Trial Outcomes & Findings for Transcranial Direct Stimulation (tDCS) and Behavioral Intervention in Aphasia (NCT NCT02226796)
NCT ID: NCT02226796
Last Updated: 2022-10-18
Results Overview
Participants are shown one or 3 possible banks of pictures balanced for phonemic complexity which are randomly assigned to prevent learning effect. Each bank contains 15 items. Time to recall is measured using a stop watch. The mean time to recall across all items is calculated and reported in milliseconds. The smaller the number, the faster / better the reaction time is.
COMPLETED
NA
3 participants
40 minutes
2022-10-18
Participant Flow
Participant milestones
| Measure |
Primed tDCS Condition First, Then Non-Prime Condition
The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
The non-primed (NONPRIMED) condition, or sham/control is an intervention that will consist of presentation of sham tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
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Non-Prime Condition First, Then Primed Condition
The non-primed (NONPRIMED) condition, or sham/control is an intervention that will consist of presentation of sham tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
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First Intervention Phase (Week 1)
STARTED
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2
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1
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First Intervention Phase (Week 1)
Baseline Assessment
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2
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1
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First Intervention Phase (Week 1)
Follow Up Assessment
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2
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1
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First Intervention Phase (Week 1)
COMPLETED
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2
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1
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First Intervention Phase (Week 1)
NOT COMPLETED
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0
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0
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Washout (Weeks 2-5)
STARTED
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2
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1
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Washout (Weeks 2-5)
COMPLETED
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2
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1
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Washout (Weeks 2-5)
NOT COMPLETED
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0
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0
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Second Intervention Phase (Week 6)
STARTED
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2
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1
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Second Intervention Phase (Week 6)
Baseline Assessment
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2
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1
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Second Intervention Phase (Week 6)
Follow Up Assessment
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2
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1
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Second Intervention Phase (Week 6)
COMPLETED
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2
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1
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Second Intervention Phase (Week 6)
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Direct Stimulation (tDCS) and Behavioral Intervention in Aphasia
Baseline characteristics by cohort
| Measure |
Sham Controlled tDCS Combined With Behavioral Naming Treatment
n=3 Participants
The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
The non-prime (NONPRIME) condition, sham/control is an intervention that will consist of 40 minutes of naming treatment only, followed by an additional 20 minutes of concurrent naming treatment with a-tDCS.
Behavioral measures taken include: working memory, naming reaction time and naming accuracy
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Age, Continuous
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58.33 years
STANDARD_DEVIATION 18.44 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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3 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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3 Participants
n=5 Participants
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Working Memory
AudioVisual_LongWordLength
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16.33 units on a scale
STANDARD_DEVIATION 12.97 • n=5 Participants
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Working Memory
AudioVisual_ShortWordLength
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17 units on a scale
STANDARD_DEVIATION 12.72 • n=5 Participants
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Working Memory
AudioVisual_WordSpan
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18.66 units on a scale
STANDARD_DEVIATION 11.58 • n=5 Participants
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Working Memory
Visual_DigitSpan
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8.66 units on a scale
STANDARD_DEVIATION 3.39 • n=5 Participants
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Working Memory
Visual_PhonologicallySimilarWords
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7.66 units on a scale
STANDARD_DEVIATION 6.12 • n=5 Participants
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Working Memory
Visual_PhonologicallyDissimilarWords
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12.5 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
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Working Memory
Visual_LongWordLength
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6 units on a scale
STANDARD_DEVIATION 4.24 • n=5 Participants
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Working Memory
Visual_ShortWordLength
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9.66 units on a scale
STANDARD_DEVIATION 5.79 • n=5 Participants
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Working Memory
Visual_WordSpan
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11 units on a scale
STANDARD_DEVIATION 3.26 • n=5 Participants
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Working Memory
Total Score
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148 units on a scale
STANDARD_DEVIATION 102.30 • n=5 Participants
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Western Aphasia Battery Score
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52.23 units on a scale
STANDARD_DEVIATION 12.30 • n=5 Participants
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Boston Naming Test
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12 units on a scale
STANDARD_DEVIATION 0.81 • n=5 Participants
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Naming Reaction Time
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2986.03 time in milliseconds
STANDARD_DEVIATION 1260.48 • n=5 Participants
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Naming Accuracy
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4.48 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
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PRIMARY outcome
Timeframe: 40 minutesPopulation: This is a single subject cross over design where all three participants received both prime and non-prime condition
Participants are shown one or 3 possible banks of pictures balanced for phonemic complexity which are randomly assigned to prevent learning effect. Each bank contains 15 items. Time to recall is measured using a stop watch. The mean time to recall across all items is calculated and reported in milliseconds. The smaller the number, the faster / better the reaction time is.
Outcome measures
| Measure |
Prime Condition
n=3 Participants
The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to the dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention.
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Non-Prime Condition/Control
n=3 Participants
The non-primed (NON-PRIME) condition, or sham controlled, is an intervention that will consist of presentation of sham tDCS to the dorsolateral prefrontal cortex for 20 minutes prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention.
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Naming Reaction Time
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1829.11 milliseconds
Standard Deviation 643.40
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3345.97 milliseconds
Standard Deviation 1428.38
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PRIMARY outcome
Timeframe: 40 minutesParticipants are shown one of 3 possible banks of pictures balanced for phonemic complexity which are randomly assigned to prevent learning effect. Each bank contains 15 items. Each trial is scored by an examiner as accurate (1) or inaccurate (0) based on articulatory accuracy of the participant's response. The average of all trials is calculated for each participant. Total scores range from 0-15 with higher scores indicating better naming accuracy/performance.
Outcome measures
| Measure |
Prime Condition
n=3 Participants
The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to the dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention.
|
Non-Prime Condition/Control
n=3 Participants
The non-primed (NON-PRIME) condition, or sham controlled, is an intervention that will consist of presentation of sham tDCS to the dorsolateral prefrontal cortex for 20 minutes prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention.
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|---|---|---|
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Naming Accuracy
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5.95 units on a scale
Standard Deviation 2.59
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6.044 units on a scale
Standard Deviation 2.32
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SECONDARY outcome
Timeframe: 30 minutesPopulation: The Co-PI collected data using the Boston Naming Test at baseline (before either prime or non-prime condition) and after both conditions were complete. No BNT data was collected between the two conditions, therefore we cannot determine the impact of the prime condition on BNT scores. Flawed execution of this outcome measure.
The Boston Naming Test contains 60 line drawings of objects ranging from very common objects to less familiar. The examiner scores each item + or - according to scoring procedures. Total scores are calculated by adding up the number correct. Scores range from 0 to 60. Higher scores indicate greater ability to name objects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 minutesPopulation: The Co-PI collected data using the Western Aphasia Battery at baseline (before either prime or non-prime condition) and after both conditions were complete. No BNT data was collected between the two conditions, therefore we cannot determine the impact of the prime condition on WAB scores. Flawed execution of this outcome measure.
The Western Aphasia Battery, a standardized assessment of language for individuals with aphasia, contains 32 short tasks. Each task has a separate scoring scheme yielding 8 sub-scores. Total score range from 0-100 with lower scores indicating greater aphasia severity. A score between 0-25 is very severe aphasia, 26-50 is severe aphasia, 51-75 is moderate aphasia, and 76-above is mild aphasia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPopulation: The Co-PI collected data using the working memory assessment at baseline (before either prime or non-prime condition) and after both conditions were complete. No BNT data was collected between the two conditions, therefore we cannot determine the impact of the prime condition on working memory scores. Flawed execution of this outcome measure.
During the Working Memory battery, participants complete 12 auditory only or auditory \& visual computer-based recall tasks. Twelve subset scores are calculated. Ten subtest ranges from 0-40 and 2 range from 0-60. Total score is calculated as sum of subtest scores and ranges from 0-520 with higher scores indicating greater working memory.
Outcome measures
Outcome data not reported
Adverse Events
Primed tDCS Condition
Non-Prime Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sharyl Samargia-Grivette
University of Minnesota Duluth
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place