Trial Outcomes & Findings for Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD) (NCT NCT05478681)

NCT ID: NCT05478681

Last Updated: 2025-10-10

Results Overview

The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

week 2

Results posted on

2025-10-10

Participant Flow

Participant milestones

Participant milestones
Measure
Active tDCS
All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. active tDCS: All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down.
Overall Study
STARTED
3
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: week 2

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: week 4

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: week 6

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: week 12

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: week 2

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

side effects include itching, burning, headache, fatigue, and dizziness.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: week 4

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

side effects include itching, burning, headache, fatigue, and dizziness.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: week 6

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

side effects include itching, burning, headache, fatigue, and dizziness.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 6, week 12

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 6 and Week 12.

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever), higher scores indicate more apathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 6 and Week 12.

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

This questionnaire has 19 questions and each is scored from 0(absent) to 2(severe). A total score greater than 10 indicates probable major depressive episode and a score of greater than 18 indicates definite major depressive episode

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 6 and Week 12.

Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Mini-Mental State Examination (MMSE) includes memory, language, praxis and orientation tasks, yielding a global cognition score ranging 0 to 30, with higher scores indicating better performance.

Outcome measures

Outcome data not reported

Adverse Events

Active tDCS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kendra M Anderson, PhD

The University of Texas Health Science Center at Houston

Phone: 713-486-0513

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place