Clinical trial NCT03943979: Pilot Study of an Intervention Involving Cognitive Training and tDCS in Morbidly Obese Subjects
Official title: Pilot Study of an Intervention Involving Cognitive Training and Transcranial Direct-current Stimulation (tDCS) in Morbidly Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity, Morbid
Obesity (BMI > 35) and Diabetes Mellitus
Obesity (BMI > 35) and High Blood Pressure
Obesity (BMI > 35) and Dyslipemia
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Neuroelectrics Corporation
First posted: 2019-05-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in food intake
timeFrame: 4 consecutive days during the week before starting the treatment; 4 consecutive days during the week of treatment;
measure: 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
Secondary outcomes:
measure: Change in electroencephalogram (EEG) power and coherence
timeFrame: Every training session (4 consecutive days), 3 minutes before starting the training session and 3 minutes after finishing the training.
measure: Change in Body Mass Index (BMI)
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in endocannabinoids (and related compounds) plasmatic concentrations.
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in hormonal measurements : Leptin and adiponectin plasmatic/serum concentrations
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in neuropsychological test: Intra-extra dimension (IED-CANTAB Cambridge Cognition)
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in neuropsychological test: Stroop Colours and Words test (SCWT, Golden C.J., 1978; Stroop, 1935)
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in neuropsychological test: Iowa Gambling Task (IGT, Bechara et al., 1994, 2002)
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in neuropsychological test: Spatial Span (SSP; CANTAB Cambridge Cognition)
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in neuropsychological test: Stockings of Cambridge (SOC; CANTAB Cambridge Cognition)
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in neuropsychological test: Conners Continuous Performance Test (CPT, Conners & MHS Staff, 2000)
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in neuropsychological test: Simple Reaction Time (SRT; CANTAB Cambridge Cognition)
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
measure: Change in neuropsychological test:Symbol digit modalities test (SDMT; Smith A. 1982).
timeFrame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Other outcomes:
Locations:
Study officials:
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