Trial Outcomes & Findings for Dextroamphetamine and tDCS to Improve the Fluency (NCT NCT02514044)
NCT ID: NCT02514044
Last Updated: 2018-08-03
Results Overview
The score on the Language Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
immediately before the treatment, immediately after the treatment
Results posted on
2018-08-03
Participant Flow
Participant milestones
| Measure |
Dexedrine+tDCS+Speech Therapy, Then Placebo+tDCS+Speech Therap
10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day Dexedrine: 10 mg immediate release of Dexedrine Active tDCS: 1.5 mA tDCS anodal tDCS Speech Therapy: 60 min of speech therapy
Placebo, 1.5 mA anodal tDCS, and speech therapy for 1 day Active tDCS: 1.5 mA tDCS anodal tDCS Speech Therapy: 60 min of speech therapy Placebo
|
|---|---|
|
Dexedrine+tDCS+Speech Therapy (1 Day)
STARTED
|
10
|
|
Dexedrine+tDCS+Speech Therapy (1 Day)
COMPLETED
|
10
|
|
Dexedrine+tDCS+Speech Therapy (1 Day)
NOT COMPLETED
|
0
|
|
Washout (1 Week)
STARTED
|
10
|
|
Washout (1 Week)
COMPLETED
|
10
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
|
Placebo+tDCS+Speech Therapy (1 Day)
STARTED
|
10
|
|
Placebo+tDCS+Speech Therapy (1 Day)
COMPLETED
|
10
|
|
Placebo+tDCS+Speech Therapy (1 Day)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dextroamphetamine and tDCS to Improve the Fluency
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day Dexedrine: 10 mg immediate release of Dexedrine Active tDCS: 1.5 mA tDCS anodal tDCS Speech Therapy: 60 min of speech therapy
Placebo, 1.5 mA anodal tDCS, and speech therapy for 1 day Active tDCS: 1.5 mA tDCS anodal tDCS Speech Therapy: 60 min of speech therapy Placebo
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
|
Non-fluent aphasia assessed by clinicians
|
10 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: immediately before the treatment, immediately after the treatmentThe score on the Language Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.
Outcome measures
| Measure |
Dexedrine+tDCS+Speech Therapy
n=10 Participants
The subjects received 10 mg D-AMP 30 minutes before the 60 minutes of SLT; first 20 min is simultaneous tDCS stimulation in this experiment/arm.
|
Placebo+tDCS+Speech Therapy
n=10 Participants
The subjects received placebo 30 minutes before the 60 minutes of SLT; first 20 min is simultaneous tDCS stimulation in this experiment/arm.
|
|---|---|---|
|
Percent Change in Language Quotient as Assessed by the Western Aphasia Battery
|
11.02 percent change in language quotient
Interval 3.22 to 18.81
|
-4.2 percent change in language quotient
Interval -10.57 to 2.26
|
PRIMARY outcome
Timeframe: immediately before the treatment, immediately after the treatmentThe score on the Aphasia Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.
Outcome measures
| Measure |
Dexedrine+tDCS+Speech Therapy
n=10 Participants
The subjects received 10 mg D-AMP 30 minutes before the 60 minutes of SLT; first 20 min is simultaneous tDCS stimulation in this experiment/arm.
|
Placebo+tDCS+Speech Therapy
n=10 Participants
The subjects received placebo 30 minutes before the 60 minutes of SLT; first 20 min is simultaneous tDCS stimulation in this experiment/arm.
|
|---|---|---|
|
Percent Change in Aphasia Quotient as Assessed by the Western Aphasia Battery
|
7.9 percent change in aphasia quotient
Interval 1.49 to 14.31
|
-.02 percent change in aphasia quotient
Interval -7.63 to 7.19
|
SECONDARY outcome
Timeframe: Baseline,2 weeksPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline,2 monthsPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: immediately before the treatment, after after the treatmentNon-invasive BP measurements performed by a clinician before and after each experiment.
Outcome measures
| Measure |
Dexedrine+tDCS+Speech Therapy
n=10 Participants
The subjects received 10 mg D-AMP 30 minutes before the 60 minutes of SLT; first 20 min is simultaneous tDCS stimulation in this experiment/arm.
|
Placebo+tDCS+Speech Therapy
n=10 Participants
The subjects received placebo 30 minutes before the 60 minutes of SLT; first 20 min is simultaneous tDCS stimulation in this experiment/arm.
|
|---|---|---|
|
Percent Change in Blood Pressure
Systolic blood pressure
|
10 percent change in blood pressure
Standard Deviation 3
|
4 percent change in blood pressure
Standard Deviation 1
|
|
Percent Change in Blood Pressure
Diastolic blood pressure
|
11 percent change in blood pressure
Standard Deviation 5
|
5 percent change in blood pressure
Standard Deviation 2
|
Adverse Events
D-AMP+tDCS+Speech Therapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo+tDCS+Speech Therapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-AMP+tDCS+Speech Therapy
n=10 participants at risk
The subjects received 10 mg of D-AMP medication 30 minutes before the simultaneous tDCS (first 20 min) and 60 min of SLT in this experiment.
|
Placebo+tDCS+Speech Therapy
n=10 participants at risk
The subjects received placebo medication 30 minutes before the simultaneous tDCS (first 20 min) and 60 min of SLT in this experiment.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Non-significant skin redness and tingling
|
90.0%
9/10 • Number of events 9
|
90.0%
9/10 • Number of events 9
|
|
Nervous system disorders
Mild Headache
|
20.0%
2/10 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Mild Insomnia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
Additional Information
Dr. Gerard E. Francisco, Chairman and Professor, Physical Medicine and Rehabilitation
University of Texas Health Science Center at Houston (UTHealth)
Phone: 713.797.5246
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place