Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)

Post-Acute Sequelae of COVID-19 Clinical Trial

Official title:

Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Cognitive Post-acute Sequelae of COVID-19 (PASC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092516
• Other study ID #: 2021P002953
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Hamdi Eryilmaz, Ph.D.
• Phone: 6176437462
• Email: hamdi.eryilmaz[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ability to provide informed consent

• A diagnosis of PASC as indicated by past COVID-19 infection, and persistent symptoms, including 'brain fog', confusion, short-term memory deficits, trouble concentrating, delirium, difficulties in multitasking.

Exclusion Criteria:

• History of epilepsy

• Metallic implants in the head and neck,

• Brain stimulators

• Pacemakers

• Pregnancy

• Active substance dependence (except for tobacco)

• Premorbid major neurological illness

• Severe mental illness (e.g., bipolar disorder, schizophrenia)

• Attention Deficit Hyperactivity Disorder

Related Conditions & MeSH terms

• COVID-19
• Dysexecutive Syndrome

Intervention

Device:
• Active tDCS
2 mA of anodal stimulation will be applied to the left prefrontal cortex over the F3 electrode based on the International 10-10 EEG system.
• Sham tDCS
Sham stimulation will be applied to the left prefrontal cortex over the F3 electrode.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inhibitory control	Performance during the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention.	8 weeks
Primary	Change in processing speed	Reaction time during the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention.	8 weeks
Primary	Change in EEG P300 event-related potential	EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention.	8 weeks