Treatment of COVID-19 Post-acute Cognitive Impairment Sequelae With tDCS

Summary

After almost 2 years of pandemic, the consequences of the post-COVID syndrome, or PASC (Post Acute-Sequelae of Sars-CoV-2), have become a major challenge in the management of affected patients, generating costs for health services. and insecurity regarding treatments for the sequelae, given the complex and still poorly understood pathophysiology of COVID-19.

This troubling scenario raises important questions about the impact of COVID-19 on central nervous system sequelae, including the risk of cognitive decline in old age and progression to dementia. Therefore, studies that propose the possibility of treatment for this new clinical condition and that are free from systemic side effects, such as transcranial direct current stimulation (tDCS) and cognitive treatment, are extremely important in the face of this scenario. In addition, the evaluation of the neural mechanisms underlying the cognitive alterations of the PASC syndrome and after the treatment using multimodal magnetic resonance imaging (MRI) becomes relevant in view of the lack of studies related to the topic.

Therefore, the objective of this double-blind randomized clinical trial is to assess whether tDCS associated with cognitive training can improve symptoms in patients with persistent cognitive deficits that started between 1 and 6 months after the resolution of acute COVID-19 infection (PASC) compared to the sham (placebo) group, in addition to exploring the structural, microstructural, functional and modeled electric field changes associated with cognitive alterations due to PASC syndrome and tDCS combined with cognitive treatment. 60 patients aged between 18 and 70 years and with a positive diagnosis of mild to moderate COVID-19 in the last 6 months in relation to the time of entry into the study will be recruited. All of them will be pre-screened online and in person to confirm the cognitive dysfunction associated with PASC.

Conditions

• Cognitive Impairment
• Post-Acute Sequelae of SARS-CoV-2 Infection
• COVID-19

Interventions

PROCEDURE

Active tDCS and cognitive training

Electrical stimulation is delivered by the Soterix device, consisting of a one-size-fits-all, transcranial direct current stimulation headset with square electrodes. The anode is positioned over the left prefrontal cortex, and the cathode over the right prefrontal cortex. Current strenght is set at 2mA for 20 minutes, daily for 5 continuous days (with a 2-day pause) for 4 weeks. Cognitive training consists of a series of tasks performed in the BrainHQ app, which aim to stimulate the impaired cognitive domains in people with PASC. The cognitive training sessions are performed concomitantly to the tDCS sessions.

PROCEDURE

Sham tDCS and cognitive training

Sham electrical stimulation is delivered by the Soterix device, consisting of a one-size-fits-all, transcranial direct current stimulation headset with square electrodes. The anode is positioned over the left prefrontal cortex, and the cathode over the right prefrontal cortex. The sham protocol consists of a fade-in and fade-out phases of 1mA for 45 seconds, followed by a silent period in between for the remaining session time. Cognitive training consists of a series of tasks performed in the BrainHQ app, which aim to stimulate the impaired cognitive domains in people with PASC. The cognitive training sessions are performed concomitantly to the tDCS sessions.

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• University of Sao Paulo

  lead OTHER

Principal Investigators

• André R Brunoni, MD, PhD · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2022-11-30

Completion

2023-03-30

Countries

• Brazil

Study Locations