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Outcome Measures

Primary Outcomes (1)

Change in fatigue severity measured by the Fatigue Assessment Scale (FAS)
Total score ranges from 10 to 50, with higher scores indicating greater fatigue severity.
From enrollment to the end of treatment at 14 weeks

Secondary Outcomes (4)

Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)
From enrollment to the end of treatment at 14 weeks
Change in self-reported pain intensity measured by the Visual Analogue Scale (VAS)
From enrollment to the end of treatment at 14 weeks

Study Arms (2)

Sequence 1: Sham to Active

EXPERIMENTAL

Participants receive sham tDCS during Period 1 (42 sessions over 3 weeks), followed by a 4-week washout period, and then active tDCS during Period 2 (42 sessions over 3 weeks).

Device: Transcranial Direct Current Stimulation

Sequence 2: Active to shame

EXPERIMENTAL

Participants receive active tDCS during Period 1 (42 sessions over 3 weeks), followed by a 4-week washout period, and then sham tDCS during Period 2 (42 sessions over 3 weeks).

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current StimulationDevice

The intervention utilizes a home-based transcranial direct current stimulation (tDCS) protocol administered autonomously by participants in real-world settings.Transcranial direct current stimulation (tDCS) delivers low-intensity direct electrical current through scalp electrodes in order to modulate cortical excitability and synaptic plasticity. The treatment plan features a specific 3-week tapered schedule per intervention period totaling 42 sessions: Week 1 consists of 3 sessions per day (morning, afternoon, and evening; 21 sessions), Week 2 consists of 2 sessions per day (morning and afternoon; 14 sessions), and Week 3 consists of 1 session per day (any time of day; 7 sessions).

Sequence 1: Sham to ActiveSequence 2: Active to shame

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Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Met the World Health Organization clinical case definition for post-COVID-19 condition
Suffered severe fatigue (Fatigue Assessment Scale \[FAS\] score ≥42).

Contact the study team to confirm eligibility.

MeSH Terms

Conditions

Mental FatigueChronic PainPost-Acute COVID-19 SyndromeFatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorPainNeurologic ManifestationsCOVID-19Pneumonia, ViralPneumonia

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Purpose

TREATMENT

Intervention Model

CROSSOVER

Model Details: This is a randomized, double-blind, crossover trial where participants are allocated in a 1:1 ratio to one of two sequences. Sequence 1 receives sham tDCS in Period 1 followed by active tDCS in Period 2. Sequence 2 receives active tDCS in Period 1 followed by sham tDCS in Period 2. A 4-week washout period separates the two treatment phases to prevent carryover effects.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Medicine and surgery and Neurologist

Intensive Home-based Transcranial Direct Current Stimulation for Long COVID

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Sequence 1: Sham to Active

Sequence 2: Active to shame

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Sequence 1: Sham to Active

Sequence 2: Active to shame

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations