Cognitive Rehabilitation for People With Cognitive Covid19

NCT ID: NCT05731570

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2024-09-30

Brief Summary

Cognitive impairment is increasingly recognised as a major component of long Covid, and is estimated to be present in 25-75% of affected individuals. This impairment impacts quality of life and the loss of functional ability has major consequences for affected people, their families and the wider economy given people's difficulty in returning to work.

This study will focus on helping people recover from cognitive Covid. This will involve use of rehabilitation strategies aimed at improving function in those cognitive functions identified in Stage 1 as being most affected, and assessing the benefit of rehabilitation on quality of life and people's ability to return to everyday function. These strategies will be co-produced in collaboration with a group of people living with cognitive Covid. At the end of Stage 2 we will produce a freely available "Covid-19 Cognitive Recovery Guide" for affected people, their close contacts and clinicians.

In conclusion, cognitive impairment is frequently observed in long Covid but at present little is understood about its nature, or how it can be treated. The sheer scale of the CV19 pandemic makes this a top priority unmet need for healthcare worldwide. The aim of this study is to meet this need and to deliver a treatment plan for affected people which will help them return to normal life and working ability.

Conditions

Long Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

cognitive rehabilitation programme. 1h session per week x 10 weeks

Group Type: EXPERIMENTAL

Cognitive rehabilitation

Intervention Type: BEHAVIORAL

Set of restorative and compensatory strategies to rehabilitate cognitive function combined with emotional regulation techniques.

Control

The control group receives treatment as usual, this is, participants will carry on with the care they were receiving prior to entry in the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive rehabilitation

Set of restorative and compensatory strategies to rehabilitate cognitive function combined with emotional regulation techniques.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Aged between 30 and 60 years

2. Evidence of prior CV19 infection:

• either positive CV19 PCR
• or positive CV19 antibody test
• or acute symptoms consistent with the recognised core features of acute CV19 infection and post-acute symptoms consistent with the recognised core features of long Covid

3. Cognitive impairment persisting more than three months after the acute CV19 infection, defined in terms of subjective reports of cognitive decline post-infection

Exclusion Criteria

1. Cognitive impairment prior to CV19 infection

2. Occurrence of acute neurological disorder, such as stroke or encephalitis, that could give rise to cognitive sequelae

3. People who are on any medications that are considered by the study investigators to have significant adverse effects on cognition

4. A pre-existing major psychiatric or medical disorder that is considered by the study investigators to have potential to affect cognition

5. High alcohol intake

6. Recreational drug use

7. Loss of mental capacity such that the affected individual is unable to give informed consent

8. Participants will not be eligible for Workstream 2 if they do not exhibit significant impairment on baseline cognitive assessments, as they will not gain from cognitive rehabilitation.

9. Participants with pacemakers or other implanted devices, those with metal foreign bodies (e.g. shrapnel from war injuries) and those who have had certain types of surgery will be excluded from the MRI substudy. Although MRI is not known to affect the unborn child, we will also exclude subjects who may be pregnant just to be on the safe side.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangor University

OTHER

Sponsor Role: collaborator

St George's University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Brighton

OTHER

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Greater Manchester Mental Health NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Chan, Dr

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

University College London

London, , United Kingdom

Countries

United Kingdom

References

Vanova M, Patel AMR, Scott I, Gilpin G, Manning EN, Ash C, Wittenberg P, Lim J, Hoare Z, Evans R, Bray N, Kipps CM, Devine C, Ahmed S, Dunne R, Koniotes A, Warren C, Chan D, Suarez-Gonzalez A. Telehealth-delivered cognitive rehabilitation for people with cognitive impairment as part of the post-COVID syndrome: protocol for a randomised controlled trial as part of the CICERO (Cognitive Impairment in Long COVID: Phenotyping and Rehabilitation) study. Trials. 2024 Oct 22;25(1):704. doi: 10.1186/s13063-024-08554-3.

Reference Type: DERIVED

PMID: 39434179 (View on PubMed)

Other Identifiers

CICERO clinical trial

Identifier Type: -

Identifier Source: org_study_id