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tDCS in Post-COVID Syndrome: Comparison of Two Targets

Primary Purpose

COVID-19, Post-COVID-19 Syndrome, Post COVID-19 Condition

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
transcranial current direct stimulation
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring post-COVID syndrome, brain stimulation, fatigue, cognitive, depression, transcranial direct current stimulation, non-invasive brain stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed diagnosis of COVID-19 at least 6 months before the participation in the study. Diagnosis of post-COVID condition according to WHO criteria. Age 18-65 years. Spanish as native language. Sign of written informed consent. Exclusion Criteria: History of stroke History of traumatic brain injury or central nervous system infection Diagnosis of other neurological or medical disorder that could impact on fatigue. Diagnosis of active psychiatric disorder potentially impacting on fatigue or cognitive function. Chemotherapy or radiotherapy for cancer. Severe sensory deficits (e.g. visual loss) that could limit assessments included int the study protocol. Taking drugs or uncontrolled medical disorder potentially causing or worsening fatigue. Specifically, uncontrolled adrenal insufficiency, miastenic syndromes, thyroid disorders, cardiac failure, chronic kidney disorders and neurodegenerative disorders are excluded. History of abuse of alcohol or other toxics. Any contraindication for transcranial electric stimulation: epilepsy, pregnancy, metallic implants, brain devices, pacemakers, head injuries).

Sites / Locations

  • Hospital Clínico San Carlos.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Left dorsolateral prefrontal cortex

Left M1

Arm Description

15 sessiones of anodal tDCS over the left dorsolateral prefrontal cortex (2 mA, 20 minutes) associated with cognitive training.

15 sessiones of anodal tDCS over the left M1 (2 mA, 20 minutes) associated with cognitive training.

Outcomes

Primary Outcome Measures

Fatigue Severity Scale (score)
Physical fatigue

Secondary Outcome Measures

Modified Fatigue Impact Scale (MFIS) (score)
Physical and cognitive fatigue
FLEI scale (score)
Subjective cognition.
Beck Depression Inventory (2nd version) (score)
Depressive symptoms
Pittsburgh Sleep Quality Index (score)
Sleep quality
Brief Pain Inventory (score)
Pain

Full Information

First Posted
March 1, 2023
Last Updated
March 2, 2023
Sponsor
Hospital San Carlos, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05753202
Brief Title
tDCS in Post-COVID Syndrome: Comparison of Two Targets
Official Title
Neuromodulation Using Transcranial Direct Current Stimulation (tDCS) in Post-COVID Syndrome: Comparison of Two Targets
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim of this study is to compare the effect of two non-invasive neuromodulation targets in patients meeting WHO criteria for the post-COVID condition. A randomized, parallel, double-blind study will be conducted. Patients will receive 15 neuromodulation sessions through transcranial electrical stimulation for 3 weeks, associated with cognitive stimulation during therapy. The main objective will be to evaluate the change in physical fatigue. As secondary objectives, changes in cognition, depression, pain, quality of sleep and quality of life will be evaluated. The objective of this study is to evaluate the effect of two targets (left dorsolateral prefrontal and M1) of the neuromodulation intervention, together with cognitive stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Post-COVID-19 Syndrome, Post COVID-19 Condition
Keywords
post-COVID syndrome, brain stimulation, fatigue, cognitive, depression, transcranial direct current stimulation, non-invasive brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left dorsolateral prefrontal cortex
Arm Type
Active Comparator
Arm Description
15 sessiones of anodal tDCS over the left dorsolateral prefrontal cortex (2 mA, 20 minutes) associated with cognitive training.
Arm Title
Left M1
Arm Type
Active Comparator
Arm Description
15 sessiones of anodal tDCS over the left M1 (2 mA, 20 minutes) associated with cognitive training.
Intervention Type
Device
Intervention Name(s)
transcranial current direct stimulation
Intervention Description
Transcranial electrical stimulation over two different brain regions associated with cognitive training. 15 sesions in 3 weeks (5 days/week)
Primary Outcome Measure Information:
Title
Fatigue Severity Scale (score)
Description
Physical fatigue
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Modified Fatigue Impact Scale (MFIS) (score)
Description
Physical and cognitive fatigue
Time Frame
1 month
Title
FLEI scale (score)
Description
Subjective cognition.
Time Frame
1 month
Title
Beck Depression Inventory (2nd version) (score)
Description
Depressive symptoms
Time Frame
1 month
Title
Pittsburgh Sleep Quality Index (score)
Description
Sleep quality
Time Frame
1 month
Title
Brief Pain Inventory (score)
Description
Pain
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of COVID-19 at least 6 months before the participation in the study. Diagnosis of post-COVID condition according to WHO criteria. Age 18-65 years. Spanish as native language. Sign of written informed consent. Exclusion Criteria: History of stroke History of traumatic brain injury or central nervous system infection Diagnosis of other neurological or medical disorder that could impact on fatigue. Diagnosis of active psychiatric disorder potentially impacting on fatigue or cognitive function. Chemotherapy or radiotherapy for cancer. Severe sensory deficits (e.g. visual loss) that could limit assessments included int the study protocol. Taking drugs or uncontrolled medical disorder potentially causing or worsening fatigue. Specifically, uncontrolled adrenal insufficiency, miastenic syndromes, thyroid disorders, cardiac failure, chronic kidney disorders and neurodegenerative disorders are excluded. History of abuse of alcohol or other toxics. Any contraindication for transcranial electric stimulation: epilepsy, pregnancy, metallic implants, brain devices, pacemakers, head injuries).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi A Matias-Guiu, PhD MD
Phone
913303000
Ext
3711
Email
jordi.matias-guiu@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi A Matias-Guiu, PhD
Organizational Affiliation
Hospital Clinico San Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico San Carlos.
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi A Matias-Guiu, PhD
Phone
+34676933312
Email
jordimatiasguiu@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
After the end of the study and publication of the results. For 5 years.
IPD Sharing Access Criteria
Data will be shared after reasonable request to the principal investigator.

Learn more about this trial

tDCS in Post-COVID Syndrome: Comparison of Two Targets

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