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NCT01207375 · ClinicalTrials.gov registry record · NA
Improving New Learning and Memory in Traumatic Brain Injury
A NA study, sponsored by Kessler Foundation.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT01207375 is a NA study that has completed, run by Kessler Foundation. The registered enrollment target is 120 participants.
The verdict
NCT01207375, a NA study, has completed, sponsored by Kessler Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in Traumatic Brain Injury (TBI). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with TBI and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with TBI. The current proposal will evaluate (a)the efficacy of this treatment protocol within a TBI population,(b) the impact of the treatment on everyday functioning, (c) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. The investigators will randomly assign individuals with TBI, with documented impairment in new learning abilities, to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to evaluate the efficacy of this particular memory retraining technique in a TBI population through the assessment of cognitive function via a standard evaluation. In addition, the investigators will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other. Optional enrollment in pre/post neuroimaging will also allow us to look at changes in the brain.
Interventions
- BEHAVIORAL memory retraining exercises
- BEHAVIORAL placebo control memory exercises
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2008-01 |
| Est. Completion | 2014-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01207375
The ClinicalTrials.gov registry entry for NCT01207375 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kessler Foundation, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which memory retraining exercises is the first listed.
NCT01207375 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01207375 about?
NCT01207375 is a clinical study titled "Improving New Learning and Memory in Traumatic Brain Injury". The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in Traumatic Brain Injury (TBI). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with TBI and...
What is the current status of trial NCT01207375?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2008-01. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01207375?
The interventions under investigation include: memory retraining exercises (BEHAVIORAL), placebo control memory exercises (BEHAVIORAL).
Who is sponsoring clinical trial NCT01207375?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
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