AzTrials
AzTrials

Obesity, MorbidPhase 2NCT03943979

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

A Phase 2 study testing Cognitive Training and transcranial Direct-Current Stimulation (tDCS) in people with Obesity, Morbid and Obesity (BMI > 35) and Diabetes Mellitus, run by Parc de Salut Mar.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Cognitive Training and transcranial Direct-Current Stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
No sites listed yet
Study dates
25 Feb 2016to 1 Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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.

About this study

Official title: 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

Read the 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.

Being tested
Cognitive Training, transcranial Direct-Current Stimulation (tDCS)
Medical subject headings
Obesity, Morbid, Obesity, Diabetes Mellitus, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive TrainingOther

    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.

  • transcranial Direct-Current Stimulation (tDCS)Device

    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).

Study groups in NCT03943979
Study groupRoleWhat they receive
Active Control groupSham comparatorThis group will receive CT and sham tDCS each day, for four days.
Receives: Other: Cognitive Training
Active groupActive comparatorThis group will receive both CT and tDCS, each day, for four days.
Receives: Other: Cognitive Training; Device: transcranial Direct-Current Stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in food intake

    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.

    Measured: 4 consecutive days during the week before starting the treatment; 4 consecutive days during the week of treatment;

  2. Stability of changes in food intake

    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.

    Measured: 4 consecutive days during the week before starting the treatment and 4 consecutive days during the week after finishing the treatment

Secondary outcomes (12)

  1. Change in electroencephalogram (EEG) power and coherence

    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

    Measured: Every training session (4 consecutive days), 3 minutes before starting the training session and 3 minutes after finishing the training.

  2. Change in Body Mass Index (BMI)

    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.

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  3. Change in endocannabinoids (and related compounds) plasmatic concentrations.

    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).

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  4. Change in hormonal measurements : Leptin and adiponectin plasmatic/serum concentrations

    Measurement of change in hormones regulating the appetite and energic homeostasis of secretion in fatty tissues.

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  5. Change in neuropsychological test: Intra-extra dimension (IED-CANTAB Cambridge Cognition)

    Executive functions: flexibility

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  6. Change in neuropsychological test: Stroop Colours and Words test (SCWT, Golden C.J., 1978; Stroop, 1935)

    Executive functions: inhibition

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  7. Change in neuropsychological test: Iowa Gambling Task (IGT, Bechara et al., 1994, 2002)

    Executive functions: decision-making, risky behaviour.

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  8. Change in neuropsychological test: Spatial Span (SSP; CANTAB Cambridge Cognition)

    Executive functions: working memory

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  9. Change in neuropsychological test: Stockings of Cambridge (SOC; CANTAB Cambridge Cognition)

    Executive functions: planning

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  10. Change in neuropsychological test: Conners Continuous Performance Test (CPT, Conners & MHS Staff, 2000)

    Executive functions: Attention

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  11. Change in neuropsychological test: Simple Reaction Time (SRT; CANTAB Cambridge Cognition)

    Executive functions: Attention

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

  12. Change in neuropsychological test:Symbol digit modalities test (SDMT; Smith A. 1982).

    Executive functions: Attention and Processing speed

    Measured: One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start25 Feb 2016
  3. Primary completion26 May 2017
  4. Study completion1 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03943979
Sponsor's protocol ID
IMIMFTLC/EC-TDCS OM
Status last verified
May 2019
First submitted
14 Jun 2018
Last updated
9 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Alonso-Alonso M. Translating tDCS into the field of obesity: mechanism-driven approaches. Front Hum Neurosci. 2013 Aug 27;7:512. doi: 10.3389/fnhum.2013.00512. eCollection 2013.

    PubMed 23986687

  • Barr MS, Fitzgerald PB, Farzan F, George TP, Daskalakis ZJ. Transcranial magnetic stimulation to understand the pathophysiology and treatment of substance use disorders. Curr Drug Abuse Rev. 2008 Nov;1(3):328-39. doi: 10.2174/1874473710801030328.

    PubMed 19630729

  • Boivin JR, Piscopo DM, Wilbrecht L. Brief cognitive training interventions in young adulthood promote long-term resilience to drug-seeking behavior. Neuropharmacology. 2015 Oct;97:404-13. doi: 10.1016/j.neuropharm.2015.05.036. Epub 2015 Jun 9.

    PubMed 26066577

  • Conti CL, Moscon JA, Fregni F, Nitsche MA, Nakamura-Palacios EM. Cognitive related electrophysiological changes induced by non-invasive cortical electrical stimulation in crack-cocaine addiction. Int J Neuropsychopharmacol. 2014 Sep;17(9):1465-75. doi: 10.1017/S1461145714000522. Epub 2014 Apr 28.

    PubMed 24776374

  • Corbett A, Owen A, Hampshire A, Grahn J, Stenton R, Dajani S, Burns A, Howard R, Williams N, Williams G, Ballard C. The Effect of an Online Cognitive Training Package in Healthy Older Adults: An Online Randomized Controlled Trial. J Am Med Dir Assoc. 2015 Nov 1;16(11):990-7. doi: 10.1016/j.jamda.2015.06.014.

    PubMed 26543007

  • Ditye T, Jacobson L, Walsh V, Lavidor M. Modulating behavioral inhibition by tDCS combined with cognitive training. Exp Brain Res. 2012 Jun;219(3):363-8. doi: 10.1007/s00221-012-3098-4. Epub 2012 Apr 25.

    PubMed 22532165

  • Gluck ME, Alonso-Alonso M, Piaggi P, Weise CM, Jumpertz-von Schwartzenberg R, Reinhardt M, Wassermann EM, Venti CA, Votruba SB, Krakoff J. Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity. Obesity (Silver Spring). 2015 Nov;23(11):2149-56. doi: 10.1002/oby.21313.

    PubMed 26530931

  • Goldman RL, Borckardt JJ, Frohman HA, O'Neil PM, Madan A, Campbell LK, Budak A, George MS. Prefrontal cortex transcranial direct current stimulation (tDCS) temporarily reduces food cravings and increases the self-reported ability to resist food in adults with frequent food craving. Appetite. 2011 Jun;56(3):741-6. doi: 10.1016/j.appet.2011.02.013. Epub 2011 Feb 23.

    PubMed 21352881

  • Grall-Bronnec M, Sauvaget A. The use of repetitive transcranial magnetic stimulation for modulating craving and addictive behaviours: a critical literature review of efficacy, technical and methodological considerations. Neurosci Biobehav Rev. 2014 Nov;47:592-613. doi: 10.1016/j.neubiorev.2014.10.013.

    PubMed 25454360

  • Jauch-Chara K, Kistenmacher A, Herzog N, Schwarz M, Schweiger U, Oltmanns KM. Repetitive electric brain stimulation reduces food intake in humans. Am J Clin Nutr. 2014 Oct;100(4):1003-9. doi: 10.3945/ajcn.113.075481. Epub 2014 Aug 6.

    PubMed 25099550

  • Juarascio AS, Manasse SM, Espel HM, Kerrigan SG, Forman EM. Could training executive function improve treatment outcomes for eating disorders? Appetite. 2015 Jul;90:187-93. doi: 10.1016/j.appet.2015.03.013. Epub 2015 Mar 14.

    PubMed 25777264

  • Sauvaget A, Trojak B, Bulteau S, Jimenez-Murcia S, Fernandez-Aranda F, Wolz I, Menchon JM, Achab S, Vanelle JM, Grall-Bronnec M. Transcranial direct current stimulation (tDCS) in behavioral and food addiction: a systematic review of efficacy, technical, and methodological issues. Front Neurosci. 2015 Oct 9;9:349. doi: 10.3389/fnins.2015.00349. eCollection 2015.

    PubMed 26500478

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cognitive Training and transcranial Direct-Current Stimulation (tDCS) in people with Obesity, Morbid and Obesity (BMI > 35) and Diabetes Mellitus, run by Parc de Salut Mar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in food intake (time frame: 4 consecutive days during the week before starting the treatment; 4 consecutive days during the week of treatment;). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03943979, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in