Trial Outcomes & Findings for Evaluating Anodal tDCS Preceding Aphasia Therapy (NCT NCT02249819)

Last Updated: 2021-04-05

Results Overview

The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

baseline, discharge

Results posted on

2021-04-05

Participant Flow

All participants received both the active and sham tDCS conditions, and sequence of stimulation conditions was randomized across participants.

Participant milestones

Participant milestones
Measure	Anodal tDCS, Then Sham tDCS Participants first received 1 single 20 min session of anodal tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of sham tDCS + computerized naming therapy.	Sham tDCS, Then Anodal tDCS Participants first received 1 single 20 min session of sham tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of anodal tDCS + computerized naming therapy.
Overall Study STARTED	8	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Anodal tDCS Preceding Aphasia Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=15 Participants Crossover design study: All participants were randomized to receive one single 20 min session of anodal tDCS and 1 single session of sham tDCS followed by computerized naming therapy. Sequence of stimulation conditions was counterbalanced across participants with a 1 week washout period in between conditions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, discharge

Population: All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis.

The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).

Outcome measures

Outcome measures
Measure	Anodal tDCS n=15 Participants Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy in either the first two or the last two weeks of the study.	Sham tDCS n=15 Participants Participants received 1 single 20 min session of sham tDCS + computerized naming therapy in either the first two or the last two weeks of the study.
Mean Change in Picture-naming Accuracy Score Mean Score at Discharge(out of 75)	51.33 score Standard Deviation 17.79	51.00 score Standard Deviation 18.40
Mean Change in Picture-naming Accuracy Score Mean Change from Baseline	5.25 score Standard Deviation 4.85	5.92 score Standard Deviation 5.21

Adverse Events

Anodal 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

Johanna Chang, Senior Research Coordinator

Northwell Health

Phone: (516)562-3646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place