Clinical trial NCT03351426: Neuromodulation With Transcranial Direct Current Stimulation (tDCS) to Control Excess Weight
Official title: Neuromodulation With Transcranial Direct Current Stimulation (tDCS) to Control Excess Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight and Obesity
Keywords: obesity
overweight
neuromodulation
transcranial direct current stimulation (tDCS)
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Body weight
timeFrame: Baseline, 4 weeks (end of the study)
Secondary outcomes:
measure: Appetite (hunger)
timeFrame: Baseline, 4 weeks (end of the study)
measure: Food craving
timeFrame: Baseline, 4 weeks (end of the study)
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Centro Médico Complutense
state: Madrid
Study officials:
References:
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