Trial Outcomes & Findings for Brain Stimulation and Enhancing Cognition in Older Adults (NCT NCT03653351)
NCT ID: NCT03653351
Last Updated: 2021-07-08
Results Overview
NIH Toolbox Fluid Cognition Composite Score: provides a global assessment of general fluid cognition functioning. Higher scores indicate higher levels of cognitive functioning. A score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average cognitive ability, while scores around 130 suggest superior ability ( in the top 2 percent nationally). Conversely, a score around 85 suggests below-average cognitive ability and a score in the range of 70 or below suggests significant impairment, which may also be indicative of difficulties in general functioning. Fluid abilities are used to solve problems, think and act quickly, and encode new episodic memories. They are presumed to be especially influenced by biological processes and are less dependent on past exposure (learning experiences). There is only one primary outcome. No secondary outcomes were reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
Sham tDCS and MBSR
Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.
Sham Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes).
|
Active tDCS and MBSR
Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.
Active Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Stimulation and Enhancing Cognition in Older Adults
Baseline characteristics by cohort
| Measure |
Sham tDCS and MBSR
n=14 Participants
Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.
Sham Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes).
|
Active tDCS and MBSR
n=12 Participants
Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.
Active Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Twenty-six participants enrolled in the study: 14 were randomized to sham tDCS and 12 to active tDCS.
NIH Toolbox Fluid Cognition Composite Score: provides a global assessment of general fluid cognition functioning. Higher scores indicate higher levels of cognitive functioning. A score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average cognitive ability, while scores around 130 suggest superior ability ( in the top 2 percent nationally). Conversely, a score around 85 suggests below-average cognitive ability and a score in the range of 70 or below suggests significant impairment, which may also be indicative of difficulties in general functioning. Fluid abilities are used to solve problems, think and act quickly, and encode new episodic memories. They are presumed to be especially influenced by biological processes and are less dependent on past exposure (learning experiences). There is only one primary outcome. No secondary outcomes were reported.
Outcome measures
| Measure |
Sham tDCS and MBSR
n=14 Participants
Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.
Sham Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes).
|
Active tDCS and MBSR
n=12 Participants
Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.
Active Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol.
|
|---|---|---|
|
Cognitive and Memory Function
|
56.5 score on a scale
Standard Deviation 6.7
|
49.8 score on a scale
Standard Deviation 7.2
|
Adverse Events
Sham tDCS and MBSR
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Active tDCS and MBSR
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham tDCS and MBSR
n=14 participants at risk
Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.
Sham Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes).
Most of the adverse events in this study were mild and transient. They included tingling, itching, pain and redness on the scalp, and headaches. Three participants reported worsening of their depressive symptoms; however, this did not lead them to discontinue the study. There were no safety issues associated with tDCS. Adherence with tDCS administration and in-class attendance were comparable in the sham and active groups, suggesting that active tDCS did not cause adverse effects or discomfort associated with non-adherence.
|
Active tDCS and MBSR
n=12 participants at risk
Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.
Active Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol.
Most of the adverse events in this study were mild and transient. They included tingling, itching, pain and redness on the scalp, and headaches. Three participants reported worsening of their depressive symptoms; however, this did not lead them to discontinue the study. There were no safety issues associated with tDCS. Adherence with tDCS administration and in-class attendance were comparable in the sham and active groups, suggesting that active tDCS did not cause adverse effects or discomfort associated with non-adherence.
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|---|---|---|
|
Nervous system disorders
Burning and tingling of scalp
|
50.0%
7/14 • Eight weeks
|
50.0%
6/12 • Eight weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place