tDCS in Post-COVID Syndrome: Comparison of Two Targets

San Carlos Clinical Hospital

Status: Active, not recruiting

Conditions: COVID-19; Post COVID-19 Condition; Post-COVID-19 Syndrome

Treatments: Device: transcranial current direct stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05753202

22/728-P-EC

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

Left dorsolateral prefrontal cortex

Active Comparator group

Description:

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

Treatment:

Device: transcranial current direct stimulation

Left M1

Active Comparator group

Description:

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

Treatment:

Device: transcranial current direct stimulation