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

Primary Purpose

Post-acute Sequelae SARS-CoV-2 Infection (PASC)

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-acute Sequelae SARS-CoV-2 Infection (PASC)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cognitive training + active-tDCS

Cognitive training + sham-tDCS

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Cognitive improvement effects of WM training with active tDCS vs. sham
shown by WM task progression and performance on cognitive testing measures
Generalization of cognitive effects of active tDCS vs. sham
includes effect on PASC-related cognitive impairment symptoms

Secondary Outcome Measures

Full Information

First Posted
October 19, 2022
Last Updated
March 8, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05589272
Brief Title
TDCS-potentiated Generalization of Cognitive Training in the Rehabilitation of Long COVID Symptoms
Official Title
TDCS-potentiated Generalization of Cognitive Training in the Rehabilitation of Long COVID Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Didn't receive IRB approval
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-acute Sequelae SARS-CoV-2 Infection (PASC)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive training + active-tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive training + sham-tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active tDCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive improvement effects of WM training with active tDCS vs. sham
Description
shown by WM task progression and performance on cognitive testing measures
Time Frame
baseline and post-test assessment, 4 weeks
Title
Generalization of cognitive effects of active tDCS vs. sham
Description
includes effect on PASC-related cognitive impairment symptoms
Time Frame
baseline and post-test assessment, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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