Transcranial Direct Stimulation for Persistent Fatigue Tr... | NCT05252481

Studies
Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19

NCT05252481

Sponsor

Hospital San Carlos, Madrid

Status

Completed

Last Update Posted

Aug 22, 2022Actual

Enrollment

47Actual

Phase

Not Applicable

Conditions

COVID-19

Interventions

Active tDCS
Sham tDCS

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Jun 26, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Feb 19, 2022

First Submission Date that Met QC Criteria

Feb 21, 2022

First Posted Date

Feb 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2022

Last Update Posted Date

Aug 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active tDCS	Active Comparator	Transcranial current direct stimulation. 8 days.	Device: Active tDCS
Sham tDCS	Sham Comparator	Sham transcranial current direct stimulation. 8 days.	Device: Sham tDCS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active tDCS	Device	Eight sessions of transcranial current direct stimulation	Active tDCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Fatigue	Modified Fatigue Impact Scale (MFIS)	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in cognition	Stroop Test	2 weeks
Change in depressive symptoms	Beck Depression Inventory II	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clínico San Carlos.		Madrid		28040	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D000094024	Post-Acute COVID-19 Syndrome
D005221	Fatigue

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided