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

University of Alcala

Status and phase: Completed; Phase 2

Conditions: Overweight and Obesity

Treatments: Device: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03351426

CEI/HU/2016/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Active tDCS Group

Active Comparator group

Description:

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).

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS Group

Sham Comparator group

Description:

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).

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)