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NCT00453921 · ClinicalTrials.gov registry record · NA
Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI)
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
NCT00453921 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 76 participants.
The verdict
NCT00453921, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
Study Summary
Traumatic brain injury (TBI) is a significant public health problem, with 1.5-2.0 million Americans injured each year. Cognitive deficits, particularly in the domains of memory and attention are frequently the source of lingering disability after TBI and a source of enormous distress to the injured individuals and their family/caregivers. To date, interventions to ameliorate chronic cognitive deficits have been directed at either pharmacological interventions or cognitive rehabilitation. We propose to (1) To compare the efficacy of three interventions: memory and attention training (MAAT), methylphenidate, and memory/attention training in combination with methylphenidate and (2) use functional MRI (fMRI) to characterize changes in activation of the neural circuitry of memory and attention due to MAAT alone, methylphenidate alone, and MAAT in combination with methylphenidate. This is a two by two design with medication (methylphenidate/placebo) and cognitive therapy (Memory and Attention Training (MAAT) or an Attention control intervention) as possible interventions. Using a randomized, placebo-controlled, double-blind design, 200 individuals with persistent cognitive deficits 6-12 months after MTBI will be randomized to receive a six week trial of either (1) MAAT and placebo, (2) MAAT and methylphenidate (0.3 mg/kg BID), (3) attention control intervention and methylphenidate (0.3 mg/kg BID), or (4) attention control intervention and placebo. Symptom distress, attention and memory performance, and activation patterns of the neural circuitry of attention and memory while undergoing fMRI will be characterized at baseline, and after the four treatment conditions. This study will provide important information on three interventions for the most disabling sequelae of an enormous public health problem. Further, it will help to clarify underlying neural mechanisms and suggest additional treatment possibilities.
Interventions
- DRUG Methylphenidate
- BEHAVIORAL Memory and Attention Training
- OTHER Placebo as both treatments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2007-02 |
| Est. Completion | 2013-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00453921
The ClinicalTrials.gov registry entry for NCT00453921 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Methylphenidate is the first listed.
NCT00453921 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00453921 about?
NCT00453921 is a clinical study titled "Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI)". Traumatic brain injury (TBI) is a significant public health problem, with 1.5-2.0 million Americans injured each year. Cognitive deficits, particularly in the domains of memory and attention are frequently the source of lingering disability after TBI and a source of enormous distress to the injured ...
What is the current status of trial NCT00453921?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2007-02. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00453921?
The interventions under investigation include: Methylphenidate (DRUG), Memory and Attention Training (BEHAVIORAL), Placebo as both treatments (OTHER).
Who is sponsoring clinical trial NCT00453921?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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