Improving New Learning and Memory in School Aged Children
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Story Memory Technique
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Pediatrics
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.
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Modified Story Memory Technique
Control
Arm Description
Outcomes
Primary Outcome Measures
CVLT-C Learning Slope
Memory
Secondary Outcome Measures
Full Information
NCT ID
NCT04741360
First Posted
February 3, 2021
Last Updated
February 3, 2021
Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Brain Injury Research
1. Study Identification
Unique Protocol Identification Number
NCT04741360
Brief Title
Improving New Learning and Memory in School Aged Children
Official Title
Improving New Learning and Memory in School Aged Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
September 29, 2021 (Anticipated)
Study Completion Date
October 29, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Brain Injury Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified Story Memory Technique
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Modified Story Memory Technique
Intervention Description
10-session computerized program to improve new learning and memory
Primary Outcome Measure Information:
Title
CVLT-C Learning Slope
Description
Memory
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Moore, MA
Phone
973-324-8450
Ext
8450
Email
nbmoore@kesslerfoundation.org
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy B Moore, MA
Phone
973-324-8450
Ext
8450
Email
nbmoore@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nancy Chiarvalotti, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving New Learning and Memory in School Aged Children
We'll reach out to this number within 24 hrs