Trial Outcomes & Findings for Effect of Noninvasive Electrical Brain Stimulation on Memory at Different Times of Day in Younger and Older Adults (NCT NCT03723850)
NCT ID: NCT03723850
Last Updated: 2024-05-14
Results Overview
To measure episodic memory performance, participants will perform a recollection task. They will first study picture and word stimuli (encoding phase). On the subsequent memory test (retrieval phase), participants will be asked to differentiate between studied and non-studied items, as well as recollecting the previous format for studied items (i.e. recollecting the picture or word). For each tested item, participants will also be asked to make a confidence judgement about their response. The primary dependent variable (DV) will be the proportion of studied items attributed to the correct source minus the proportion of nonstudied items incorrectly attributed to that same source.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
271 participants
Primary outcome timeframe
This task is performed immediately after tDCS is administered, and lasts approximately 20 minutes.
Results posted on
2024-05-14
Participant Flow
Participants have the right to end their participation at any time. In addition, the PI may terminate participation if a participant is in obvious non-compliance with the study procedures (e.g., responding randomly or sleeping during the cognitive task) or shows signs of moderate or severe adverse events associated with the study procedures (e.g., excessive discomfort with the tDCS electrodes). Enrolled participants may not continue in the study if they meet any of our exclusion criteria.
Participant milestones
| Measure |
Older, Active tDCS, dlPFC
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
2\.
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Older, Sham tDCS, dlPFC
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, dlPFC
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Sham tDCS, dlPFC/Parietal
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to either the left dorsolateral prefrontal cortex (area F3 using the 10-20 EEG system, n = 25), or the left parietal cortex (area P5 using the 10-20 EEG system, n = 25). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, Parietal Cortex
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left parietal cortex (area P5 using the 10-20 EEG system). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
45
|
54
|
52
|
51
|
|
Overall Study
COMPLETED
|
46
|
45
|
51
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
3
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Noninvasive Electrical Brain Stimulation on Memory at Different Times of Day in Younger and Older Adults
Baseline characteristics by cohort
| Measure |
Older, Active tDCS, dlPFC
n=46 Participants
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
2\.
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Older, Sham tDCS, dlPFC
n=45 Participants
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, dlPFC
n=51 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Sham tDCS, dlPFC/Parietal
n=51 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to either the left dorsolateral prefrontal cortex (area F3 using the 10-20 EEG system, n = 25), or the left parietal cortex (area P5 using the 10-20 EEG system, n = 25). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, Parietal Cortex
n=48 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left parietal cortex (area P5 using the 10-20 EEG system). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Total
n=241 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
150 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
91 Participants
n=10 Participants
|
|
Age, Continuous
|
67.56 years
STANDARD_DEVIATION 4.58 • n=5 Participants
|
67.06 years
STANDARD_DEVIATION 4.61 • n=7 Participants
|
20.80 years
STANDARD_DEVIATION 2.90 • n=5 Participants
|
20.90 years
STANDARD_DEVIATION 3.23 • n=4 Participants
|
21.40 years
STANDARD_DEVIATION 3.06 • n=21 Participants
|
39.54 years
STANDARD_DEVIATION 3.68 • n=10 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
148 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
93 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
191 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
39 Participants
n=10 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
121 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
45 participants
n=7 Participants
|
51 participants
n=5 Participants
|
51 participants
n=4 Participants
|
48 participants
n=21 Participants
|
241 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: This task is performed immediately after tDCS is administered, and lasts approximately 20 minutes.Population: Cognitively-normal adults.
To measure episodic memory performance, participants will perform a recollection task. They will first study picture and word stimuli (encoding phase). On the subsequent memory test (retrieval phase), participants will be asked to differentiate between studied and non-studied items, as well as recollecting the previous format for studied items (i.e. recollecting the picture or word). For each tested item, participants will also be asked to make a confidence judgement about their response. The primary dependent variable (DV) will be the proportion of studied items attributed to the correct source minus the proportion of nonstudied items incorrectly attributed to that same source.
Outcome measures
| Measure |
Older, Active tDCS, dlPFC
n=46 Participants
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
2\.
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Older, Sham tDCS, dlPFC
n=45 Participants
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, dlPFC
n=51 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Sham tDCS, dlPFC/Parietal
n=51 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to either the left dorsolateral prefrontal cortex (area F3 using the 10-20 EEG system, n = 25), or the left parietal cortex (area P5 using the 10-20 EEG system, n = 25). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, Parietal Cortex
n=48 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left parietal cortex (area P5 using the 10-20 EEG system). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
|---|---|---|---|---|---|
|
Episodic Memory Performance
|
0.34 proportion of items
Standard Deviation 0.25
|
0.32 proportion of items
Standard Deviation 0.25
|
0.46 proportion of items
Standard Deviation 0.26
|
0.50 proportion of items
Standard Deviation 0.23
|
0.49 proportion of items
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: This task lasts approximately 10 minutes and is performed immediately after the episodic memory task (approximately 20 minutes after the end of the tDCS session).Population: cognitively-normal adults
To measure working memory performance, participants will perform two versions of the N-back task -- a verbal version (i.e., presenting the numbers 1-9 in a varied sequence) and a visuospatial version (i.e., presenting a colored square in one of 9 locations on a 3x3 grid in a varied sequence). The primary DV will be working memory accuracy: proportion of targets correctly identified minus the proportion of lures incorrectly endorsed.
Outcome measures
| Measure |
Older, Active tDCS, dlPFC
n=44 Participants
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
2\.
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Older, Sham tDCS, dlPFC
n=43 Participants
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, dlPFC
n=47 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Sham tDCS, dlPFC/Parietal
n=48 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to either the left dorsolateral prefrontal cortex (area F3 using the 10-20 EEG system, n = 25), or the left parietal cortex (area P5 using the 10-20 EEG system, n = 25). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, Parietal Cortex
n=42 Participants
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left parietal cortex (area P5 using the 10-20 EEG system). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
|---|---|---|---|---|---|
|
Working Memory Performance
|
0.60 proportion of items
Standard Deviation 0.31
|
0.60 proportion of items
Standard Deviation 0.30
|
0.60 proportion of items
Standard Deviation 0.26
|
0.58 proportion of items
Standard Deviation 0.25
|
0.60 proportion of items
Standard Deviation 0.26
|
Adverse Events
Older, Active tDCS, dlPFC
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Older, Sham tDCS, dlPFC
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Younger, Active tDCS, dlPFC
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Younger, Sham tDCS, dlPFC/Parietal
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Younger, Active tDCS, Parietal Cortex
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Older, Active tDCS, dlPFC
n=49 participants at risk
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
2\.
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Older, Sham tDCS, dlPFC
n=45 participants at risk
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, dlPFC
n=54 participants at risk
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Sham tDCS, dlPFC/Parietal
n=52 participants at risk
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to either the left dorsolateral prefrontal cortex (area F3 using the 10-20 EEG system, n = 25), or the left parietal cortex (area P5 using the 10-20 EEG system, n = 25). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Sham tDCS: The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
Younger, Active tDCS, Parietal Cortex
n=51 participants at risk
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left parietal cortex (area P5 using the 10-20 EEG system). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Active tDCS: The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
|
|---|---|---|---|---|---|
|
Investigations
Non-Serious Adverse Events
|
100.0%
49/49 • Number of events 49 • The targeted timeframe was 7 to 12 days per participant, from baseline day to the final testing session.
Does not differ. All adverse experiences will be recorded in the Adverse Events Survey . If the event is classified as a Serious Adverse Event, the PI will be notified immediately.
|
100.0%
45/45 • Number of events 45 • The targeted timeframe was 7 to 12 days per participant, from baseline day to the final testing session.
Does not differ. All adverse experiences will be recorded in the Adverse Events Survey . If the event is classified as a Serious Adverse Event, the PI will be notified immediately.
|
100.0%
54/54 • Number of events 54 • The targeted timeframe was 7 to 12 days per participant, from baseline day to the final testing session.
Does not differ. All adverse experiences will be recorded in the Adverse Events Survey . If the event is classified as a Serious Adverse Event, the PI will be notified immediately.
|
100.0%
52/52 • Number of events 52 • The targeted timeframe was 7 to 12 days per participant, from baseline day to the final testing session.
Does not differ. All adverse experiences will be recorded in the Adverse Events Survey . If the event is classified as a Serious Adverse Event, the PI will be notified immediately.
|
92.2%
47/51 • Number of events 47 • The targeted timeframe was 7 to 12 days per participant, from baseline day to the final testing session.
Does not differ. All adverse experiences will be recorded in the Adverse Events Survey . If the event is classified as a Serious Adverse Event, the PI will be notified immediately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place