Neuromodulation With Transcranial Direct Current Stimulation (tDCS) to Control Excess Weight

NCT03351426 | Completed Phase 2

• 1 other identifier: CEI/HU/2016/11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of noninvasive neuromodulation with transcranial direct current stimulation (tDCS) aimed at enhancing the excitability of the left prefrontal cortex in middle-aged women with excess body weight. This is a randomized, parallel, double-blind study with a duration of 4 weeks. Outcome measures will include changes in performance in a computerized task assessing executive functions, subjective measures of food craving and appetite and changes in body weight.

Conditions

Overweight and Obesity

Keywords

obesity; overweight; neuromodulation; transcranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

• Body weight

  Change

  Baseline, 4 weeks (end of the study)

Secondary Outcomes (2)

• Appetite (hunger)

  Baseline, 4 weeks (end of the study)

• Food craving

  Baseline, 4 weeks (end of the study)

Study Arms (2)

Active tDCS Group

ACTIVE COMPARATOR

Subjects will receive a total of eight tDCS sessions: 1st week five daily sessions (Monday to Friday), followed by 2nd week three sessions only (Monday, Wednesday, Friday). tDCS sessions will consist of 20 minutes stimulation at 2mA. Target: left dorsolateral prefrontal cortex (DLPFC). Montage: 5x5 sponge electrodes placed over EEG 10:20 system location F3 (anode) and right supraorbital area (cathode).

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS Group

SHAM COMPARATOR

Subjects will receive a total of eight tDCS sessions: 1st week five daily sessions (Monday to Friday), followed by 2nd week three sessions only (Monday, Wednesday, Friday). tDCS sessions will be sham stimulation (30-second ramp up and down). Target: left dorsolateral prefrontal cortex (DLPFC). Montage: 5x5 sponge electrodes placed over EEG 10:20 system location F3 (anode) and right supraorbital area (cathode).

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

Transcranial Direct Current Stimulation (tDCS) is a noninvasive form of neuromodulation that uses constant, low-intensity direct current delivered via electrodes that are placed on the head.

Active tDCS Group; Sham tDCS Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) between 25 and 35 kg/m2

You may not qualify if:

• Endocrinology disorder, such as diabetes mellitus or thyroid disease
• Addiction
• Neurological, psychiatric or any other major medical condition
• Hormonal therapy
• Contraindications to receive tDCS (past history of seizures or epilepsy, metallic implants on the head, skin disease or lesions in the area to be stimulated).

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Centro Médico Complutense

Alcalá de Henares, Madrid, Spain

Location

Related Publications (10)

• Val-Laillet D, Aarts E, Weber B, Ferrari M, Quaresima V, Stoeckel LE, Alonso-Alonso M, Audette M, Malbert CH, Stice E. Neuroimaging and neuromodulation approaches to study eating behavior and prevent and treat eating disorders and obesity. Neuroimage Clin. 2015 Mar 24;8:1-31. doi: 10.1016/j.nicl.2015.03.016. eCollection 2015.

  PMID: 26110109 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

• Truong DQ, Magerowski G, Blackburn GL, Bikson M, Alonso-Alonso M. Computational modeling of transcranial direct current stimulation (tDCS) in obesity: Impact of head fat and dose guidelines. Neuroimage Clin. 2013 May 31;2:759-66. doi: 10.1016/j.nicl.2013.05.011. eCollection 2013.

  PMID: 24159560 BACKGROUND

• 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

• Heinitz S, Reinhardt M, Piaggi P, Weise CM, Diaz E, Stinson EJ, Venti C, Votruba SB, Wassermann EM, Alonso-Alonso M, Krakoff J, Gluck ME. Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial. Am J Clin Nutr. 2017 Dec;106(6):1347-1357. doi: 10.3945/ajcn.117.158089. Epub 2017 Oct 18.

  PMID: 29046305 BACKGROUND

• Ljubisavljevic M, Maxood K, Bjekic J, Oommen J, Nagelkerke N. Long-Term Effects of Repeated Prefrontal Cortex Transcranial Direct Current Stimulation (tDCS) on Food Craving in Normal and Overweight Young Adults. Brain Stimul. 2016 Nov-Dec;9(6):826-833. doi: 10.1016/j.brs.2016.07.002. Epub 2016 Jul 15.

  PMID: 27498606 BACKGROUND

• Macedo IC, de Oliveira C, Vercelino R, Souza A, Laste G, Medeiros LF, Scarabelot VL, Nunes EA, Kuo J, Fregni F, Caumo W, Torres ILS. Repeated transcranial direct current stimulation reduces food craving in Wistar rats. Appetite. 2016 Aug 1;103:29-37. doi: 10.1016/j.appet.2016.03.014. Epub 2016 Mar 10.

  PMID: 26972354 BACKGROUND

• Stoeckel LE, Birch LL, Heatherton T, Mann T, Hunter C, Czajkowski S, Onken L, Berger PK, Savage CR. Psychological and neural contributions to appetite self-regulation. Obesity (Silver Spring). 2017 Mar;25 Suppl 1(Suppl 1):S17-S25. doi: 10.1002/oby.21789.

  PMID: 28229541 BACKGROUND

• Moreno S, Rodriguez S, Fernandez MC, Tamez J, Cepeda-Benito A. Clinical validation of the trait and state versions of the Food Craving Questionnaire. Assessment. 2008 Sep;15(3):375-87. doi: 10.1177/1073191107312651. Epub 2008 Feb 29.

  PMID: 18310596 BACKGROUND

• Blundell J, deGraaf K, Finlayson G, Halford JCG, Hetherington M, King N, et al., Chapter 8. Measuring food intake, hunger, satiety, and satiation in the laboratory, in: Allison DB and Baskin ML, (Eds.), Handbook of assessment methods for eating behaviors and weight-related problems: measures, theory, and researched, SAGE Publications, Inc, Thousand Oaks, CA, 2009.

  BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study is double blind. Neither the participants or the investigator delivering the intervention and collecting the outcomes will be aware of the group allocation. This is achieved via sham tDCS procedure and blinding of tDCS parameters with code system.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 22, 2017
• Study Start: September 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)