tDCS in Post-COVID Syndrome: Comparison of Two Targets

COVID-19 Clinical Trial

Official title:

Neuromodulation Using Transcranial Direct Current Stimulation (tDCS) in Post-COVID Syndrome: Comparison of Two Targets

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05753202
• Other study ID #: 22/728-P-EC
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome
• Syndrome

Intervention

Device:
• transcranial current direct stimulation
Transcranial electrical stimulation over two different brain regions associated with cognitive training. 15 sesions in 3 weeks (5 days/week)

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos.	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale (score)	Physical fatigue	1 month
Secondary	Modified Fatigue Impact Scale (MFIS) (score)	Physical and cognitive fatigue	1 month
Secondary	FLEI scale (score)	Subjective cognition.	1 month
Secondary	Beck Depression Inventory (2nd version) (score)	Depressive symptoms	1 month
Secondary	Pittsburgh Sleep Quality Index (score)	Sleep quality	1 month
Secondary	Brief Pain Inventory (score)	Pain	1 month