tDCS + Cognitive Training for Obesity

Overseen By Lisa E Keacher, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Seizures, Head injury, Neurological disorder, others

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

Compensation: Varies

Number of Visits: 13

Duration: 3 weeks

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial direct current stimulation (tDCS) can enhance cognitive training to reduce impulsivity in people with obesity. Participants will receive either active tDCS or a sham version, both alongside cognitive training, to assess their impact on weight management. The trial aims to develop new methods to help people with obesity manage their weight. Veterans enrolled in a weight management program at the Minneapolis VA Health Care System who are obese and interested in new treatment methods are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for obesity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled diabetes or hypothyroidism, you may not be eligible to participate.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for cognitive training in individuals with obesity?

Research shows that transcranial direct current stimulation (tDCS) is generally safe. Studies have found that typical tDCS sessions—lasting up to 40 minutes with a current of 4 mA or less—have not caused any serious side effects. Most people handle the treatment well.

While the effects of tDCS on obesity remain unclear, its safe use in other areas is encouraging for potential trial participants. This suggests that tDCS is likely to be safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial direct current stimulation (tDCS) combined with cognitive training for obesity because it offers a non-invasive approach that targets the brain's role in food cravings and decision-making. Unlike standard treatments for obesity, which often focus on diet, exercise, or medication, tDCS directly influences neural activity by applying a small electrical current to the scalp. This technique is thought to enhance cognitive training by boosting brain plasticity, potentially leading to more effective and lasting changes in behavior related to weight management.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare the effects of active transcranial direct current stimulation (tDCS) with cognitive training to sham tDCS with cognitive training. Research has shown that tDCS might help people eat fewer calories. In one study, participants consumed 14.2% fewer calories after 8 days of tDCS sessions. Another study found that tDCS could reduce cravings for sweet foods. While the effectiveness of tDCS for weight loss remains uncertain, it is considered safe when combined with other obesity management methods. Researchers continue to explore the best way to use tDCS for obesity. ^{2 6 7 8 9}

Who Is on the Research Team?

Shalamar D Sibley, MD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

This trial is for veterans with obesity (BMI>30) who are enrolled in the MOVE! program at Minneapolis VA, aged 18-80, and can understand English. Women of childbearing age must agree to use birth control. Exclusions include substance abuse, severe medical/psychological conditions, history of seizures or head injury, metal implants in the head, pregnancy, certain metabolic disorders or uncontrolled diabetes.

Inclusion Criteria

Veteran enrolled in the MOVE! Weight Management Program at the Minneapolis VA Health Care System

Able to understand English, self-consent and follow study-related procedures

I am willing to use birth control during the trial.

Exclusion Criteria

Metal in head (other than in mouth) including shrapnel/surgical clips/welding fragments

I do not have conditions like Cushing's, untreated thyroid issues, or uncontrolled diabetes.

I have hypothyroidism but am on a stable thyroid medication with normal recent tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham tDCS stimulation with cognitive training over ten sessions completed in three weeks

3 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in impulsivity and weight at follow-up visits

4 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active Transcranial Direct Current Stimulation (tDCS)
• Sham Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, alongside cognitive training can reduce impulsivity and help manage weight in obese individuals. Participants will receive either active tDCS or a sham (placebo) treatment.

How Is the Trial Designed?

Group I: Active tDCS with Cognitive Training Experimental Treatment 1 Intervention

Participants will receive active tDCS stimulation with their cognitive training during a one-hour session each day which includes 20 minutes of stimulation at the beginning of a 46-minute task training session. Ten sessions will be completed over three weeks.

Group II: Sham tDCS with Cognitive Training Placebo Group 1 Intervention

Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 seconds, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The NeuroStim-Obesity trial is investigating the effects of transcranial direct current stimulation (tDCS) on food cravings in 64 adults with obesity or overweight, aiming to understand how it can modulate brain responses to food cues.

The primary outcome is to measure changes in neural responses in the ventral striatum after tDCS, which could lead to personalized interventions for obesity by identifying predictive biomarkers for treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to modulate brain reactivity to food cues in overweight and obese adults: study protocol for a randomized controlled trial with fMRI (NeuroStim-Obesity). Ghobadi-Azbari, P., Malmir, N., Vartanian, M., et al.[2022]

Anodal transcranial direct current stimulation (tDCS) to the left dorsolateral prefrontal cortex (dlPFC) improved food-related inhibitory control in individuals with obesity, as shown by better performance on a Go/No-Go task after 15 sessions.

While tDCS reduced snack food intake and hunger, the exact neurocognitive mechanisms behind these changes remain unclear, indicating potential for neuromodulation as a therapeutic approach for obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved food Go/No-Go scores after transcranial direct current stimulation (tDCS) to prefrontal cortex in a randomized trial. Stinson, EJ., Travis, KT., Magerowski, G., et al.[2022]

Transcranial direct current stimulation (tDCS) shows potential for reducing food cravings by modulating brain activity, particularly in the dorsolateral prefrontal cortex, based on findings from three small clinical trials.

Despite promising results in decreasing cravings, the application of tDCS for treating obesity is still largely unexplored, highlighting the need for further research to understand its mechanisms and effectiveness in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating tDCS into the field of obesity: mechanism-driven approaches. Alonso-Alonso, M.[2021]

In a study involving 23 individuals with obesity, short-term anodal tDCS targeting the left dorsolateral prefrontal cortex did not lead to immediate changes in food intake or weight compared to sham stimulation.

However, after 15 sessions of anodal tDCS, participants reported significantly lower hunger and reduced snack food intake, suggesting that longer-term stimulation may help in managing appetite in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial. Heinitz, S., Reinhardt, M., Piaggi, P., et al.[2023]

Transcranial direct current stimulation (tDCS) can effectively modulate brain activity related to food cravings and intake, showing promise for obesity treatment.

The study found that while subcutaneous fat affects current density during tDCS, the standard dosing parameters for tDCS used in the general population are still appropriate for obese individuals, ensuring both efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational modeling of transcranial direct current stimulation (tDCS) in obesity: Impact of head fat and dose guidelines. Truong, DQ., Magerowski, G., Blackburn, GL., et al.[2021]

In a study involving 9 healthy volunteers with obesity, anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (LDLPFC) led to a significant reduction in energy intake and greater weight loss compared to cathodal tDCS.

The findings suggest that stimulating the LDLPFC with anodal tDCS may enhance control over eating behaviors, indicating a potential new approach for weight management in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity. Gluck, ME., Alonso-Alonso, M., Piaggi, P., et al.[2019]

This trial will investigate the effects of combining active transcranial direct current stimulation (tDCS) with a hypocaloric diet on weight loss in overweight or obese adults over a 4-week period, involving 20 sessions of tDCS.

The primary outcome is weight loss, with additional assessments on dietary adherence, energy consumption, and changes in blood glucose and insulin levels, aiming to determine if tDCS can enhance the effectiveness of dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial direct current stimulation associated with hypocaloric diet on weight loss and metabolic profile in overweight or obesity: study protocol for a double-blind, randomized controlled clinical trial. Araujo, C., Fitz, RC., Nogara, DA., et al.[2019]

Transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (DLPFC) did not effectively reduce food craving or consumption compared to stimulation of the sensorimotor cortex (SMC), suggesting that this method may not be a viable treatment for obesity.

Despite 71% of participants being unable to distinguish between the real and control conditions, the lack of efficacy raises questions about the role of tDCS in appetite regulation and highlights the need for better control methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial direct current stimulation (tDCS) on food craving and eating when using a control method that minimizes guessing of the real vs. control condition. Stevens, CE., Lausen, MA., Wagstaff, LE., et al.[2021]

In a pilot study involving 28 adults with overweight or obesity, repetitive active transcranial direct current stimulation (tDCS) over the right dorsolateral prefrontal cortex (rDLPFC) combined with a hypocaloric diet significantly reduced fasting plasma glucose and insulin levels compared to a sham treatment.

The study also found an increase in insulin sensitivity in the active tDCS group, suggesting that this noninvasive technique may improve glucose homeostasis, which is particularly relevant for individuals with type 2 diabetes mellitus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation associated with hypocaloric diet on glucose homeostasis in obesity. de Araujo, C., Fitz, RC., da Natividade, GR., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33183574/

The effect of transcranial direct current stimulation along ... Conclusions: Although this pilot study did not show that repeated tDCS is able to optimize weight loss, it was able to reduce the desire to eat sweet foods.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05609604

Role of Transcranial Direct Current Stimulation in Appetite ... To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite. Detailed Description. To compare weight loss over one month in ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2776-3

Effect of transcranial direct current stimulation associated with ... In another study, a 14.2% reduction in the amount of calories ingested was observed after 8 consecutive days of active tDCS sessions. The ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213158213000673

Impact of head fat and dose guidelines These data suggest potential clinical applications for tDCS in the field of obesity. However, optimal stimulation parameters in obese individuals are uncertain.

5. journal.ppcr.org journal.ppcr.org/index.php/ppcrjournal/article/view/183?articlesBySameAuthorPage=15

A systematic review on transcranial direct current stimulation ... The results reinforce the safety of this technique and point to a positive effect of the association of tDCS with other strategies for the management of obesity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9003175/

Transcranial direct current stimulation to modulate brain ... The NeuroStim-Obesity trial is a prospective, randomized, sham-controlled, double-blind single-session tDCS trial targeting food craving in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04218383

Transcranial Direct Current Stimulation for Impulsivity and ... In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe non-invasive method for modulating the activity ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or ...

9. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06234-8

Transcranial direct current stimulation to modulate brain ... This protocol describes a clinical trial that investigates the neurocognitive mechanisms of action for tDCS to modulate food cue-reactivity and cravings in ...