TDCS-potentiated Generalization of Cognitive Training in the Rehabilitation of Long COVID Symptoms

Not Applicable

Withdrawn

• Conditions: Post-acute Sequelae SARS-CoV-2 Infection (PASC)
• Interventions: Other: Active tDCS; Other: Sham tDCS

• Registration Number: NCT05589272
• Lead Sponsor: University of Minnesota

Brief Summary

The overarching goals of this study are to employ cognitive testing to understand how transcranial direct current stimulation (tDCS), when used concurrently with cognitive training tasks, can affect cognitive impairment symptoms in individuals with long COVID, or post-acute sequelae SARS-CoV-2 infection (PASC), and to examine variability in response between active and sham tDCS treatment groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-21
• Study Start: 2023-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-13
• Primary Completion: 2023-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Ability to provide consent and comply with study procedures
• Age 18 to 60 years old
• Estimated IQ within the specified range (70 <= IQ E <= 115)
• Current post-acute sequelae SARS-CoV-2 infection (PASC) as defined by the National Center for Health Statistics post-COVID-19 conditions survey ((Long COVID 2022), including impaired cognition symptoms, for at least 3 months post-infection
• Ability to participate in four weekly 40' training sessions over four weeks and participate in two assessments
• English speaking

Exclusion Criteria

• Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness >30 min, concussion involving hospital admission, HIV)
• Contraindications for tDCS (e.g. history of seizures)
• Five or more sessions of neuromodulation (such as tDCS) or cognitive training in the past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive training + active-tDCS	Active tDCS	Cognitive training + active-tDCS 4 times per week (20 minutes per session, each (\~25cm²; current density = 0.08 mA/cm²); anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for four weeks.
Cognitive training + sham-tDCS	Sham tDCS	Cognitive training + sham-tDCS 4 times per week (20 minutes per session, each \~25cm²; current density = 0.08 mA/cm²); anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for four weeks.

Primary Outcome Measures

Name	Time	Method
Cognitive improvement effects of WM training with active tDCS vs. sham	baseline and post-test assessment, 4 weeks	shown by WM task progression and performance on cognitive testing measures
Generalization of cognitive effects of active tDCS vs. sham	baseline and post-test assessment, 4 weeks	includes effect on PASC-related cognitive impairment symptoms

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States