Enhancing Brain Health by TDCS in Persons with Overweight and Obesity

NCT05228067 | Active Not Recruiting

• 1 other identifier: 172/2021BO1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Resistance; Obesity; Diabetes Type 2

Keywords

tDCS; MRI; hypothalamus; functional connectivity

Outcome Measures

Primary Outcomes (4)

• Change in neuroplasticity

  Fractional anisotropy (FA) of the target network

  20 minutes directly before and after tDCS stimulation

• Change in functional connectivity

  Resting state functional connectivity of the target network

  20 minutes directly before and after tDCS stimulation

• Change in eating behavior

  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

  1 hour after tDCS stimulation

• Change in dopamine-dependent cognitive function

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

  20 minutes after tDCS stimulation

Secondary Outcomes (4)

• Change in subjective ratings

  5 minutes before tDCS stimulation, 5 minutes after tDCS stimulation and 5 minutes after buffet

• Performance during stop-signal task

  task is performed during 25-minutes tDCS stimulation

• Tastiness and healthiness rating of food stimuli

  task is performed immediately after buffet

• Food choice

  task is performed immediately after buffet

Study Arms (3)

Anodal stimulation

ACTIVE COMPARATOR

Anodal tDCS of the hypothalamus network

Device: anodal transcranial direct current stimulation

Cathodal stimulation

ACTIVE COMPARATOR

Cathodal tDCS of the hypothalamus network

Device: cathodal transcranial direct current stimulation

Sham stimulation

SHAM COMPARATOR

Sham tDCS of the hypothalamus network

Device: sham transcranial direct current stimulation

Interventions

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.

Also known as: anodal tDCS, excitatory tDCS

Anodal stimulation

cathodal 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.

Also known as: cathodal tDCS, inhibitory tDCS

Cathodal stimulation

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)

Also known as: sham tDCS

Sham stimulation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Clinic Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity; Diabetes Mellitus, Type 2

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Stimulation protocol is applied in a double blind fashion.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive sham stimulation, anodal stimulation and cathodal stimulation in a pseudo-randomized order on three separate measurement days.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: February 8, 2022
• Study Start: November 8, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)