Pilot Study of an Intervention Involving Cognitive Training and tDCS in Morbidly Obese Subjects

Parc de Salut Mar

Status and phase: Completed; Phase 2

Conditions: Obesity (BMI > 35) and High Blood Pressure; Obesity (BMI > 35) and Dyslipemia; Obesity (BMI > 35) and Diabetes Mellitus; Obesity, Morbid

Treatments: Other: Cognitive Training; Device: transcranial Direct-Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03943979

IMIMFTLC/EC-TDCS OM

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups

Active Control group

Sham Comparator group

Description:

This group will receive CT and sham tDCS each day, for four days.

Treatment:

Other: Cognitive Training

Active group

Active Comparator group

Description:

This group will receive both CT and tDCS, each day, for four days.

Treatment:

Device: transcranial Direct-Current Stimulation (tDCS)

Other: Cognitive Training