Trial Outcomes & Findings for Transcranial Direct Current Stimulation for Primary Progressive Aphasia (NCT NCT02928848)

Last Updated: 2021-06-03

Results Overview

The Western Aphasia Battery (WAB) was administered at baseline and immediately post-tDCS (real; sham) following the termination of the tDCS session on the same day (0 week). We computed WAB-Aphasia Quotient (WAB-AQ), a measure of overall aphasia severity with higher scores indicating better language performance. The WAB assesses the following language domains in subtests: fluency, comprehension, repetition, and naming. We examined change in WAB-AQ and each of the sub-tests from baseline. Difference scores were computed by subtracting the post-intervention score (0 weeks) from baseline for each study arm to assess the impact of real/active vs sham tDCS on severity and each sub-test. Scale title: WAB-AQ; scale values: 0-100; higher scores=better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Difference in WAB-AQ from Baseline at 0-weeks Post-stimulation

Results posted on

2021-06-03

Participant Flow

Recruitment period: 10/2017-11/2019. Patients with Primary Progressive Aphasia will be recruited from the clinical practices of Drs. H. Branch Coslett, Roy Hamilton, and Murray Grossman at the Hospital of the University of Pennsylvania. Additional recruitment measures involve flyers posted around the University of Pennsylvania campus and the Hospital of the University of Pennsylvania grounds, as well as online FTD/PPA support groups and in-person support groups around the Philadelphia area.

16 participants were enrolled in the study. Subjects were enrolled if they were native English speakers, right handed, and received a diagnosis of primary progressive aphasia (PPA). Note that one participant was diagnosed as having PPA at the time of enrollment; however, it was later learned that this was a misdiagnosis and their data were not analyzed. Baseline Characteristics reported for N=13. The washout period between treatment arms was 12 weeks.

Participant milestones

Participant milestones
Measure	Active tDCS, Then Sham tDCS Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. Following a washout period of 12 weeks after active tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received sham tDCS.	Sham tDCS, Then Active tDCS Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. Following a washout period of 12 weeks after sham tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received active tDCS.
Arm 1 STARTED	9	7
Arm 1 COMPLETED	9	6
Arm 1 NOT COMPLETED	0	1
Arm 2 STARTED	9	6
Arm 2 COMPLETED	8	6
Arm 2 NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active tDCS, Then Sham tDCS Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. Following a washout period of 12 weeks after active tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received sham tDCS.	Sham tDCS, Then Active tDCS Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. Following a washout period of 12 weeks after sham tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received active tDCS.
Arm 2 Withdrawal by Subject	1	0

Baseline Characteristics

Transcranial Direct Current Stimulation for Primary Progressive Aphasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS, Then Sham n=7 Participants Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation condition involves 20 minutes of constant stimulation at 1.5 mA. Arm 1 data were collected prior to active tDCS, whereas Arm 2 data reflect performance 12 weeks following active tDCS (prior to crossing over to the sham tDCS treatment arm).	Sham tDCS, Then Active n=6 Participants Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of real tDCS. Arm 1 data were collected prior to sham tDCS, whereas Arm 2 data reflect performance 12 weeks following sham tDCS (prior to crossing over to the active tDCS treatment arm).	Total n=13 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	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	66.29 years STANDARD_DEVIATION 7.67 • n=5 Participants	66.33 years STANDARD_DEVIATION 6.18 • n=7 Participants	66.31 years STANDARD_DEVIATION 6.73 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 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	2 Participants n=7 Participants	2 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	4 Participants n=7 Participants	11 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	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Western Aphasia Battery - Aphasia Quotient (WAB-AQ) Arm 1	79.84 units on a scale STANDARD_DEVIATION 9.68 • n=5 Participants	85.55 units on a scale STANDARD_DEVIATION 7.80 • n=7 Participants	82.38 units on a scale STANDARD_DEVIATION 9.61 • n=5 Participants
Western Aphasia Battery - Aphasia Quotient (WAB-AQ) Arm 2	78.39 units on a scale STANDARD_DEVIATION 9.24 • n=5 Participants	85.55 units on a scale STANDARD_DEVIATION 7.02 • n=7 Participants	81.23 units on a scale STANDARD_DEVIATION 10.10 • n=5 Participants

PRIMARY outcome

Timeframe: Difference in WAB-AQ from Baseline at 0-weeks Post-stimulation

Population: Participants who completed both arms of the study to the 0-week follow-up (N=13). Of the 16 participants enrolled, 3 were excluded from the 0-week follow-up for the following reasons: withdrew prior to starting treatment arm 1 (n=2) and misdiagnosed as PPA (n=1).

Outcome measures

Outcome measures
Measure	Active tDCS, Then Sham tDCS n=7 Participants Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. Following a washout period of 12 weeks after active tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received sham tDCS.	Sham tDCS, Then Active tDCS n=6 Participants Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. Following a washout period of 12 weeks after sham tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received active tDCS.
Aphasia Severity (WAB-AQ): Effects of Active tDCS (Baseline vs. 0 Weeks Immediately Following Stimulation) Arm 1: 0 Week Follow-up	2.68 score on a scale Standard Deviation 2.04	.87 score on a scale Standard Deviation 2.83
Aphasia Severity (WAB-AQ): Effects of Active tDCS (Baseline vs. 0 Weeks Immediately Following Stimulation) Arm 2: 0 Week Follow-up	1.98 score on a scale Standard Deviation 2.75	2.25 score on a scale Standard Deviation 2.04

SECONDARY outcome

Timeframe: Difference in WAB Naming Subtest from Baseline at 0-weeks Post-stimulation

WAB-naming subtest used common objects as stimuli. Participants were required to name the objects. Three-point maximum score could be earned for each stimulus and a total of 60-points could be earned on this task; points were deducted if the response was incorrect and required a cue or if the response included a paraphasia.

Outcome measures

Outcome measures
Measure	Active tDCS, Then Sham tDCS n=7 Participants Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. Following a washout period of 12 weeks after active tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received sham tDCS.	Sham tDCS, Then Active tDCS n=6 Participants Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. Following a washout period of 12 weeks after sham tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received active tDCS.
Naming Ability (WAB Naming Subtest): Effects of Active tDCS Baseline vs. 0 Weeks Immediately Following Stimulation Arm 1: 0-week Follow-up	.63 score on a scale Standard Deviation .49	.11 score on a scale Standard Deviation .59
Naming Ability (WAB Naming Subtest): Effects of Active tDCS Baseline vs. 0 Weeks Immediately Following Stimulation Arm 2: 0-week Follow-up	.26 score on a scale Standard Deviation .83	.63 score on a scale Standard Deviation .35

Adverse Events

Active 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

Dr. H. Branch Coslett

University of Pennsylvania

Phone: 2156623606

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place