Trial Outcomes & Findings for Brain Stimulation and Aphasia Treatment (NCT NCT01686373)

Last Updated: 2019-08-20

Results Overview

The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Immediately post-treatment

Results posted on

2019-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Activa Dose II Real tDCS Actual delivery of electrical stimulation Activa Dose II Real tDCS	Activa Dose II Sham tDCS Sham delivery of electrical stimulation Activa Dose II Sham tDCS
Overall Study STARTED	34	40
Overall Study Received 15 Treatment Sessions	33	39
Overall Study COMPLETED	31	38
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Activa Dose II Real tDCS Actual delivery of electrical stimulation Activa Dose II Real tDCS	Activa Dose II Sham tDCS Sham delivery of electrical stimulation Activa Dose II Sham tDCS
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	0	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Brain Stimulation and Aphasia Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Activa Dose II Real tDCS n=34 Participants Actual delivery of electrical stimulation Activa Dose II Real tDCS	Activa Dose II Sham tDCS n=40 Participants Sham delivery of electrical stimulation Activa Dose II Sham tDCS	Total n=74 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=5 Participants	60 years STANDARD_DEVIATION 10 • n=7 Participants	60 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	35 Participants n=7 Participants	62 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	40 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately post-treatment

Outcome measures

Outcome measures
Measure	Activa Dose II Real tDCS n=34 Participants Actual delivery of electrical stimulation Activa Dose II Real tDCS	Activa Dose II Sham tDCS n=40 Participants Sham delivery of electrical stimulation Activa Dose II Sham tDCS
The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).	13.9 PNT and Naming 80 score Interval 9.0 to 18.7	8.2 PNT and Naming 80 score Interval 3.8 to 12.6

Adverse Events

Activa Dose II Real tDCS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Activa Dose II Sham tDCS

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Activa Dose II Real tDCS n=34 participants at risk Actual delivery of electrical stimulation Activa Dose II Real tDCS	Activa Dose II Sham tDCS n=40 participants at risk Sham delivery of electrical stimulation Activa Dose II Sham tDCS
Nervous system disorders Convulsion	0.00% 0/34 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).	2.5% 1/40 • Number of events 1 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).

Other adverse events

Other adverse events
Measure	Activa Dose II Real tDCS n=34 participants at risk Actual delivery of electrical stimulation Activa Dose II Real tDCS	Activa Dose II Sham tDCS n=40 participants at risk Sham delivery of electrical stimulation Activa Dose II Sham tDCS
Nervous system disorders Dizziness	2.9% 1/34 • Number of events 1 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).	5.0% 2/40 • Number of events 2 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).
Nervous system disorders Headache	0.00% 0/34 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).	2.5% 1/40 • Number of events 2 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).
Skin and subcutaneous tissue disorders Erythema	5.9% 2/34 • Number of events 2 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).	0.00% 0/40 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).
Vascular disorders Hypertension	0.00% 0/34 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).	2.5% 1/40 • Number of events 1 • Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).

Additional Information

Dr. Julius Fridriksson

University of South Carolina

Phone: 1-803-777-5931

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place