Neuromodulation in COVID-19 Patients

D'Or Institute for Research and Education

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Device: Transcranial direct-current stimulation; Device: Sham Transcranial direct-current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04808284

PRJ2007

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• suspected or confirmed diagnosis for SARS-CoV-2;
• ability to understand and execute the proposed protocol;
• vital signs (body temperature <38ºC, blood pressure between 90 x 60mmHg and 140 x 90 mmHg, respiratory rate between 12 e 30 bpm).

Exclusion criteria

• dyspnea or signs of respiratory effort;
• SpO2 ≤ 90%;
• hemodynamic instability;
• deep vein thrombosis, active bleeding, use of cardiac pacemaker;
• injury, pain or metallic implants in the cranium or scalp;
• seizure history;
• suspected or confirmed pregnancy;
• concomitant or previous rheumatic or neurological diseases;
• severe psychiatric diseases (schizophrenia, bipolar disorder, intellectual disability);
• severe musculoskeletal and/or integumentary disorders;
• severe psychiatric disorders;
• severe liver or kidney disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 3 patient groups

tDCS-SMA

Experimental group

Description:

Participants randomized to this arm will receive a single tDCS session delivered at 2mA to the supplementary motor area (SMA) for 30 minutes.

Treatment:

Device: Transcranial direct-current stimulation

Device: Transcranial direct-current stimulation

tDCS- DLPFC

Experimental group

Description:

Participants randomized to this arm will receive a single tDCS session delivered at 2mA to the right (cathodal) and left (anodal) dorsolateral prefrontal cortex (DLPFC) for 30 minutes.

Treatment:

Device: Transcranial direct-current stimulation

Device: Transcranial direct-current stimulation

tDCS- SHAM

Sham Comparator group

Description:

Participants randomized to this arm will receive a single session of Sham tDCS for 30 minutes, delivered to supplementary motor area (SMA) or to the right (cathodal) and left (anodal) dorsolateral prefrontal cortex (DLPFC).

Treatment:

Device: Sham Transcranial direct-current stimulation