Trial Outcomes & Findings for RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms (NCT NCT05965752)

NCT ID: NCT05965752

Last Updated: 2025-07-18

Results Overview

Appendix-specific outcome measure data will be reported under the associated NCT ID.

Recruitment status

COMPLETED

Study phase

Target enrollment

328 participants

Primary outcome timeframe

160 Days

Results posted on

2025-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	BrainHQ Active Comparator 5 sessions/week at 30 min/session BrainHQ/Active Comparator Activity: 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 5 sessions/week at 30 min/session BrainHQ: 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.	BrainHQ + PASC CoRE BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 30 min/session BrainHQ: 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: 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.	Brain HQ + tDCS-active 2.0 mA stimulation delivered for 30 min during each BrainHQ session BrainHQ: 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. tDCS-active: 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.	Brain HQ + tDCS-sham Inactive stimulation delivered for 30 min during each BrainHQ session BrainHQ: 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. tDCS-sham: 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.
Overall Study STARTED	64	67	66	66	65
Overall Study COMPLETED	59	62	62	55	58
Overall Study NOT COMPLETED	5	5	4	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	BrainHQ Active Comparator 5 sessions/week at 30 min/session BrainHQ/Active Comparator Activity: 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 5 sessions/week at 30 min/session BrainHQ: 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.	BrainHQ + PASC CoRE BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 30 min/session BrainHQ: 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: 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.	Brain HQ + tDCS-active 2.0 mA stimulation delivered for 30 min during each BrainHQ session BrainHQ: 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. tDCS-active: 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.	Brain HQ + tDCS-sham Inactive stimulation delivered for 30 min during each BrainHQ session BrainHQ: 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. tDCS-sham: 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.
Overall Study Adverse Event	0	1	0	1	3
Overall Study Lost to Follow-up	2	0	1	1	1
Overall Study Withdrawal by Subject	2	2	1	5	0
Overall Study Disease Relapse	1	0	1	0	0
Overall Study Failure to Meet Randomization Criteria	0	1	0	1	0
Overall Study Unable to Return for Study Visits	0	1	0	3	1
Overall Study Early Termination	0	0	1	0	0
Overall Study Reported Unwanted Symptoms	0	0	0	0	1
Overall Study Did Not Want to be Randomized to Intervention	0	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BrainHQ Active Comparator n=64 Participants 5 sessions/week at 30 min/session BrainHQ/Active Comparator Activity: 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 n=67 Participants 5 sessions/week at 30 min/session BrainHQ: 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.	BrainHQ + PASC CoRE n=66 Participants BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 30 min/session BrainHQ: 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: 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.	Brain HQ + tDCS-active n=66 Participants 2.0 mA stimulation delivered for 30 min during each BrainHQ session BrainHQ: 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. tDCS-active: 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.	Brain HQ + tDCS-sham n=65 Participants Inactive stimulation delivered for 30 min during each BrainHQ session BrainHQ: 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. tDCS-sham: 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.	Total n=328 Participants Total of all reporting groups
Age, Continuous	44.5 years n=5 Participants	49.0 years n=7 Participants	53.0 years n=5 Participants	47.0 years n=4 Participants	49.0 years n=21 Participants	48.0 years n=10 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	49 Participants n=7 Participants	49 Participants n=5 Participants	46 Participants n=4 Participants	45 Participants n=21 Participants	241 Participants n=10 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	20 Participants n=4 Participants	20 Participants n=21 Participants	87 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	14 Participants n=21 Participants	52 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	55 Participants n=7 Participants	56 Participants n=5 Participants	55 Participants n=4 Participants	51 Participants n=21 Participants	274 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	15 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	12 Participants n=21 Participants	47 Participants n=10 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	46 Participants n=7 Participants	49 Participants n=5 Participants	50 Participants n=4 Participants	43 Participants n=21 Participants	235 Participants n=10 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	15 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	11 Participants n=10 Participants
Region of Enrollment United States	64 Participants n=5 Participants	67 Participants n=7 Participants	66 Participants n=5 Participants	66 Participants n=4 Participants	65 Participants n=21 Participants	328 Participants n=10 Participants

PRIMARY outcome

Timeframe: 160 Days

Population: Enrolled participants.

Appendix-specific outcome measure data will be reported under the associated NCT ID.