CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Cognitive Training +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03943979
NCT03943979Phase 2Completed

Pilot Study of an Intervention Involving Cognitive Training and Transcranial Direct-current Stimulation (tDCS) in Morbidly Obese Subjects

Parc de Salut Mar·interventional·Posted May 9, 2019·Updated May 9, 2019

In Brief

A Phase 2 clinical trial evaluating Cognitive Training and transcranial Direct-Current Stimulation (tDCS) for Obesity, Morbid and 3 related conditions. Completed, enrolled 18 participants.

Detailed Summary

The study aims to: 1) investigate the effects of cognitive training (CT) and combined CT and transcranial direct current stimulation (tDCS) on food intake and 2) to further understand its neuropsychological and neurophysiological basis (i.e. EEG) as well as its impact in endocannabinoids (EC) in a sample of morbidly obese patients seeking for a gastric bypass surgery

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 9, 2019
Enrollment StartFeb 25, 2016
Primary CompletionMay 26, 2017
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.1 years ago

Interventions

Cognitive Trainingother

Cognitive Training (CT): 4 consecutive days, 30-45 min session involving 5 different tasks designed to train executive functions and attention, available at the Guttmann Neuropersonaltrainer platform (computerized cognitive training tool certified by the Spanish Agency for Medicines and Health Products as a Class I Health Product). The difficulty level of all the tasks was automatically adjusted on a trial-by-trial basis for both Active and Active Control conditions.

transcranial Direct-Current Stimulation (tDCS)device

tDCS: 4 consecutive days, 20 min session, delivered through multichannel tDCS (Starstim, Neuroelectrics), with an excitatory target over the r-dlPFC, and an inhibitory target on the contralateral lobe (l-dlPFC). The positioning of the multichannel tCS (electrode location and currents) was solved using the Stimweaver (Ruffini 2013). The resulting tCS montage employed 8 gelled Ag/AgCl electrodes of π cm2 size (Pistim, Neuroelectrics) placed at AF3(-1093uA), AF4 (1178uA), F3 (-1161uA), F4 (1104uA), F7 (-414uA), F8 (530uA), FC5 (1189uA), FC6 (-1332uA).