An interventional study of Active Transcranial Direct Stimulation in Brain Fog, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Device feasibility
Cognitive impairment refers to when an individual struggles to learn, concentrate, remember, or make decisions. This can be due to underlying neurological diseases (i.e. Alzheimer's disease, dementia, etc.), caused by viral illness (i.e. brain fog experienced by COVID-19 survivors) or physical trauma (i.e. concussion). Recent reports indicate that two out of three Americans experience some amount of cognitive impairment in their lifetime.
There are a number of therapies that have been used to help address this condition. One of these is transcranial direct current stimulation (tDCS), which delivers sustained direct current to to the head area via electrodes. A number of studies have indicated that this form of therapy is safe and efficacious at inducing neuroplasticity and exciting neuronal activity. These factors can help improve aspects of cognitive functioning such as working memory, learning, and task performance.
The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless, transcranial direct current stimulation for people with cognitive impairments.
Sample size (n=10) is convenient and designed to explore acceptability and feasibility. Participants who are enrolled will be provided a tDCS device to use for a period of four weeks. They will have two study visits, baseline (BL) and the 4th week visit (W4). During each visit participants will answer various questionnaires to assess patient-reported outcomes such as sleep quality, cognitive impairment, depression, anxiety, fatigue, and user acceptability.
The entire cohort will receive a transcranial direct stimulation (tDCS) device which uses LIFTiD Neurostimulation technology (RPW TECHNOLOGY, LLC, New York, USA). Participants will take the device home and daily, they will use the device for a maximum of 20 minutes to stimulate neuroplasticity. During the stimulation period they will be asked to perform a light activity such as reading, checking emails, etc. The participants will return to the McNair Campus for their final visit after 4 weeks.
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This study's enrollment of 10 is below the median of 47 across 124 interventional studies indexed under Mental Fatigue.
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Exclusion Criteria:
Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.
Device: Active Transcranial Direct Stimulation
Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.
Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score)
The perceived ease of use of tDCS will be assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire. Participants will rate the device on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) across seven questions. The total score will range from 7 (extremely difficult) to 35 (extremely easy), with higher scores indicating greater ease of use. Questions will assess: (1) ease of use, (2) sponge preparation, (3) attaching sponges, (4) starting/stopping therapy, (5) charging, (6) mobility while wearing the device, and (7) task completion during use. The TAM subscore will be calculated by summing individual scores, with median values reported as an overall measure of ease of use.
Time frame: At 4 weeks
Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score)
The perceived usefulness of tDCS was assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire. Participants rated the usefulness of the device on a 5-point scale: 1 = Decreased Significantly, 2 = Decreased, 3 = Neutral, 4 = Increased, 5 = Increased Significantly. Six questions were used to assess overall perceived usefulness, focusing on benefits related to mental activity, energy levels, memory, attention, concentration, and alertness. The total score ranged from 6 (not at all useful) to 30 (highly useful), with higher values indicating greater perceived usefulness. The TAM subscore for perceived usefulness was calculated by summing the individual component scores and determining the median value across participants.
Time frame: At 4 weeks
Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score)
The attitude toward use of the tDCS device was assessed using a subscale of the Technology Acceptance Model (TAM) questionnaire. Participants will rate their attitude toward use on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) based on two questions: (1) I would continue this therapy after completing the study, and (2) I would recommend this therapy to friends/family. The total score ranges from 2 (extremely difficult) to 10 (extremely easy), with higher scores reflecting a more positive attitude toward the device. The TAM subscore is calculated by summing individual component scores, with median values reported, providing an overall measure of perceived ease of use and intention to use.
Time frame: At 4 weeks
Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline
A digit memory test assesses short-term and working memory by having participants recall sequences of numbers presented in either the same order (forward) or reverse order (backward). Scores are based on the longest sequence accurately recalled, with higher scores indicating better memory capacity. This test is commonly used in cognitive evaluations and research to monitor memory function and detect impairments. Percentage of changes in the total score were assessed at the 4-week mark compared to baseline. The range will be -100% to +100%. A score of zero indicates no change in memory performance, positive values reflect improvement, and negative values indicate a decline in memory performance. The average scores for all analyzed participants were reported.
Time frame: Baseline - 4 weeks
Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline
The Hopkins Verbal Learning Test-Revised (HVLT-R) is a brief neuropsychological tool assessing verbal learning and memory. Participants recall 12 words across three trials (max score: 36) and a delayed recall trial (max score: 12), yielding a total score of 48, with higher scores indicating better memory. Percentage changes in cumulative scores from baseline to week 4 were evaluated, with averages reported across all participants who completed the study. Scores range from -100% to +100%, where positive values indicate improvement, zero denotes no change, and negative values reflect a decline.
Time frame: Baseline - 4 weeks
Changes in Trail Making Task (TMT) From Baseline
The Trail Making Task (TMT) is a neuropsychological test used to assess attention, processing speed, and task-switching. It consists of two parts: Part A (connecting numbered circles sequentially) and Part B (alternating between numbers and letters). Performance is measured in seconds (completion time) and errors, with shorter times and fewer mistakes indicating better cognitive function. This study reported changes in TMT completion times at week 4 compared to baseline for both parts. Negative values indicate improvement (reduction in completion time compared to baseline) in cognitive function.
Time frame: Baseline - 4 weeks
Change in MoCA Score at 4 Weeks Compared to Baseline
Cognitive status was assessed using the Montreal Cognitive Assessment (MoCA), which provides a score ranging from 0 to 30. Changes in scores from baseline to week 4 were reported, with positive values indicating improvement and negative values reflecting deterioration.
Time frame: Baseline - 4 weeks
| Milestone | Transcranial Direct Stimulation |
|---|---|
| Started | 10 |
| Completed | 5 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Adverse event | 2 |
| Withdrew: Withdrawal by subject | 1 |
The perceived ease of use of tDCS will be assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire. Participants will rate the device on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) across seven questions. The total score will range from 7 (extremely difficult) to 35 (extremely easy), with higher scores indicating greater ease of use. Questions will assess: (1) ease of use, (2) sponge preparation, (3) attaching sponges, (4) starting/stopping therapy, (5) charging, (6) mobility while wearing the device, and (7) task completion during use. The TAM subscore will be calculated by summing individual scores, with median values reported as an overall measure of ease of use.
| units on a scale | Transcranial Direct Stimulation |
|---|---|
| Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score) | 30.5 ± 4.8 |
The perceived usefulness of tDCS was assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire. Participants rated the usefulness of the device on a 5-point scale: 1 = Decreased Significantly, 2 = Decreased, 3 = Neutral, 4 = Increased, 5 = Increased Significantly. Six questions were used to assess overall perceived usefulness, focusing on benefits related to mental activity, energy levels, memory, attention, concentration, and alertness. The total score ranged from 6 (not at all useful) to 30 (highly useful), with higher values indicating greater perceived usefulness. The TAM subscore for perceived usefulness was calculated by summing the individual component scores and determining the median value across participants.
| units on a scale | Transcranial Direct Stimulation |
|---|---|
| Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score) | 22.5 ± 4.5 |
The attitude toward use of the tDCS device was assessed using a subscale of the Technology Acceptance Model (TAM) questionnaire. Participants will rate their attitude toward use on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) based on two questions: (1) I would continue this therapy after completing the study, and (2) I would recommend this therapy to friends/family. The total score ranges from 2 (extremely difficult) to 10 (extremely easy), with higher scores reflecting a more positive attitude toward the device. The TAM subscore is calculated by summing individual component scores, with median values reported, providing an overall measure of perceived ease of use and intention to use.
| units on a scale | Transcranial Direct Stimulation |
|---|---|
| Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score) | 9 ± 3.5 |
A digit memory test assesses short-term and working memory by having participants recall sequences of numbers presented in either the same order (forward) or reverse order (backward). Scores are based on the longest sequence accurately recalled, with higher scores indicating better memory capacity. This test is commonly used in cognitive evaluations and research to monitor memory function and detect impairments. Percentage of changes in the total score were assessed at the 4-week mark compared to baseline. The range will be -100% to +100%. A score of zero indicates no change in memory performance, positive values reflect improvement, and negative values indicate a decline in memory performance. The average scores for all analyzed participants were reported.
| Percent change | Transcranial Direct Stimulation |
|---|---|
| Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline | 2.5 ± 11.4 |
The Hopkins Verbal Learning Test-Revised (HVLT-R) is a brief neuropsychological tool assessing verbal learning and memory. Participants recall 12 words across three trials (max score: 36) and a delayed recall trial (max score: 12), yielding a total score of 48, with higher scores indicating better memory. Percentage changes in cumulative scores from baseline to week 4 were evaluated, with averages reported across all participants who completed the study. Scores range from -100% to +100%, where positive values indicate improvement, zero denotes no change, and negative values reflect a decline.
| Percent change | Transcranial Direct Stimulation |
|---|---|
| Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline | 45.8 ± 27.3 |
The Trail Making Task (TMT) is a neuropsychological test used to assess attention, processing speed, and task-switching. It consists of two parts: Part A (connecting numbered circles sequentially) and Part B (alternating between numbers and letters). Performance is measured in seconds (completion time) and errors, with shorter times and fewer mistakes indicating better cognitive function. This study reported changes in TMT completion times at week 4 compared to baseline for both parts. Negative values indicate improvement (reduction in completion time compared to baseline) in cognitive function.
| seconds | Transcranial Direct Stimulation |
|---|---|
| Part A | -0.9 ± 11.5 |
| Part B | -4.8 ± 15.3 |
Cognitive status was assessed using the Montreal Cognitive Assessment (MoCA), which provides a score ranging from 0 to 30. Changes in scores from baseline to week 4 were reported, with positive values indicating improvement and negative values reflecting deterioration.
| score on a scale | Transcranial Direct Stimulation |
|---|---|
| Change in MoCA Score at 4 Weeks Compared to Baseline | -0.33 ± 1.63 |
Collected over up to 4 weeks post initiation of intervention. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transcranial Direct Stimulation | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) |
| Event | Transcranial Direct Stimulation |
|---|---|
| HeadchesGeneral disorders | 1/10 |
| PainGeneral disorders | 1/10 |
| Age, Categorical(Participants) | Transcranial Direct Stimulation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Transcranial Direct Stimulation |
|---|---|
| Female | 5 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Transcranial Direct Stimulation |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Transcranial Direct Stimulation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Transcranial Direct Stimulation |
|---|---|
| United States | 10 |
| MOCA Score(units on a scale) | Transcranial Direct Stimulation |
|---|---|
| Mean | 26.3 ± 3.92 |
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Baylor College of Medicine