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Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation (tDCS) For Improvement Of Cognitive Functioning, Brain Fog, And Working Memory

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05524233
Acronym
tDCS
Enrollment
10
Registered
2022-09-01
Start date
2022-09-29
Completion date
2023-04-17
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Fog

Keywords

Cognitive impairment, Brain fog, Transcranial stimulation

Brief summary

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.

Detailed description

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.

Interventions

DEVICEActive Transcranial Direct Stimulation

Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

All participants will be part of the intervention group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults (aged 18+) suffering from poor working memory, brain fog, or cognitive impairments (such as dementia, Alzheimer's, concussions, etc); ability to attend to the clinic for visits

Exclusion criteria

* Severe cognitive decline that reduces their ability to interact with the tDCS device; Major visual or hearing weakness reduces the ability to interact with tDCS device; Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), previous major amputations, and claudication; Demand-type cardiac pacemaker, implanted defibrillator, implanted metal plate in the brain or head, or other implanted electronic devices; Epilepsy, seizures, brain lesions, or severe heart disease; Sensitive skin or rash, broken skin, or open wounds; Pregnancy; and any conditions that may interfere with outcomes or increase the risk of the use tDCS based on the judgement of clinicians

Design outcomes

Primary

MeasureTime frameDescription
Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score)At 4 weeksThe 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.
Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score)At 4 weeksThe 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.
Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score)At 4 weeksThe 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.

Secondary

MeasureTime frameDescription
Changes in Trail Making Task (TMT) From BaselineBaseline - 4 weeksThe 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.
Change in Digit Memory Test Average Score at 4 Weeks Compared to BaselineBaseline - 4 weeksA 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.
Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to BaselineBaseline - 4 weeksThe 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.

Other

MeasureTime frameDescription
Change in MoCA Score at 4 Weeks Compared to BaselineBaseline - 4 weeksCognitive 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Transcranial Direct Stimulation
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. Active Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.
10
Total10

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event2
Overall StudyLost to Follow-up2
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicTranscranial Direct Stimulation
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
MOCA Score26.3 units on a scale
STANDARD_DEVIATION 3.92
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 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
10 Participants
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
2 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

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

Population: The population includes the participants that completed the study.

ArmMeasureValue (MEDIAN)Dispersion
Transcranial Direct StimulationAttitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score)9 units on a scaleStandard Deviation 3.5
Primary

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

Population: The population includes the participants that completed the study.

ArmMeasureValue (MEDIAN)Dispersion
Transcranial Direct StimulationPerceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score)30.5 units on a scaleStandard Deviation 4.8
Primary

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

Population: The population includes the participants that completed the study.

ArmMeasureValue (MEDIAN)Dispersion
Transcranial Direct StimulationPerceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score)22.5 units on a scaleStandard Deviation 4.5
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Transcranial Direct StimulationChange in Digit Memory Test Average Score at 4 Weeks Compared to Baseline2.5 Percent changeStandard Deviation 11.4
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Transcranial Direct StimulationChange in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline45.8 Percent changeStandard Deviation 27.3
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Transcranial Direct StimulationChanges in Trail Making Task (TMT) From BaselinePart A-0.9 secondsStandard Deviation 11.5
Transcranial Direct StimulationChanges in Trail Making Task (TMT) From BaselinePart B-4.8 secondsStandard Deviation 15.3
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Transcranial Direct StimulationChange in MoCA Score at 4 Weeks Compared to Baseline-0.33 score on a scaleStandard Deviation 1.63

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026