transcranial direct current stimulation (tDCS) paired with cognitive training tasks. Research has shown that active tDCS can help reduce symptoms of eating disorders. Specifically, studies found that individuals receiving active tDCS significantly improved their scores on the Eating Attitudes Test, which measures symptoms of eating disorders. Additionally, tDCS has shown promise in addressing binge eating and other eating-related issues. These findings suggest that tDCS, especially when combined with cognitive training, might effectively support treatment for restrictive eating disorders. ^{2 3 4 5 6}

Who Is on the Research Team?

Lisa Anderson

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) significantly reduced cravings for various foods and decreased overall food intake by 11% and preferred food intake by 17.5% in individuals with binge eating disorder (BED), based on a study of 30 adults.

The study suggests that tDCS may enhance cognitive control and reduce the desire for food rewards, indicating its potential as a safe and noninvasive treatment option for BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation (tDCS) on binge eating disorder. Burgess, EE., Sylvester, MD., Morse, KE., et al.[2022]

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38757134/

The efficacy of transcranial direct current stimulation in ... The primary outcome measures include changes in symptoms related to eating disorders, as assessed by the Eating Attitudes Test (EAT-26), ...

2. mdpi.com mdpi.com/2077-0383/14/14/5040

Efficacy of Transcranial Direct Current Stimulation in the ... The primary analysis showed a positive impact of tDCS treatment on EAT-26 scores. Eating disorder symptoms showed a significant reduction in the active tDCS ...

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

The efficacy of transcranial direct current stimulation in ... The primary outcome measures include changes in symptoms related to eating disorders, as assessed by the Eating Attitudes Test (EAT-26), ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05788042

Trial of Enhanced Neurostimulation for Anorexia Expected outcomes include data on the relative effectiveness and acceptability for both treatment modalities in the inpatient and at-home setting (i.e., for at- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124006310

Neuromodulatory techniques in eating disorders: From ... Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) showed promising results in RCTs, managing binge eating ...

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

Effects of Transcranial Direct Current Stimulation Treatment for ... It is assumed to be a safe technique (8–10), and the adverse effects are overall mild. The advantages of this method are low purchase costs and ...