Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
STIMULATECOVID
Modulation of Post-COVID-19 Fatigue Using Transcranial Direct Current Stimulation. Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
1 other identifier
interventional
47
1 country
1
Brief Summary
Fatigue is common and disabling in patients with post-COVID syndrome. There is no treatment available at this moment, and fatigue has important consequences. The main aim of this study is to evaluate the changes in the severity of fatigue using non-invasive neuromodulation in patients with post-COVID condition. This is a randomized, parallel, double-blind, placebo-controlled clinical trial using transcranial direct current stimulation. Secondary aims include changes in cognition, depression, and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Apr 2022
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedAugust 22, 2022
August 1, 2022
3 months
February 19, 2022
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Fatigue
Modified Fatigue Impact Scale (MFIS)
2 weeks
Secondary Outcomes (3)
Change in cognition
2 weeks
Change in depressive symptoms
2 weeks
Change in quality of life
2 weeks
Study Arms (2)
Active tDCS
ACTIVE COMPARATORTranscranial current direct stimulation. 8 days.
Sham tDCS
SHAM COMPARATORSham transcranial current direct stimulation. 8 days.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COVID-19 with PCR-confirmation.
- Fatigue linked to COVID-19
- No diagnosis of neurological, psychiatric or medical disorder with potential impact on fatigue.
You may not qualify if:
- Stroke before COVID-19
- History of traumatic brain lesion or central nervous system infection previous to COVID-19
- Radiotherapy or chemotherapy for cancer
- Severe sensorial deficits
- Drugs or uncontrolled medical disorder with potential impact on fatigue.
- History of abuse of alcohol or other toxics.
- Any contraindication for tDCS (metallic implants, brain devices, pacemakers, head injuries).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico San Carlos.
Madrid, 28040, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD MD
Study Record Dates
First Submitted
February 19, 2022
First Posted
February 23, 2022
Study Start
April 1, 2022
Primary Completion
June 26, 2022
Study Completion
July 31, 2022
Last Updated
August 22, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share