Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS) (NCT NCT05524233)

Last Updated: 2025-03-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

At 4 weeks

Results posted on

2025-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	2
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Transcranial Direct Current Stimulation (tDCS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Direct Stimulation n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
MOCA Score	26.3 units on a scale STANDARD_DEVIATION 3.92 • n=5 Participants

PRIMARY outcome

Timeframe: At 4 weeks

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

Outcome measures

Outcome measures
Measure	Transcranial Direct Stimulation n=5 Participants 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.
Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score)	30.5 units on a scale Standard Deviation 4.8

PRIMARY outcome

Timeframe: At 4 weeks

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

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.

Outcome measures

Outcome measures
Measure	Transcranial Direct Stimulation n=5 Participants 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.
Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score)	22.5 units on a scale Standard Deviation 4.5

PRIMARY outcome

Timeframe: At 4 weeks

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

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.

Outcome measures

Outcome measures
Measure	Transcranial Direct Stimulation n=5 Participants 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.
Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score)	9 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 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 performance, positive values reflect improvement, and negative values indicate a decline in memory performance. The average scores for all analyzed participants were reported.

Outcome measures

Outcome measures
Measure	Transcranial Direct Stimulation n=5 Participants 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.
Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline	2.5 Percent change Standard Deviation 11.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transcranial Direct Stimulation n=5 Participants 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.
Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline	45.8 Percent change Standard Deviation 27.3

SECONDARY outcome

Timeframe: 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 function.

Outcome measures

Outcome measures
Measure	Transcranial Direct Stimulation n=5 Participants 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.
Changes in Trail Making Task (TMT) From Baseline Part A	-0.9 seconds Standard Deviation 11.5
Changes in Trail Making Task (TMT) From Baseline Part B	-4.8 seconds Standard Deviation 15.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transcranial Direct Stimulation n=5 Participants 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.
Change in MoCA Score at 4 Weeks Compared to Baseline	-0.33 score on a scale Standard Deviation 1.63

Adverse Events

Transcranial Direct Stimulation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transcranial Direct Stimulation n=10 participants at risk 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.
General disorders Headches	10.0% 1/10 • Number of events 1 • up to 4 weeks post initiation of intervention The definition used will be the same as the clinicaltrials.gov definition.
General disorders Pain	10.0% 1/10 • Number of events 1 • up to 4 weeks post initiation of intervention The definition used will be the same as the clinicaltrials.gov definition.

Additional Information

Bijan Najafi

Baylor College of Medicine

Phone: 7137987536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place