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Behavioural Intervention
Cognitive Rehabilitation for Long COVID
N/A
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, eoi (day 70), eos (day 160)
Awards & highlights
Study Summary
This trial seeks to evaluate interventions to improve cognitive symptoms caused by PASC. It includes a commercially available program (BrainHQ) plus potential other interventions that could improve cognition.
Who is the study for?
This trial is for individuals with Long COVID who experience cognitive issues like trouble with thinking or attention. Participants must meet the broader RECOVER-NEURO protocol criteria and cannot have metal objects in their head/neck, skin conditions near tDCS stimulation sites, or any other risks as determined by the investigator.Check my eligibility
What is being tested?
The study tests BrainHQ exercises alone, combined with PASC CoRE (a cognitive rehabilitation program), or paired with active/sham tDCS (transcranial direct current stimulation) to see if they improve cognition in Long COVID patients compared to standard activities.See study design
What are the potential side effects?
Potential side effects may include discomfort at the electrode site from tDCS, mild headaches, itching under electrode pads during stimulation, and fatigue. Side effects are generally minimal for BrainHQ exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, eoi (day 70), eos (day 160)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, eoi (day 70), eos (day 160)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in Everyday Cognition 2 (ECog2)
Change in PROMIS-cognitive function - short form 8a (PROMIS-Cog) total score
Change on an objective neurocognitive battery scores
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: BrainHQ + PASC CoREExperimental Treatment2 Interventions
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
Group II: BrainHQExperimental Treatment1 Intervention
5 sessions/week at 30 min/session
Group III: Brain HQ + tDCS-activeExperimental Treatment2 Interventions
2.0 mA stimulation delivered for 30 min during each BrainHQ session
Group IV: BrainHQ Active ComparatorActive Control1 Intervention
5 sessions/week at 30 min/session
Group V: Brain HQ + tDCS-shamPlacebo Group2 Interventions
Inactive stimulation delivered for 30 min during each BrainHQ session
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,419,907 Total Patients Enrolled
Daniel Laskowitz, MD MHSStudy ChairDuke University
1 Previous Clinical Trials
315 Total Patients Enrolled
Kanecia Zimmerman, MD PhDStudy ChairDuke University
2 Previous Clinical Trials
1,215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have metal objects in your head or neck.
Research Study Groups:
This trial has the following groups:- Group 1: Brain HQ + tDCS-sham
- Group 2: BrainHQ
- Group 3: BrainHQ + PASC CoRE
- Group 4: Brain HQ + tDCS-active
- Group 5: BrainHQ Active Comparator
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this trial currently open?
"The clinicaltrials.gov page for this trial states that it is no longer actively recruiting patients, having been first posted on August 1st 2023 and last updated the same day. However, there are currently 581 other research studies which require volunteers."
Answered by AI
Who else is applying?
What site did they apply to?
All sites listed under NCT05965752
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
It's been a little over a year since I had COVID-19 (confirmed PCR). Since then, I have been suffering from multiple issues including brain fog, headaches, dizziness, sleep difficulties, anxiety and depression.
PatientReceived 1 prior treatment
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