NCT05524233: tDCS

Transcranial Direct Current Stimulation (tDCS)

Completed NA Results posted Last updated 7 March 2025

What this trial tests

NA trial testing Active Transcranial Direct Stimulation in Brain Fog in 10 participants. Completed in 17 April 2023.

Timeline

29 September 2022

Primary endpoint
17 April 2023

17 April 2023

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	10
Start date	29 September 2022
Primary completion	17 April 2023
Estimated completion	17 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Active Transcranial Direct Stimulation

Conditions studied

• Brain Fog — all drugs for Brain Fog →

Sponsor

Baylor College of Medicine

Who can join

18 and older, any sex, with Brain Fog. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score) Primary · At 4 weeks

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 TA

Group	Value	95% CI
Transcranial Direct Stimulation	30.5	± 4.8

Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score) Primary · At 4 weeks

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.

Group	Value	95% CI
Transcranial Direct Stimulation	22.5	± 4.5

Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score) Primary · At 4 weeks

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 c

Group	Value	95% CI
Transcranial Direct Stimulation	9	± 3.5

Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline Secondary · Baseline - 4 weeks

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 performa

Group	Value	95% CI
Transcranial Direct Stimulation	2.5	± 11.4

Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline Secondary · Baseline - 4 weeks

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.

Group	Value	95% CI
Transcranial Direct Stimulation	45.8	± 27.3

Changes in Trail Making Task (TMT) From Baseline Secondary · Baseline - 4 weeks

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 functio

Part A

Group	Value	95% CI
Transcranial Direct Stimulation	-0.9	± 11.5

Part B

Group	Value	95% CI
Transcranial Direct Stimulation	-4.8	± 15.3

Change in MoCA Score at 4 Weeks Compared to Baseline Secondary · Baseline - 4 weeks

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.

Group	Value	95% CI
Transcranial Direct Stimulation	-0.33	± 1.63

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 4 weeks post initiation of intervention. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Transcranial Direct Stimulation

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (2 terms — click to expand)

Reaction	System	Transcranial Direct Stimul…
Headches	General disorders	—
Pain	General disorders	—

Data from ClinicalTrials.gov NCT05524233 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.