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Overweight and ObesityPhase 2NCT03351426

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

A Phase 2 study testing Transcranial Direct Current Stimulation (tDCS) in people with Overweight and Obesity, run by University of Alcala at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Transcranial Direct Current Stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSpain
Study dates
1 Sep 2016to May 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Centro Médico Complutense

    Alcalá de Henares, Madrid

Other trials in Spain

About this study

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.

Read the 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.
Being tested
Transcranial Direct Current Stimulation (tDCS)
Keywords
obesity, overweight, neuromodulation, transcranial direct current stimulation (tDCS)
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03351426
Study groupRoleWhat they receive
Active tDCS GroupActive comparatorSubjects 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).
Receives: Device: Transcranial Direct Current Stimulation (tDCS)
Sham tDCS GroupSham comparatorSubjects 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).
Receives: Device: Transcranial Direct Current Stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    Change

    Measured: Baseline, 4 weeks (end of the study)

Secondary outcomes (2)

  1. 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.

    Measured: Baseline, 4 weeks (end of the study)

  2. Food craving

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

    Measured: Baseline, 4 weeks (end of the study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start1 Sep 2016
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03351426
Sponsor's protocol ID
CEI/HU/2016/11
Status last verified
Aug 2018
First submitted
15 Nov 2017
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26110109

  • 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.

    PubMed 26530931

  • 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.

    PubMed 24159560

  • 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.

    PubMed 23986687

  • 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.

    PubMed 29046305

  • 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.

    PubMed 27498606

  • 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.

    PubMed 26972354

  • 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.

    PubMed 28229541

  • 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.

    PubMed 18310596

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transcranial Direct Current Stimulation (tDCS) in people with Overweight and Obesity, run by University of Alcala at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: Baseline, 4 weeks (end of the study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03351426, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.

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