Trial Outcomes & Findings for Optimizing Current and Electrode Montage for Transcranial Direct Current Stimulation in Stroke Patients (NCT NCT02763826)

Last Updated: 2021-10-13

Results Overview

Major response is any of the following: * Second degree scalp burn at the site of electrode pad; or * Seizure; or * New lesion(s) on Diffusion Weighted Imaging (DWI) sequence of MRI scan and the lesion(s) not explained by any other cause(s) or decreased Apparent Diffusion Coefficient (ADC) under the electrode stimulating motor cortex area; * Discontinuation of subject from the study due to any of above. In a 3+3 design, 3 subjects are recruited for a given tDCS dose level. The trial is stopped if ≥2 of 3 subjects at a given tDCS dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given tDCS dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next tDCS dose level. Maximum tolerable dose will be the tDCS dose at the level before stopping of the trial.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Immediately after intervention on the day of tDCS application

Results posted on

2021-10-13

Participant Flow

Part 1 was a 3+3 dose-escalation study, which allowed up to 6 participants at a given dose escalation step. Part 2 was a montage effect study, which was a cross-over study requiring 18 participants to finish the study (by completing 3 visits). Participants enrolled in Part 1 were allowed to be enrolled in Part 2, but repeat participation in the same part by the same subject was not allowed.

Participant milestones

Participant milestones
Measure	1 mA Bihemispheric tDCS Subjects will get tDCS at a current of 1 mA with bihemispheric montage	2 mA Bihemispheric tDCS Subjects will get tDCS at a current of 2 mA with bihemispheric montage	2.5 mA Bihemispheric tDCS Subjects will get tDCS at a current of 2.5 mA with bihemispheric montage	3 mA Bihemispheric tDCS Subjects will get tDCS at a current of 3 mA with bihemispheric montage	3.5 mA Bihemispheric tDCS Subjects will get tDCS at a current of 3.5 mA with bihemispheric montage	4 mA Bihemispheric tDCS Subjects will get tDCS at a current of 4 mA with bihemispheric montage	4 mA Anodal tDCS Subjects will get tDCS at a current of 4 mA with anodal montage	4 mA Cathodal tDCS Subjects will get tDCS at a current of 4 mA with cathodal montage
Part 1 Dose Escalation, 1 mA STARTED	3	0	0	0	0	0	0	0
Part 1 Dose Escalation, 1 mA COMPLETED	3	0	0	0	0	0	0	0
Part 1 Dose Escalation, 1 mA NOT COMPLETED	0	0	0	0	0	0	0	0
Part 1 Dose Escalation, 2 mA STARTED	0	3	0	0	0	0	0	0
Part 1 Dose Escalation, 2 mA COMPLETED	0	3	0	0	0	0	0	0
Part 1 Dose Escalation, 2 mA NOT COMPLETED	0	0	0	0	0	0	0	0
Part 1 Dose Escalation, 2.5 mA STARTED	0	0	3	0	0	0	0	0
Part 1 Dose Escalation, 2.5 mA COMPLETED	0	0	3	0	0	0	0	0
Part 1 Dose Escalation, 2.5 mA NOT COMPLETED	0	0	0	0	0	0	0	0
Part 1 Dose Escalation, 3 mA STARTED	0	0	0	3	0	0	0	0
Part 1 Dose Escalation, 3 mA COMPLETED	0	0	0	3	0	0	0	0
Part 1 Dose Escalation, 3 mA NOT COMPLETED	0	0	0	0	0	0	0	0
Part 1 Dose Escalation, 3.5 mA STARTED	0	0	0	0	3	0	0	0
Part 1 Dose Escalation, 3.5 mA COMPLETED	0	0	0	0	3	0	0	0
Part 1 Dose Escalation, 3.5 mA NOT COMPLETED	0	0	0	0	0	0	0	0
Part 1 Dose Escalation, 4 mA STARTED	0	0	0	0	0	3	0	0
Part 1 Dose Escalation, 4 mA COMPLETED	0	0	0	0	0	3	0	0
Part 1 Dose Escalation, 4 mA NOT COMPLETED	0	0	0	0	0	0	0	0
Part 2 Montage Effect, 1st Intervention STARTED	0	0	0	0	0	6	6	7
Part 2 Montage Effect, 1st Intervention COMPLETED	0	0	0	0	0	6	6	7
Part 2 Montage Effect, 1st Intervention NOT COMPLETED	0	0	0	0	0	0	0	0
Part 2 Montage Effect, 2nd Intervention STARTED	0	0	0	0	0	6	6	6
Part 2 Montage Effect, 2nd Intervention COMPLETED	0	0	0	0	0	6	6	6
Part 2 Montage Effect, 2nd Intervention NOT COMPLETED	0	0	0	0	0	0	0	0
Part 2 Montage Effect, 3rd Intervention STARTED	0	0	0	0	0	6	6	6
Part 2 Montage Effect, 3rd Intervention COMPLETED	0	0	0	0	0	6	6	6
Part 2 Montage Effect, 3rd Intervention NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 mA Bihemispheric tDCS n=3 Participants Participants received 1 mA Bihemispheric tDCS	2 mA Bihemispheric tDCS n=3 Participants Participants received 2 mA Bihemispheric tDCS	2.5 mA Bihemispheric tDCS n=3 Participants Participants received 2.5 mA Bihemispheric tDCS	3 mA Bihemispheric tDCS n=3 Participants Participants received 3 mA Bihemispheric tDCS	3.5 mA Bihemispheric tDCS n=3 Participants Participants received 3.5 mA Bihemispheric tDCS	4 mA Bihemispheric tDCS n=3 Participants Participants received 4 mA Bihemispheric tDCS	Crossover - 4mA Bihemisphere tDCS and 4 mA Anodal tDCS and 4mA Cathodal tDCS n=13 Participants Stroke subjects will each receive one of three stimulation montages	Total n=31 Participants Total of all reporting groups
Age, Categorical Dose Escalation · <=18 years	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=18 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Age, Categorical Dose Escalation · Between 18 and 65 years	2 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	3 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	3 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	3 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	3 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	16 Participants n=18 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Age, Categorical Dose Escalation · >=65 years	1 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=18 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Age, Categorical Crossover · <=18 years	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Age, Categorical Crossover · Between 18 and 65 years	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	9 Participants n=13 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	9 Participants n=13 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Age, Categorical Crossover · >=65 years	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	4 Participants n=13 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	4 Participants n=13 Participants • Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Sex: Female, Male Dose Escalation · Female	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	7 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Sex: Female, Male Dose Escalation · Male	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	3 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	11 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Sex: Female, Male Crossover · Female	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	6 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	6 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Sex: Female, Male Crossover · Male	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	7 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	7 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Dose Escalation · American Indian or Alaska Native	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Dose Escalation · Asian	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Dose Escalation · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Dose Escalation · Black or African American	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	7 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Dose Escalation · White	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	1 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	2 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	10 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Dose Escalation · More than one race	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Dose Escalation · Unknown or Not Reported	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=3 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=18 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Crossover · American Indian or Alaska Native	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Crossover · Asian	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Crossover · Native Hawaiian or Other Pacific Islander	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Crossover · Black or African American	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	00 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	7 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	7 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Crossover · White	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	6 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	6 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Crossover · More than one race	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Race (NIH/OMB) Crossover · Unknown or Not Reported	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.	0 Participants n=13 Participants • Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period.
Region of Enrollment United States · Dose Escalation	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	0 Participants n=13 Participants	18 Participants n=31 Participants
Region of Enrollment United States · Crossover Period	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	13 Participants n=13 Participants	13 Participants n=31 Participants

PRIMARY outcome

Timeframe: Immediately after intervention on the day of tDCS application