Role of Transcranial Direct Current Stimulation in Appetite and Weight Control

Study Overview
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Brief Summary
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To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.

Detailed Description
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To compare weight loss over one month in active tDCS group with sham tDCS group. The investigator will measure weight of every participants at the beginning of the study and one month after the last session of tDCS To compare change in insulin sensitivity over one month in active tDCS group with sham tDCS group. The investigator will measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance (HOMA-IR) To compare change in cognitive performance as a response to food over one month in active tDCS group with sham tDCS group. The investigator will evaluate performance in a computerized task that measures executive functions under the presence of food (working memory, inhibitory control and a combination of both). The investigator will assess changes in accuracy and speed in the task under active tDCS versus sham tDCS. To compare change in post-prandial glucose excursion and average meal counts per day. The investigator will use continuous glucose monitor to record the frequency and amplitude of glucose excursion.

Official Title
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Role of Trans-cranial Direct Current Stimulation in Appetite and Weight Control: A Prospective Randomized Study

Conditions
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Weight Loss, Appetite Loss

Intervention / Treatment
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* Device: tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 18 to 80 years of age Body mass index > 30 kg/m2 Exclusion Criteria: Current participation in any other concurrent clinical trials or previous participation within 30 days before the screening visit Pregnancy or premenopausal women who are trying to be pregnant Patients who are incompetent to give consent Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery Have taken any of the following medications within the past 3 months: phentermine, naltrexone, bupropion, topiratmate, lorcaserin, phendimetrazine, methamphetamine, benzphetamine, diethylpropion Any contraindication to receive transcranial direct current stimulation (tDCS): Personal or family history of seizures, epilepsy or other unexplained loss of consciousness. Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.). Prior neurosurgical procedure or radiation. Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, Transcutaneous Electrical Nerve Stimulation unit, ventriculo-peritoneal shunt or any metallic implant on the head.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active tDCS<br>This group will receive 30 minutes of active stimulation from tDCS | Device: tDCS<br>* Electric current will be delivered to the pre-frontal cortex for 30 minutes.<br>|
| Placebo Comparator: sham tDCS<br>This group will receive 30 minutes of sham (placebo) stimulation from tDCS | Device: tDCS<br>* Electric current will be delivered to the pre-frontal cortex for 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in weight | change in weight, measured as a percentage of baseline body weight | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personality | Personality measured by Big Five inventory personality questionnaire. The result presented on a scale from 1 to 10. IF your score was 10 - it means that your trait is stronger than 97,72%. High score correlates with inventiveness and intellectual curiosity, low score correlates with consistency and curiosity | 5 weeks | 
| insulin sensitivity | measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance | 5 weeks | 
| Cognitive response to food measured by computer tasks | response to food over one month in active tDCS group with sham tDCS group | 5 weeks | 
| total Food intake | measured by logbook for number and amount of daily food intake | 5 weeks | 
| Insulin sensitivity | Insulin sensitivity measured by HOMA-IR | 5 weeks | 
| post-prandial glucose excursion | continuous glucose monitor to record the frequency and amplitude of glucose excursion | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, TDCS, Appetite, Weight loss