Trial Outcomes & Findings for Rehabilitating and Decelerating Language Loss in Primary Progressive Aphasia With tDCS Plus Language Therapy (NCT NCT03728582)
NCT ID: NCT03728582
Last Updated: 2023-04-27
Results Overview
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The primary outcome variable will be trained verbs on the Object and Action Naming battery (OANBtrained). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. The OANB includes 100 verbs (15 trained, 85 untrained) and 162 nouns.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Baseline, and 4-7 weeks after treatment begins
Results posted on
2023-04-27
Participant Flow
Participant milestones
| Measure |
Active tDCS Plus Speech-Language Therapy First Then Sham Plus Speech-Language Therapy
Active transcranial direct current stimulation (tDCS) will be applied at the beginning of one-hour speech-language therapy session and will last for 20 min. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context. Therapy is provided 3-5 sessions per week until 15 sessions is reached.This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 1-2 milliamp (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy Then Active tDCS Plus Speech-language Therapy
Sham tDCS will be applied at the beginning of one-hour speech-language therapy session. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context. Therapy is provided 3-5 sessions per week until 15 sessions is reached.This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context.
Active tDCS plus Speech-Language Therapy: 1-2 milliamp (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context.
|
|---|---|---|
|
Intervention Period 1 (up to 6 Weeks)
STARTED
|
3
|
5
|
|
Intervention Period 1 (up to 6 Weeks)
COMPLETED
|
3
|
4
|
|
Intervention Period 1 (up to 6 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout (8 Weeks)
STARTED
|
3
|
4
|
|
Washout (8 Weeks)
COMPLETED
|
2
|
4
|
|
Washout (8 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Intervention Period 2 (Up to 6 Weeks)
STARTED
|
2
|
4
|
|
Intervention Period 2 (Up to 6 Weeks)
COMPLETED
|
2
|
4
|
|
Intervention Period 2 (Up to 6 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Active tDCS Plus Speech-Language Therapy First Then Sham Plus Speech-Language Therapy
Active transcranial direct current stimulation (tDCS) will be applied at the beginning of one-hour speech-language therapy session and will last for 20 min. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context. Therapy is provided 3-5 sessions per week until 15 sessions is reached.This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 1-2 milliamp (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy Then Active tDCS Plus Speech-language Therapy
Sham tDCS will be applied at the beginning of one-hour speech-language therapy session. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context. Therapy is provided 3-5 sessions per week until 15 sessions is reached.This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context.
Active tDCS plus Speech-Language Therapy: 1-2 milliamp (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy provided in 15 one-hour sessions, using verb naming therapy in a sentence context.
|
|---|---|---|
|
Intervention Period 1 (up to 6 Weeks)
Withdrawal by Subject
|
0
|
1
|
|
Washout (8 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Rehabilitating and Decelerating Language Loss in Primary Progressive Aphasia With tDCS Plus Language Therapy
Baseline characteristics by cohort
| Measure |
Active tDCS Plus Speech-Language Therapy Versus Sham Plus Speech-Language Therapy
n=8 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
Active tDCS plus Speech-Language Therapy: 2 milliamp (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 2 mA in a ramp-like fashion for a maximum of 20 minutes. Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Speech-language therapy will be verb naming therapy in a sentence context.
Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
|
|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 5.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, and 4-7 weeks after treatment beginsTo determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The primary outcome variable will be trained verbs on the Object and Action Naming battery (OANBtrained). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. The OANB includes 100 verbs (15 trained, 85 untrained) and 162 nouns.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=7 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy
n=7 Participants
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
|
|---|---|---|
|
Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery (OANB)
|
2.3 score on a scale
Standard Deviation .285
|
2.05 score on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline, and 4-7 weeks after treatment beginsTo determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. There are 100 verbs (15 trained, 85 untrained) on the OANB, and 162 nouns.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=7 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy
n=7 Participants
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
|
|---|---|---|
|
Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
|
5.27 score on a scale
Standard Deviation 0.43
|
-0.408 score on a scale
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline, and 2 months after treatment endsTo determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. There are 100 verbs (15 trained, 85 untrained) and 162 nouns on the OANB.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=7 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy
n=7 Participants
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
|
|---|---|---|
|
Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
|
0.48 score on a scale
Standard Deviation 0.12
|
1.0 score on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline, and 2 months after treatment endsTo determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. There are 100 verbs (15 trained, 85 untrained) on the OANB, and 162 nouns.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=7 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy
n=7 Participants
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
|
|---|---|---|
|
Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Untrained Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
|
4.25 score on a scale
Standard Deviation 0.43
|
-8.84 score on a scale
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline, and 4-7 weeks after treatment beginsThe ASHA FACS will be administered pre-treatment and post-treatment to evaluate changes in functional communication skills. The ASHA FACS is used for measuring the functional communication of adults with speech, language, and cognitive communication disorders. The Communicative Independence Scale will be used, which is rated on a 7-point scale ranging from 1 "does not perform the behavior" to 7 "does perform the behavior". The scores on the Communicative Independence Scale range from a low score of 1 to a high score of 7. A higher score on this subscale indicates better ability to communicate independently.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=7 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy
n=7 Participants
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
|
|---|---|---|
|
Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)
|
0.215 score on a scale
Standard Deviation 0.023
|
-0.08 score on a scale
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline, and 2 months after treatment endsThe ASHA FACS will be administered pre- treatment and post treatment to evaluate changes in functional communication skills. The ASHA FACS is used for measuring the functional communication of adults with speech, language, and cognitive communication disorders. The Communicative Independence Scale will be used, which is rated on a 7-point scale ranging from 1 "does not perform the behavior" to 7 "does perform the behavior". The scores on the Communicative Independence Scale range from a low score of 1 to a high score of 7. A higher score on this subscale indicates better ability to communicate independently.
Outcome measures
| Measure |
Active tDCS Plus Speech-Language Therapy
n=7 Participants
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy
n=7 Participants
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
|
|---|---|---|
|
Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)
|
0.145 score on a scale
Standard Deviation 0.02
|
-0.59 score on a scale
Standard Deviation 0.03
|
Adverse Events
Active tDCS Plus Speech-Language Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Plus Speech-Language Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS Plus Speech-Language Therapy
n=7 participants at risk
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 2 milliamp (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
|
Sham Plus Speech-Language Therapy
n=7 participants at risk
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
Active tDCS plus Speech-Language Therapy: 2 milliamp (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
Sham tDCS plus Speech-Language Therapy: Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 6 months
|
14.3%
1/7 • Number of events 5 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place