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

May 8, 2019 updated by: Albert Goday Arno, Parc de Salut Mar

Pilot Study of an Intervention Involving Cognitive Training and Transcranial Direct-current Stimulation (tDCS) in Morbidly Obese Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Active Control group
This group will receive CT and sham tDCS each day, for four days.
Other: Cognitive Training
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.
Active Comparator: Active group
This group will receive both CT and tDCS, each day, for four days.
Other: Cognitive Training
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.
Device: transcranial Direct-Current Stimulation (tDCS)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in food intake
Time Frame: 4 consecutive days during the week before starting the treatment; 4 consecutive days during the week of treatment;
Changes in food consumption (medium kcal intake ) from baseline to the end of the treatment measured by 4-day food registers during the week before starting the treatment and during the 4 days of treatment. The dietary records were checked by a nutritionist and analyzed through the software PCN Pro 1.0.
4 consecutive days during the week before starting the treatment; 4 consecutive days during the week of treatment;
Stability of changes in food intake
Time Frame: 4 consecutive days during the week before starting the treatment and 4 consecutive days during the week after finishing the treatment
Changes in food consumption (medium kcal intake ) from baseline to the follow-up assessment measured by 4-day food registers during the week before starting the treatment and the week after finishing the treatment. The dietary records were checked by a nutritionist and analyzed through the software PCN Pro 1.0.
4 consecutive days during the week before starting the treatment and 4 consecutive days during the week after finishing the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in electroencephalogram (EEG) power and coherence
Time Frame: Every training session (4 consecutive days), 3 minutes before starting the training session and 3 minutes after finishing the training.
EEG was recorded before and after tCS/sham using a Starstim device (Neuroelectrics), same electrode positions as for the stimulation with a sampling frequency of 500 S/s . Electrode impedance: below 10kΩ; electrical reference placed at the right earlobe. EEG data was analyzed offline by means of customized Matlab code (MathWorks Inc. Natick, MA, USA). Data was split into 1s non-overlapping epochs (epochs with amplitudes >50 μV were rejected). EEG-metrics extracted: EEG-power and coherence. To compute EEG power, the power spectral density (PSD) was estimated for each epoch. Band Power was computed for the bands θ=[4,8 Hz], α=[8,13 Hz] β=[13,25 Hz], γ=[30, 45 Hz] and broadband=[4-45Hz] by integrating the PSD within the band frequency limits. Functional connectivity was estimated by means of coherence by the Welch method averaged over all electrodes. Frontal asymmetry (FA) computed as follows: log(avg(AF4 F4 F8 FC6))-log(avg(AF3 F3 F7 FC5); FA<0 reflects dominance of left-hemisphere
Every training session (4 consecutive days), 3 minutes before starting the training session and 3 minutes after finishing the training.
Change in Body Mass Index (BMI)
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in BMI. BMI calculation: body weight divided by the square of the body height (expressed in units of kg/m2). Weight and height measures were taken by a nurse.
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in endocannabinoids (and related compounds) plasmatic concentrations.
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in endocannabinoids and related compounds (acylglycerols and fatty acid N-acylethanolamides) as measured in plasmatic concentrations and quantified by LC/MS-MS by a previously validated method (Pastor et al. 2014).
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in hormonal measurements : Leptin and adiponectin plasmatic/serum concentrations
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Measurement of change in hormones regulating the appetite and energic homeostasis of secretion in fatty tissues.
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in neuropsychological test: Intra-extra dimension (IED-CANTAB Cambridge Cognition)
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Executive functions: flexibility
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in neuropsychological test: Stroop Colours and Words test (SCWT, Golden C.J., 1978; Stroop, 1935)
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Executive functions: inhibition
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in neuropsychological test: Iowa Gambling Task (IGT, Bechara et al., 1994, 2002)
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Executive functions: decision-making, risky behaviour.
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in neuropsychological test: Spatial Span (SSP; CANTAB Cambridge Cognition)
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Executive functions: working memory
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in neuropsychological test: Stockings of Cambridge (SOC; CANTAB Cambridge Cognition)
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Executive functions: planning
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in neuropsychological test: Conners Continuous Performance Test (CPT, Conners & MHS Staff, 2000)
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Executive functions: Attention
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in neuropsychological test: Simple Reaction Time (SRT; CANTAB Cambridge Cognition)
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Executive functions: Attention
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Change in neuropsychological test:Symbol digit modalities test (SDMT; Smith A. 1982).
Time Frame: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)
Executive functions: Attention and Processing speed
One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

Neuroelectrics Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2016

Primary Completion (Actual)

May 26, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMIMFTLC/EC-TDCS OM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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