Neuromodulation in COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This clinical study is aimed at investigating the effects of transcranial direct current
      stimulation (tDCS) on COVID-19 patients not admitted to the intensive care unit. The tDCS is
      a non-invasive brain stimulation technique which applies a low intensity electrical current
      in order to modulate neuronal activity. Patients included will be submitted to a single
      session with active or sham tDCS, aiming to modulate prefrontal or supplementary motor area
      (SMA). Evaluation protocol will be performed before and after stimulation to verify the
      incidence of adverse events related to treatment and whether tDCS would affect measures of
      executive functioning, mood, anxiety, autonomic response and motor function in COVID-19
      patients. We hypothesize the neuromodulation would be a safety, promising treatment to reduce
      possible impairments in COVID-19 patients.
    


Intervention name(s): Transcranial direct-current stimulation; Transcranial direct-current stimulation; Sham Transcranial direct-current stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): A single tDCS session will be delivered to the supplementary motor area (SMA) by a DC stimulator (NeuroConn, Germany). During stimulation, a pair of saline-soaked sponge electrodes (surface 35 cm²) will be used, with one electrode (anode) placed 1,8 cm forward Cz and the other electrode (cathode) over the right supraorbital region, according to the International 10-20 EEG system. Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 minutes current intensity will be ramp down for 30 seconds.; A single tDCS session will be applied bilaterally over the dorsolateral prefrontal cortex (DLPFC) by a DC stimulator (NeuroConn, Germany). During stimulation, a pair of saline-soaked sponge electrodes (surface 35 cm²) will be placed over F3 (anode) and F4 (cathode), according to the International 10-20 EEG system. Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 minutes current intensity will be ramp down for 30 seconds.; A single Sham-tDCS session will be applied bilaterally over the dorsolateral prefrontal cortex (DLPFC) or over the supplementary motor area (SMA) by a DC stimulator (NeuroConn, Germany). A pair of saline-soaked sponge electrodes (surface 35 cm²) will be placed according to the International 10-20 EEG system. For SMA , one electrode (anode) will be placed 1,8 cm forward Cz and the other electrode (cathode) over the right supraorbital region. For DLPFC, electrodes will be placed over F3 (anode) and F4 (cathode). Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 seconds current intensity will be ramp down for 15 seconds.
Other intervention name(s): Active Transcranial direct-current stimulation; tDCS; Active Transcranial direct-current stimulation; tDCS; Sham TDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV-2; transcranial direct current stimulation (tDCS); executive function; depression; anxiety; autonomic nervous system; motor function