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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351426
• Other study ID #: CEI/HU/2016/11
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2016
• Est. completion date: May 2018

Study information

• Verified date: August 2018
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A total of 40 subjects with overweight or class I obesity will be enrolled and randomized into either Group 1) Active tDCS or Group 2) Sham (control) tDCS. The duration of the study will be 4 weeks. During the first two weeks participants will receive eight sessions of tDCS. At week 2 they will also start a hypocaloric diet. The stimulation sessions (duration: 20 minutes, intensity: 2 mA) will be applied once daily (5 days in a row) during the first week and 3 alternate days (Monday, Wednesday and Friday) during the second week. At week 2 and until the end of the study subjects will also start a hypocaloric diet.

The study aims are:

1. To examine whether anodal tDCS applied over the left prefrontal cortex can improve executive functions/inhibitory control and reduce subjective ratings of food craving and appetite.

2. To study whether anodal tDCS applied over the left prefrontal cortex, in combination with a hypocaloric diet, can facilitate weight reduction and maintenance over time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Device:
• Transcranial Direct Current Stimulation (tDCS)
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.

Locations

Country	Name	City	State
Spain	Centro Médico Complutense	Alcalá De Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Moreno S, Rodríguez 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. — View Citation

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:S17-S25. doi: 10.1002/oby.21789. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Change	Baseline, 4 weeks (end of the study)
Secondary	Appetite (hunger)	Change, evaluated via visual analogue scale (VAS). Self-reported scores to the question "How hungry are you?" representing the current state of the participant will be assessed with a horizontal line, 100 mm in length, anchored by the word descriptors "Not at all" and "Extremely", following standard methods, based on Blundell et al 2009.	Baseline, 4 weeks (end of the study)
Secondary	Food craving	Change, evaluated via scores in the State Food Craving Questionnaire developed by Cepeda-Benito (Moreno et al 2008).	Baseline, 4 weeks (end of the study)