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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04741360
Other study ID # R-987-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2017
Est. completion date November 15, 2021

Study information

Verified date March 2024
Source Kessler Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.


Description:

The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date November 15, 2021
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender All
Age group 9 Years to 17 Years
Eligibility Inclusion Criteria: - Be between the ages of 9 and 17. - Have sustained a TBI at least 1 year ago, that has affected his or her memory. - Be able to speak and read English fluently. Exclusion Criteria: - Diagnosis of MS, or neurological injury or disease in the past (like brain tumor or epilepsy). - History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis). - Uncontrolled seizures or other unstable medical complications.

Study Design


Intervention

Other:
Modified Story Memory Technique
10-session computerized program to improve new learning and memory

Locations

Country Name City State
United States Kessler Foundation East Hanover New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Kessler Foundation New Jersey Commission on Brain Injury Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CVLT-C Learning Slope Memory 6 months
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