Trial Outcomes & Findings for Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI (NCT NCT02225106)
NCT ID: NCT02225106
Last Updated: 2019-11-15
Results Overview
Relationship between tonic DA release (assessed by displacement of \[11C\] raclopride by oral methylphenidate) and improvement in processing speed after 4 weeks of treatment with oral methylphenidate. The Perceptual organization and processing speed index is measured from the Digit Symbol and Symbol Searches from the Weschler Adult Intelligence Scale (WAIS-IV). The tasks that comprise the PSI, (Coding, Symbol Search), are timed and require attending to visual material, visual perception and organization, visual scanning, and hand-eye coordination. It is a standardized scale were 100 is the mean of a normal population, and each 10 points represents 1 standard deviation above or below the mean. Thus, an index of 110 is 1 SD above the mean, 90 is 1 SD below the mean.
COMPLETED
PHASE2
11 participants
4 weeks
2019-11-15
Participant Flow
Participant milestones
| Measure |
Open Label Methylphenidate Treatment
Forced titration with methylphenidate up to a dose of 30 mg administered orally twice daily.
Methylphenidate: Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated.
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|---|---|
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Overall Study
STARTED
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11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI
Baseline characteristics by cohort
| Measure |
Open Label Methylphenidate Treatment
n=11 Participants
Forced titration with methylphenidate up to a dose of 30 mg administered orally twice daily.
Methylphenidate: Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
33 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 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
|
10 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
|
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Region of Enrollment
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeksRelationship between tonic DA release (assessed by displacement of \[11C\] raclopride by oral methylphenidate) and improvement in processing speed after 4 weeks of treatment with oral methylphenidate. The Perceptual organization and processing speed index is measured from the Digit Symbol and Symbol Searches from the Weschler Adult Intelligence Scale (WAIS-IV). The tasks that comprise the PSI, (Coding, Symbol Search), are timed and require attending to visual material, visual perception and organization, visual scanning, and hand-eye coordination. It is a standardized scale were 100 is the mean of a normal population, and each 10 points represents 1 standard deviation above or below the mean. Thus, an index of 110 is 1 SD above the mean, 90 is 1 SD below the mean.
Outcome measures
| Measure |
Open Label Methylphenidate Treatment
n=11 Participants
Forced titration with methylphenidate up to a dose of 30 mg administered orally twice daily.
Methylphenidate: Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated.
|
|---|---|
|
Perceptual Organization and Processing Speed Index
|
89 score on a scale
Standard Deviation 10
|
Adverse Events
Open Label Methylphenidate Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label Methylphenidate Treatment
n=11 participants at risk
Forced titration with methylphenidate up to a dose of 30 mg administered orally twice daily.
Methylphenidate: Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated.
|
|---|---|
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Nervous system disorders
Insomnia
|
18.2%
2/11 • Number of events 11 • 4 weeks
Adverse events and serious adverse events were collected through structured questionnaires administered at the last study visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place