RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms

Conditions

• Long COVID
• Long COVID-19
• Long COVID19

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BrainHQ/Active Comparator Activity — OTHER
  BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
• BrainHQ — OTHER
  BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
• PASC CoRE — OTHER
  PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
• tDCS-active — DEVICE
  Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place. The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
• tDCS-sham — DEVICE
  tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.

Study Details

This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains.

Key Dates

Start date

Sep 1, 2023

Status verified

Jul 2025

Primary completion

Jun 10, 2024

Completion

Jun 10, 2024

Study Design

Enrollment

328 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: BrainHQ Active Comparator
  5 sessions/week at 30 min/session
• Experimental: BrainHQ
  5 sessions/week at 30 min/session
• Experimental: BrainHQ + PASC CoRE
  BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 30 min/session
• Experimental: Brain HQ + tDCS-active
  2.0 mA stimulation delivered for 30 min during each BrainHQ session
• Placebo Comparator: Brain HQ + tDCS-sham
  Inactive stimulation delivered for 30 min during each BrainHQ session

Primary Outcome Measure

Total Number of Participants Enrolled in Each Appendix [ Time Frame: 160 Days ]

Locations (24)

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