Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453921
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2007-03-27
Brief Title:
Methylphenidate Ritalin and MemoryAttention in Traumatic Brain Injury TBI
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Methylphenidate Ritalin and MemoryAttention in Traumatic Brain Injury TBI
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Traumatic brain injury TBI is a significant public health problem with 15-20 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 familycaregivers 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 memoryattention 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 methylphenidateplacebo 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 03 mgkg BID 3 attention control intervention and methylphenidate 03 mgkg 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
Detailed Description:
Summary and Gaps to be Addressed by the Proposed Study
What is known There are two interventions of promising efficacy in ameliorating deficits in attention and memory after mild traumatic brain injury MTBI i memory and attention trainingrehabilitation and ii catecholaminergic augmentation particularly with methylphenidate - which augments both dopaminergic and adrenergic systems fMRI and other functional imaging strategies are providing valuable insights into the underlying neural mechanisms of the cognitive enhancing effects of methylphenidate in some neuropsychiatric populations individuals with ADHD and the effects of cognitive rehabilitation efforts in some domains eg speech and language in individuals after stroke
What is not known To date there are no studies that apply a psychopharmacological strategy of augmenting neurotransmitter systems known to modulate memoryattention dopaminergic and adrenergic systems in combination with a cognitive rehabilitation intervention known to improve memoryattention memoryattention training in individuals with MTBI We are aware of no published studies that use fMRI to assess the neural mechanisms of memoryattention improvement from the use of catecholaminergic agents or memoryattention training in individuals with MTBI It is important to determine the efficacy of combined memoryattention training and methylphenidate It is equally important to begin to understand the neural mechanisms underlying effective treatment as it may help to inform the development of the next generation of interventions and perhaps lead to individually tailored treatment interventions This proposal will start to address these gaps in our knowledge
What is known There are two interventions of promising efficacy in ameliorating deficits in attention and memory after mild traumatic brain injury MTBI i memory and attention trainingrehabilitation and ii catecholaminergic augmentation particularly with methylphenidate - which augments both dopaminergic and adrenergic systems fMRI and other functional imaging strategies are providing valuable insights into the underlying neural mechanisms of the cognitive enhancing effects of methylphenidate in some neuropsychiatric populations individuals with ADHD and the effects of cognitive rehabilitation efforts in some domains eg speech and language in individuals after stroke
What is not known To date there are no studies that apply a psychopharmacological strategy of augmenting neurotransmitter systems known to modulate memoryattention dopaminergic and adrenergic systems in combination with a cognitive rehabilitation intervention known to improve memoryattention memoryattention training in individuals with MTBI We are aware of no published studies that use fMRI to assess the neural mechanisms of memoryattention improvement from the use of catecholaminergic agents or memoryattention training in individuals with MTBI It is important to determine the efficacy of combined memoryattention training and methylphenidate It is equally important to begin to understand the neural mechanisms underlying effective treatment as it may help to inform the development of the next generation of interventions and perhaps lead to individually tailored treatment interventions This proposal will start to address these gaps in our knowledge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HD047242 | NIH | None | httpsreporternihgovquickSearch5R01HD047242 |