Clinical trial NCT04741360: Improving New Learning and Memory in School Aged Children
Official title: Improving New Learning and Memory in School Aged Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Pediatrics
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: New Jersey Commission on Brain Injury Research
First posted: 2021-02-05
Enrollment: 9
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: CVLT-C Learning Slope
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: