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

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ClinicalTrials.gov Identifier: NCT03943979
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Neuroelectrics Corporation
Information provided by (Responsible Party):
Albert Goday Arno, Parc de Salut Mar

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

Condition or disease Intervention/treatment Phase
Obesity, Morbid Obesity (BMI > 35) and Diabetes Mellitus Obesity (BMI > 35) and High Blood Pressure Obesity (BMI > 35) and Dyslipemia Other: Cognitive Training Device: transcranial Direct-Current Stimulation (tDCS) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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)
Masking Description: The difference between the two groups is the tDCS therapy. To mask this difference, the duration time of the session will be the same under both conditions but a standard Sham tDCS protocol will be used for the Active Control group. That is, a 3-sec ramp-up and ramp-down current stimulation, so the subject perceives the current just like the real tDCS, but it is not strong nor durable enough to have any effect on the neuronal activity.
Primary Purpose: Treatment
Official Title: Pilot Study of an Intervention Involving Cognitive Training and Transcranial Direct-current Stimulation (tDCS) in Morbidly Obese Subjects
Actual Study Start Date : February 25, 2016
Actual Primary Completion Date : May 26, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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).

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Publications:

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Responsible Party: Albert Goday Arno, Medical doctor, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03943979    
Other Study ID Numbers: IMIMFTLC/EC-TDCS OM
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Vascular Diseases
Cardiovascular Diseases