Pilot Study of an Intervention Involving Cognitive Training and tDCS in Morbidly Obese Subjects
Condition: Obesity, Morbid; Obesity (BMI > 35) and Diabetes Mellitus; Obesity (BMI > 35) and High Blood Pressure; Obesity (BMI > 35) and Dyslipemia
MeSH terms: Hypertension; Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 2

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
    

Detailed description: 
      The study will explore the impact of a 4-day intervention with either CT (Active control
      condition) or CT+tDCS (Active condition) stimulation on food intake in a sample of morbidly
      obese patients, as measured by dietary assessments the week before, during and the week after
      the intervention. Additionally, to further understand the neuropsychological and
      neurophysiological basis of its impact, measures of executive function and attention
      performance and EEG recordings, respectively, will be collected. Furthermore, we will explore
      the effect of the intervention on endocannabinoids previously related to eating behaviour.

      The Active Control condition will receive sham stimulation together with CT, through a
      computerized cognitive training platform (Guttmann NeuropersonalTrainer), including different
      tasks with designed to train executive functions and attention. Each session will last
      approximately 30-40 min.

      The Active condition will receive tDCS stimulation (20 min, multichannel with an excitatory
      target over the r-dlPFC) together with CT (same as for the Active Control condition).

      Participants will undergo a basal (the week before intervention) and a post treatment
      assessments (the day after finishing the intervention) that will include medical history,
      blood testing, anthropometric measures, a cognitive assessment battery and a 4-day dietary
      assessment.
    

Intervention name(s): Cognitive Training; transcranial Direct-Current Stimulation (tDCS)
Intervention type(s): Other; Device
Intervention description(s): Cognitive Training (CT): 4 consecutive days, 30-45 min session involving 5 different tasks designed to train executive functions and attention, available at the Guttmann Neuropersonaltrainer platform (computerized cognitive training tool certified by the Spanish Agency for Medicines and Health Products as a Class I Health Product). The difficulty level of all the tasks was automatically adjusted on a trial-by-trial basis for both Active and Active Control conditions.; tDCS: 4 consecutive days, 20 min session, delivered through multichannel tDCS (Starstim, Neuroelectrics), with an excitatory target over the r-dlPFC, and an inhibitory target on the contralateral lobe (l-dlPFC). The positioning of the multichannel tCS (electrode location and currents) was solved using the Stimweaver (Ruffini 2013). The resulting tCS montage employed 8 gelled Ag/AgCl electrodes of π cm2 size (Pistim, Neuroelectrics) placed at AF3(-1093uA), AF4 (1178uA), F3 (-1161uA), F4 (1104uA), F7 (-414uA), F8 (530uA), FC5 (1189uA), FC6 (-1332uA).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active Control group: Subjects will receive CT and sham tDCS during four consecutive days.
Active group: Subjects will receive CT and active tDCS during four consecutive days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment