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Does Combined Non-Invasive Neuromodulation affect cerebral oxygenation and the sympathetic/parasympathetic system in subjects with Depression? Controlled and randomized study

Does Combined Non-Invasive Neuromodulation affect intracranial hemodynamics and sympathetic/parasympathetic neurovegetative tone in subjects with Depressive Disorder? Controlled and randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-42xvqrz
Enrollment
Unknown
Registered
2024-06-12
Start date
2024-06-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

The sample will consist of 63 participants divided into 3 groups in a 1:1:1 ratio, as follows: Group 1 (taVNS): 21 participants subjected to transcutaneous auricular vagus nerve stimulation, BDI-II in
Group 2 (tDCS): 21 participants subjected to transcranial direct current stimulation, BDI-II inventory, galvanic skin response, and SatO2 evaluation
Group 3 (taVNS+tDCS): 21 participants subjected to transcutaneous auricular vagus nerve stimulation, transcranial direct current stimulation, BDI-II inventory, galvanic skin response, and SatO2 evalua
E02.331.800
E02.331.750

Sponsors

Universidade Federal de Juiz de Fora
Lead Sponsor
Universidade Federal de Juiz de Fora
Collaborator

Eligibility

Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Participants with mild and moderate depressive disorder; aged between 18 and 45 years; diagnosed and reported by a professional psychiatrist and/or psychologist

Exclusion criteria

Exclusion criteria: Individuals with epilepsy using anticonvulsant medication and/or sleep deprivation; participants with metallic materials implanted in or near the head; participants with cardiac pacemakers or wires (Stents) or with another active device in which the interaction with the electric field may interfere with its functioning; participants with eczema on the head

Design outcomes

Primary

MeasureTime frame
It is expected that, through non-invasive neuromodulation protocols, there will be an improvement in depressive symptoms assessed by the BDI-II in the short and long term, and also a gradual decrease in the galvanic response of the skin, as well as an increase in intracranial SatO2, both immediately to the application of the stimuli, and in the long term, with the best responses expected with the combined intervention protocol (taVNS+tDCS group) compared to the others—

Secondary

MeasureTime frame
Permanence of positive results in depressive symptoms, galvanic response skin and intracranial SatO2 after 3, 6 and 12 months of follow-up—

Countries

Brazil

Contacts

Public ContactAlexndre Barbosa

Universidade Federal de Juiz de Fora

alexandre.barbosa@ufjf.br+55 (33) 99154-1851

Outcome results

None listed

Source: REBEC (via WHO ICTRP)