Pilot Study of an Intervention Involving Cognitive Training and tDCS in Morbidly Obese Subjects (NCT03943979) | Clinical Trial Compass
CompletedPhase 2
Pilot Study of an Intervention Involving Cognitive Training and tDCS in Morbidly Obese Subjects
18 participantsStarted 2016-02-25
Plain-language summary
The study aims to: 1) investigate the effects of cognitive training (CT) and combined CT and transcranial direct current stimulation (tDCS) on food intake and 2) to further understand its neuropsychological and neurophysiological basis (i.e. EEG) as well as its impact in endocannabinoids (EC) in a sample of morbidly obese patients seeking for a gastric bypass surgery
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects of both gender, aged between 18 and 60 years-old
* Having a BMI \> 40 kg/m2 or having a BMI\>35 and suffering from diabetes mellitus, HBP or LDP.
* Obesity conventional treatment failure
* Wish of bariatric surgery
* Accepting the study and signing the Informed Consent
Exclusion Criteria:
* Do not meet inclusion criteria
* Being left-handed
* Using a pacemaker or deep cerebral stimulation device
* Having a psychiatric disease or serious disease
* Neurologic condition or learning issue or mental backwardness that could affect cognitive function
* Use of psycho-stimulating medicines and/or drugs, abuse or dependance to a psychoactive substance (or during the last 6 months)
* Dependance to alcohol or/and drugs (excepted from nicotina)
* In treatment with benzodiazepines, antipsychotics, tricyclic antidepressants or topiramate, started in the last month
* History of psychiatric disorders treated with lithio carbonate.
* Cutaneous lesion on the area of using of electrodes
* Contact allergy to material used in the used devices.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in food intake
Timeframe: 4 consecutive days during the week before starting the treatment; 4 consecutive days during the week of treatment;
2
Stability of changes in food intake
Timeframe: 4 consecutive days during the week before starting the treatment and 4 consecutive days during the week after finishing the treatment