Modified Story Memory Technique (mSMT) in Persons With TBI

NCT04056312 | Completed

• 1 other identifier: R-926-16
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The current RCT is designed to:

1. 1.test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning
2. 2.assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the mSMT, as well as additional questionnaires to be completed by both the participant and a significant other
3. 3.evaluate the changes in brain functioning following treatment with the mSMT via fMRI and
4. 4.evaluate the long-term effects of the treatment protocol.

Conditions

Traumatic Brain Injury

Keywords

memory; learning; cognition; traumatic brain injury; treatment and therapy

Outcome Measures

Primary Outcomes (2)

• California Verbal Learning Test

  Change on scores on memory tests will be assessed using the California Verbal Learning Test

  Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later

• The Traumatic Brain Injury-Quality of Life Scale

  Self-reports of emotional functioning, memory functioning and quality of life on The Traumatic Brain Injury-Quality of Life Scale, which measures these constructs. DVs will be change on the Depression subscale (range: 0-40; lower score is better) and Cognition scale (range: 0-40; higher score is better).

  Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later

Study Arms (2)

Group memory retraining

EXPERIMENTAL

Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Behavioral: Group Memory retraining exercises

Placebo

PLACEBO COMPARATOR

Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Behavioral: Placebo controlled group memory exercise training

Interventions

Group Memory retraining exercises BEHAVIORAL

Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Group memory retraining

Placebo controlled group memory exercise training BEHAVIORAL

Placebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I am between the ages of 18-65.
• I have had a Traumatic Brain Injury at least one year ago.
• I can read and speak English fluently.
• I have difficulties with learning and memory skills.

You may not qualify if:

• I am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications.
• I have had a prior stroke or neurological injury/disease other than a traumatic brain injury.
• I have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
• I have unstable or uncontrolled seizures.
• I have a significant alcohol or drug abuse history.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Richard Green, PhD

  Kessler Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director NNL & TBI

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 14, 2019
• Study Start: June 29, 2016
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

US (1)