Appetite Loss, Weight Loss
Conditions
Keywords
TDCS, Obesity, Appetite, Weight loss
Brief summary
To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.
Detailed description
1. 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 2. 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) 3. 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. 4. 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.
Interventions
DEVICEtDCS
Electric current will be delivered to the pre-frontal cortex for 30 minutes.
DEVICEShame- No current
Sponsors
Harvard Medical School (HMS and HSDM)
University at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 5 weeks | change in body weight in Kg measured from baseline at 5 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS This group will receive 30 minutes of active stimulation from tDCS
tDCS: Electric current will be delivered to the pre-frontal cortex for 30 minutes. | 2 |
| Sham tDCS This group will receive 30 minutes of sham (placebo) stimulation from tDCS
Shame- No current | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 3 | 43 years STANDARD_DEVIATION 5 | 45 years STANDARD_DEVIATION 4 |
| Body mass index (BMI) | 41 Kg/m2 STANDARD_DEVIATION 5 | 38 Kg/m2 STANDARD_DEVIATION 4 | 39.7 Kg/m2 STANDARD_DEVIATION 4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Change in Body Weight
change in body weight in Kg measured from baseline at 5 weeks
Time frame: 5 weeks
Population: no patient completed the study due to study termination due to departure of trained staff.