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

NCT03943979 | Completed Phase 2

• 1 other identifier: IMIMFTLC/EC-TDCS OM
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (12)

• Change in electroencephalogram (EEG) power and coherence

  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)

  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.

  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

  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)

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

Study Arms (2)

Active Control group

SHAM COMPARATOR

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

Other: Cognitive Training

Active group

ACTIVE COMPARATOR

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

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

Interventions

Cognitive Training OTHER

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 Control group; Active group

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).

Active group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Neuroelectrics Corporation: collaborator

Related Publications (12)

• 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.

  PMID: 23986687 BACKGROUND

• 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.

  PMID: 19630729 BACKGROUND

• 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.

  PMID: 26066577 BACKGROUND

• 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.

  PMID: 24776374 BACKGROUND

• 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.

  PMID: 26543007 BACKGROUND

• 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.

  PMID: 22532165 BACKGROUND

• 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.

  PMID: 26530931 BACKGROUND

• 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.

  PMID: 21352881 BACKGROUND

• 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.

  PMID: 25454360 BACKGROUND

• 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.

  PMID: 25099550 BACKGROUND

• 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.

  PMID: 25777264 BACKGROUND

• 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.

  PMID: 26500478 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Diabetes Mellitus; Hypertension

Interventions

Cognitive Training; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: May 9, 2019
• Study Start: February 25, 2016
• Primary Completion: May 26, 2017
• Study Completion: June 1, 2017
• Last Updated: May 9, 2019

Record last verified: 2019-05