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

NCT05589272 | Withdrawn DMC

• 1 other identifier: 30319 protocol
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Cognitive improvement effects of WM training with active tDCS vs. sham

  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

  includes effect on PASC-related cognitive impairment symptoms

  baseline and post-test assessment, 4 weeks

Study Arms (2)

Cognitive training + active-tDCS

EXPERIMENTAL

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 + sham-tDCS

SHAM COMPARATOR

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

Interventions

Active tDCS OTHER

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.

Cognitive training + active-tDCS

Sham tDCS OTHER

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.

Cognitive training + sham-tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 21, 2022
• Study Start: February 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)