Clinical trial

Enhancing Brain Health by TDCS in Persons with Overweight and Obesity

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05228067

Active, not recruitingNot applicableInterventional

What this study is about

Disturbances in the hypothalamus communication pathways with other regions in the brain and the periphery may represent a potential link between metabolic and cognitive health. The current project evaluates whether enhancing synaptic plasticity of this pathway can improve weight management, insulin sensitivity, and cognitive functions. In recent studies, we were able to show that the human brain is sensitive to insulin with favorable effects on peripheral metabolism and cognition. These brain regions encompass the hypothalamus and its connections to the striatum and prefrontal cortex. We want to investigate whether it is possible to enhance neuroplasticity of insulin-responsive brain regions to suppress the weight gain trajectory and improve dopamine-dependent cognitive functions in people with a high risk to develop type 2 diabetes. For this purpose, neuroimaging tools using high-definition transcranial direct current stimulation (HD-tDCS) and magnetic resonance imaging (MRI) will be implemented to assess synaptic plasticity of a neural network essential for metabolic and cognitive health.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionInsulin Resistance, Obesity, Diabetes Type 2

Full registry criteria

Inclusion Criteria: * Written consent to participate in the study * Written consent to be informed about incidental findings Overweight and obese participants: * Body mass index (BMI) between 28 and 39.5 kg/m2 * Age between 20 to 65 years of age * Waist circumference \> 80 cm for women, \> 94 cm for men Sex and age matched normal weight individuals: * Body mass index (BMI) between 19.5 and 24.5 kg/m2 * Age between 20 to 65 years of age Exclusion Criteria: * Insufficient knowledge of the German language * Persons who cannot legally give consent * Pregnancy or lactation * History of severe mental or somatic disorders including neurological diseases (incl. Epileptic seizures) * Taking psychotropic drugs * Previous bariatric surgery * Acute infection within the last 4 weeks * Hemoglobin values less than 12g/dl for women, less than 14 g/dl for men * Current participation in a lifestyle intervention study or a pharmaceutical study * Contradictions to a MRI measurement (e.g. metal implants)

Treatments and study arms

anodal transcranial direct current stimulation

Device

anodal tDCS of the hypothalamus resting-state functional connectivity network using 12 Electrodes of the Starstim device by Neuroelectrics. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.

cathodal transcranial direct current stimulation

Device

sham transcranial direct current stimulation

Device

Double blind sham stimulation of the hypothalamus resting-state functional connectivity network (ramp-up ramp-down stimulation will be applied for 30 seconds)

Primary outcomes

Change in neuroplasticity20 minutes directly before and after tDCS stimulation

Fractional anisotropy (FA) of the target network

Change in functional connectivity20 minutes directly before and after tDCS stimulation

Resting state functional connectivity of the target network

Change in eating behavior1 hour after tDCS stimulation

Caloric intake (kcal), Free-choice, ad libitum food intake from a standardized breakfast buffet. The caloric intake from fat, carbohydrates and protein will be documented

Change in dopamine-dependent cognitive function20 minutes after tDCS stimulation

Changes in dopamine-dependent cognitive function and reward sensitivity measured by a reward-based decision-making task

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University Clinic Tübingen🇩🇪 Tübingen, Germany

Open map