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NCT02225106 · ClinicalTrials.gov registry record · Phase 2
Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT02225106: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT02225106 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02225106, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Deficits in memory, attention, cognitive, and executive functions are the most common disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is implicated in these neural functions and dopaminergic pathways are recognized to be frequently disrupted after TBI. Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine transporters (DAT) and blocking re-uptake. The objectives of this study are to use PET imaging with \[11C\]-raclopride, a D2/D3 receptor ligand, before and after administering methylphenidate, to measure endogenous DA release in patients who are experiencing problems with cognition, attention and executive function in the chronic stage after TBI. In addition, we will use TMS to test short intracortical inhibition, a gamma-aminobutyric acid receptor A (GABAA) - mediated phenomenon, which is under partial DA control, as a measure of dopaminergic activity on and off
Primary Outcome
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 org
Interventions
- DRUG Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-08-06 |
| Est. Completion | 2017-06-21 |
| Phase | Phase 2 |
What the finished NCT02225106 record still lists
NCT02225106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Methylphenidate is the first listed.
NCT02225106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02225106 about?
NCT02225106 is a clinical study titled "Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI". Deficits in memory, attention, cognitive, and executive functions are the most common disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is implicated in these neural functions and dopaminergic pathways are recognized to be frequently disrupted after TBI. Methylphenidat...
What is the current status of trial NCT02225106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2014-08-06. Estimated completion is 2017-06-21.
What interventions are being tested in trial NCT02225106?
The interventions under investigation include: Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT02225106?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02225106's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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