Trial Outcomes & Findings for Neuromodulation of Cognition in Older Adults (NCT NCT02137122)

Last Updated: 2023-05-08

Results Overview

The NIH Toolbox is a battery of neurocognitive tests created by the National Institute on Aging as a comprehensive measure of cognitive function. We used the change from baseline to two week post test in the NIH Toolbox Fluid Cognition Composite Score (FCC) to assess outcome. The uncorrected standard score of the FCC was used. The FCC is derived by averaging the standard scores of the NIH Toolbox Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting, and Pattern Comparison tests and then deriving standard scores based on this new distribution. The uncorrected standard score is on a scale of mean = 100, standard deviation = 15. Higher positive scores mean a greater improvement at the post test. Difference scores ranged from a minimum of -7 to a maximum of 19. FCC scores ranged from a minimum of 73 to a maximum of 112 in this sample. On a population level percentiles are reported from a minimum score of 59 to a maximum of 140, covering 99.3% of the population.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

baseline up to two week post test

Results posted on

2023-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Cognitive Training + Active tDCS Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. Transcranial Direct Current Stimulation: Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.	Cognitive Training + Sham tDCS Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. Sham Stimulation: Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
Overall Study STARTED	15	16
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuromodulation of Cognition in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Training + Active tDCS n=15 Participants Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. Transcranial Direct Current Stimulation: Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.	Cognitive Training + Sham tDCS n=16 Participants Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. Sham Stimulation: Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.	Total n=31 Participants Total of all reporting groups
Age, Continuous	73.3 years STANDARD_DEVIATION 7.6 • n=93 Participants	73.9 years STANDARD_DEVIATION 6.7 • n=4 Participants	73.6 years STANDARD_DEVIATION 7.1 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Race/Ethnicity, Customized African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	16 participants n=4 Participants	31 participants n=27 Participants
NIH toolbox fluid cognition uncorrected standard score	93.0 units on a scale STANDARD_DEVIATION 8.6 • n=93 Participants	88.9 units on a scale STANDARD_DEVIATION 12.3 • n=4 Participants	90.9 units on a scale STANDARD_DEVIATION 10.7 • n=27 Participants

PRIMARY outcome

Timeframe: baseline up to two week post test

Population: 1 participant in the Cognitive Training + Sham tDCS group listed in the baseline characteristics section withdrew prior to post test, reducing the number from 16 to 15 in this group.

Outcome measures

Outcome measures
Measure	Cognitive Training + Active tDCS n=15 Participants Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. Transcranial Direct Current Stimulation: Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.	Cognitive Training + Sham tDCS n=15 Participants Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. Sham Stimulation: Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
Change in NIH Toolbox Fluid Cognition Composite Score	4.7 units on a scale Standard Deviation 7.9	6.1 units on a scale Standard Deviation 5.5

Adverse Events

Cognitive Training + Active tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Training + Sham tDCS

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive Training + Active tDCS n=15 participants at risk Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. Transcranial Direct Current Stimulation: Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.	Cognitive Training + Sham tDCS n=16 participants at risk Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. Sham Stimulation: Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
Cardiac disorders Hospitalization (High blood pressure)	0.00% 0/15 • Adverse event data were recorded between randomization to intervention and three month follow-up.	6.2% 1/16 • Number of events 1 • Adverse event data were recorded between randomization to intervention and three month follow-up.

Other adverse events

Adverse event data not reported

Additional Information

Adam Woods

University of Florida

Phone: 352-294-5842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place