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

March 8, 2023 updated by: University of Minnesota
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive training + 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.
Other: Active tDCS
cognitive training + active-tDCS tDCS twice a day (two 13 minute sessions per day, each 2mA / 25cm² = 0.08 current density; anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for five consecutive days.
Sham Comparator: Cognitive training + 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.
Other: Sham tDCS
cognitive training + sham-tDCS tDCS twice a day (two 13 minute sessions per day, each 2mA / 25cm² = 0.08 current density; anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for five consecutive days.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30319 protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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