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

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ClinicalTrials.gov Identifier: NCT03351426
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Pedro de la Villa Polo, University of Alcala

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Device: Transcranial Direct Current Stimulation (tDCS) Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Neuromodulation With Transcranial Direct Current Stimulation (tDCS) to Control Excess Weight
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Active tDCS Group
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)
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.

Sham Comparator: Sham tDCS Group
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)
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 Outcome Measures :
  1. Body weight [ Time Frame: Baseline, 4 weeks (end of the study) ]
    Change


Secondary Outcome Measures :
  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).



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351426


Locations
Spain
Centro Médico Complutense
Alcalá De Henares, Madrid, Spain
Sponsors and Collaborators
University of Alcala

Publications:
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.

Responsible Party: Pedro de la Villa Polo, Professor, University of Alcala
ClinicalTrials.gov Identifier: NCT03351426     History of Changes
Other Study ID Numbers: CEI/HU/2016/11
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pedro de la Villa Polo, University of Alcala:
obesity
overweight
neuromodulation
transcranial direct current stimulation (tDCS)

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms