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Completed

NCT Number: NCT03351426

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

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.

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Key information

Conditions

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

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centro Médico Complutense

Alcalá de Henares, Madrid, Spain

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Body weight

    Time frame: Baseline, 4 weeks (end of the study)

    Change

Secondary outcomes

  1. Appetite (hunger)

    Time frame: Baseline, 4 weeks (end of the study)

    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.

  2. Food craving

    Time frame: Baseline, 4 weeks (end of the study)

    Change, evaluated via scores in the State Food Craving Questionnaire developed by Cepeda-Benito (Moreno et al 2008).

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2017
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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