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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. |
|
| Sham tDCS | Sham Comparator | This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhibitory Control | 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. | Baseline |
| Inhibitory Control | Performance during the incongruent trials of the Eriksen Flanker Task were assessed approximately approximately 4-weeks after baseline. 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. | Posttreatment (1 month follow-up) |
| Processing Speed | 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) | Baseline |
| Processing Speed | Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. | Posttreatment (1 month follow-up) |
| EEG P300 Event-related Potential | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Flexibility | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. |
| FG001 | Sham tDCS | This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inhibitory Control | 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. | Data for this outcome were missing at either baseline or posttreatment time points for 3 participants. | Posted | Mean | Standard Deviation | Ratio of correct responses | Baseline |
|
from baseline until end of treatment (4-weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment | Adverse event was assessed by having participants complete a brief questionnaire on the presence and severity of possible adverse events after each at-home tDCS session. Events at moderate severity and above meet the criteria for "adverse event". |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hamdi Eryilmaz, PhD | Massachusetts General Hospital | (617) 643-7462 | hamdi.eryilmaz@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2023 | Mar 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Sham tDCS | Device | Sham stimulation will be applied to the left prefrontal cortex over the F3 electrode. |
|
| Baseline |
| EEG P300 Event-related Potential | EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. 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. | Posttreatment (1 month follow-up) |
| Baseline |
| Cognitive Flexibility | 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. | Posttreatment (1 month follow-up) |
| Working Memory | 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. | Baseline |
| Working Memory | 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. | Posttreatment (1 month follow-up) |
| Episodic Memory | 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. | Baseline |
| Episodic Memory | 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. | Posttreatment (1 month follow-up) |
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Sham tDCS |
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. |
|
|
| Primary | Inhibitory Control | Performance during the incongruent trials of the Eriksen Flanker Task were assessed approximately approximately 4-weeks after baseline. 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. | Data for this outcome were missing at either baseline or posttreatment time points for 3 participants. | Posted | Mean | Standard Deviation | Ratio of correct responses | Posttreatment (1 month follow-up) |
|
|
|
| Primary | Processing Speed | 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) | Data for this outcome were missing at either baseline or posttreatment time points for 3 participants. | Posted | Mean | Standard Deviation | miliseconds | Baseline |
|
|
|
| Secondary | Cognitive Flexibility | 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. | Posted | Mean | Standard Deviation | Performance score (higher the better) | Baseline |
|
|
|
| Secondary | Cognitive Flexibility | 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. | Posted | Mean | Standard Deviation | Performance score (higher the better) | Posttreatment (1 month follow-up) |
|
|
|
| Secondary | Working Memory | 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. | Posted | Mean | Standard Deviation | Performance score (higher the better) | Baseline |
|
|
|
| Primary | Processing Speed | Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. | Data for this outcome were missing at either baseline or posttreatment time points for 3 participants. | Posted | Mean | Standard Deviation | miliseconds | Posttreatment (1 month follow-up) |
|
|
|
| Primary | EEG P300 Event-related Potential | 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. | Data for this outcome were missing at either baseline or posttreatment time points for 4 participants. | Posted | Mean | Standard Deviation | microvolts | Baseline |
|
|
|
| Primary | EEG P300 Event-related Potential | EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. 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. | Data for this outcome were missing at either baseline or posttreatment time points for 4 participants. | Posted | Mean | Standard Deviation | microvolts | Posttreatment (1 month follow-up) |
|
|
|
| Secondary | Working Memory | 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. | Posted | Mean | Standard Deviation | Performance score (higher the better) | Posttreatment (1 month follow-up) |
|
|
|
| Secondary | Episodic Memory | 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. | Posted | Mean | Standard Deviation | Performance score (higher the better) | Baseline |
|
|
|
| Secondary | Episodic Memory | 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. | Posted | Mean | Standard Deviation | Performance score (higher the better) | Posttreatment (1 month follow-up) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | Sham tDCS | This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. | 0 | 15 | 0 | 15 | 9 | 15 |
|
| Neck pain | General disorders | Systematic Assessment | Adverse event was assessed by having participants complete a brief questionnaire on the presence and severity of possible adverse events after each at-home tDCS session. Events at moderate severity and above meet the criteria for "adverse event". |
|
| Scalp pain | General disorders | Systematic Assessment | Adverse event was assessed by having participants complete a brief questionnaire on the presence and severity of possible adverse events after each at-home tDCS session. Events at moderate severity and above meet the criteria for "adverse event". |
|
| Skin tingling | General disorders | Systematic Assessment | Adverse event was assessed by having participants complete a brief questionnaire on the presence and severity of possible adverse events after each at-home tDCS session. Events at moderate severity and above meet the criteria for "adverse event". |
|
| Warmth sensation | General disorders | Systematic Assessment | Adverse event was assessed by having participants complete a brief questionnaire on the presence and severity of possible adverse events after each at-home tDCS session. Events at moderate severity and above meet the criteria for "adverse event". |
|
| Distractibility | General disorders | Systematic Assessment | Adverse event was assessed by having participants complete a brief questionnaire on the presence and severity of possible adverse events after each at-home tDCS session. Events at moderate severity and above meet the criteria for "adverse event". |
|
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| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |