Clinical trial NCT05753202: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Fatigue Severity Scale (score)
timeFrame: 1 month
Secondary outcomes:
measure: Modified Fatigue Impact Scale (MFIS) (score)
timeFrame: 1 month
measure: FLEI scale (score)
timeFrame: 1 month
measure: Beck Depression Inventory (2nd version) (score)
timeFrame: 1 month
measure: Pittsburgh Sleep Quality Index (score)
timeFrame: 1 month
measure: Brief Pain Inventory (score)
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos.
Study officials:
affiliation: Hospital Clinico San Carlos
name: Jordi A Matias-Guiu, PhD
role: PRINCIPAL_INVESTIGATOR
References: