Dysexecutive Syndrome, Post-Acute Sequelae of COVID-19
Conditions
Keywords
Transcranial Direct Current Stimulation, EEG, Sustained attention
Brief summary
The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.
Interventions
DEVICEActive tDCS
2 mA of anodal stimulation will be applied to the left prefrontal cortex over the F3 electrode based on the International 10-10 EEG system.
DEVICESham tDCS
Sham stimulation will be applied to the left prefrontal cortex over the F3 electrode.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ability to provide informed consent * A diagnosis of PASC as indicated by past COVID-19 infection, and persistent symptoms, including 'brain fog', confusion, short-term memory deficits, trouble concentrating, delirium, difficulties in multitasking.
Exclusion criteria
* History of epilepsy * Metallic implants in the head and neck, * Brain stimulators * Pacemakers * Pregnancy * Active substance dependence (except for tobacco) * Premorbid major neurological illness * Severe mental illness (e.g., bipolar disorder, schizophrenia) * Attention Deficit Hyperactivity Disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inhibitory Control | Baseline | Performance during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly. |
| Processing Speed | Baseline | Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention) |
| EEG P300 Event-related Potential | Baseline | EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Flexibility | Baseline | Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control. |
| Working Memory | Baseline | Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance. |
| Episodic Memory | Baseline | Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 7 / 16 | 9 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
None listed