Trial Outcomes & Findings for Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias (NCT NCT04457973)

NCT ID: NCT04457973

Last Updated: 2023-10-13

Results Overview

Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) is a 10 question scale, each question rated from 0-10. The total score ranges between 0-100 with a higher number indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

baseline (day 1), end of intervention (day 5)

Results posted on

2023-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Active tDCS Active tDCS: tDCS with a constant current intensity of 2 milliampere (mA) will be applied for 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.	Sham tDCS Sham tDCS: The electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds out of 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS n=20 Participants 2mA current is applied for 20 minutes.	Sham tDCS n=20 Participants 2mA current is applied for 30 seconds.	Total n=40 Participants Total of all reporting groups
Age, Continuous	74.10 years STANDARD_DEVIATION 6.20 • n=5 Participants	71.90 years STANDARD_DEVIATION 8.97 • n=7 Participants	73 years STANDARD_DEVIATION 7.83 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline (day 1), end of intervention (day 5)

Population: Comparison of pain intensity changes between two groups at 5 days from baseline

Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) is a 10 question scale, each question rated from 0-10. The total score ranges between 0-100 with a higher number indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.

Outcome measures

Outcome measures
Measure	Active tDCS n=20 Participants 2mA current is applied for 20 minutes.	Sham tDCS n=20 Participants 2mA current is applied for 30 seconds.
Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale	-2.70 score on a scale Standard Deviation 2.39	-.40 score on a scale Standard Deviation 1.67

SECONDARY outcome

Timeframe: baseline (day 1), end of intervention (day 5)

Population: Comparison of pain intensity changes between two groups at 5 days from baseline

Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable). The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.

Outcome measures

Outcome measures
Measure	Active tDCS n=20 Participants 2mA current is applied for 20 minutes.	Sham tDCS n=20 Participants 2mA current is applied for 30 seconds.
Clinical Pain as Assessed by a Numerical Rating Scale (NRS)	-13.55 score on a scale Standard Deviation 14.90	-3.30 score on a scale Standard Deviation 14.81

SECONDARY outcome

Timeframe: baseline (day 1), end of intervention (day 5)

Population: Comparison of CMAI score changes between two groups at 5 days from baseline

Cohen-Mansfield Agitation Inventory (CMAI) is a 29 question scale, each question measured from 1-7. Total score ranges from 29-203 with a higher score indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.

Outcome measures

Outcome measures
Measure	Active tDCS n=20 Participants 2mA current is applied for 20 minutes.	Sham tDCS n=20 Participants 2mA current is applied for 30 seconds.
Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)	-2.35 score on a scale Standard Deviation 5.99	-2.95 score on a scale Standard Deviation 5.24

SECONDARY outcome

Timeframe: baseline (day 1), end of intervention (day 5)

Population: Comparison of NPI score changes between two groups at 5 days from baseline

Neuropsychiatric Inventory (NPI) total score ranges from 0-144, with a higher score indicating greater symptoms. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.

Outcome measures

Outcome measures
Measure	Active tDCS n=20 Participants 2mA current is applied for 20 minutes.	Sham tDCS n=20 Participants 2mA current is applied for 30 seconds.
Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)	-2.9 score on a scale Standard Deviation 15.08	-2.30 score on a scale Standard Deviation 11.59

SECONDARY outcome

Timeframe: baseline (day 1), end of intervention (day 5)

Population: Comparison of Beta value changes between two groups at 5 days from baseline.

Pain-related cortical response will be measured during thermal pain stimulation using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) composed of 8 source and 8 detector channels. fNIRS signals between each source-to-detector pair are analyzed using a general linear model, Y = X\*Beta + E , to test for statistical differences between the baseline (day 1) and the end of intervention (day 5). Y is the measured fNIRS signal, X is an array encoding the expected/hypothetical response, E is an error term, and Beta is interpreted as the strength/amplitude of the functional activation. Greater absolute Beta values denote that the change in cortical response between two sessions is greater. The calculated Beta values are expressed in arbitrary units.

Outcome measures

Outcome measures
Measure	Active tDCS n=20 Participants 2mA current is applied for 20 minutes.	Sham tDCS n=20 Participants 2mA current is applied for 30 seconds.
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System source 1, detector 1	-6.39 Beta value	-5.30 Beta value
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System source 2, detector 2	2.31 Beta value	-4.64 Beta value
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System source 3, detector 3	-3.60 Beta value	3.13 Beta value
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System source 4, detector 4	-8.35 Beta value	-3.46 Beta value
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System source 5, detector 5	-1.03 Beta value	-1.54 Beta value
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System source 6, detector 6	-1.99 Beta value	-3.49 Beta value
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System source 7, detector 7	-1.61 Beta value	-0.97 Beta value
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System source 8, detector 8	3.88 Beta value	8.33 Beta value

SECONDARY outcome

Timeframe: end of intervention (day 5)

Population: Comparison of total score of tDCS experience questionnaire between two groups at 5 days from baseline.

The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree. Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 reversed questions. Total score ranges from 0-100 with a most desirable score of a 70.

Outcome measures

Outcome measures
Measure	Active tDCS n=20 Participants 2mA current is applied for 20 minutes.	Sham tDCS n=20 Participants 2mA current is applied for 30 seconds.
Acceptability as Measured by the tDCs Experience Questionnaire	62.05 score on a scale Standard Deviation 8.76	67.95 score on a scale Standard Deviation 11.06

SECONDARY outcome

Timeframe: end of intervention (day 5)

Population: Comparison of total score of CSQ between two groups at 5 days from baseline.

Client Satisfaction Questionnaire (CSQ) consists of 8 questions, each is rated between 1-4. The total score ranges from 8-32 with a higher score indicating a higher satisfaction.

Outcome measures

Outcome measures
Measure	Active tDCS n=20 Participants 2mA current is applied for 20 minutes.	Sham tDCS n=20 Participants 2mA current is applied for 30 seconds.
Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)	28.75 score on a scale Standard Deviation 2.92	28.55 score on a scale Standard Deviation 3.14

Adverse Events

Active tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham 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

Dr. Hyochol Ahn

University of Arizona

Phone: 520-626-1769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place