Modified Story Memory Technique (mSMT) in Persons With TBI

NCT04056312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-01-18

No results posted yet for this study

Summary

The current RCT is designed to:

1. test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning
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. evaluate the changes in brain functioning following treatment with the mSMT via fMRI and
4. evaluate the long-term effects of the treatment protocol.

To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT, applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30 treatment; 30 control).

Conditions

Interventions

BEHAVIORAL

Group Memory retraining exercises

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

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

Sponsors & Collaborators

  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Richard Green, PhD · Kessler Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-29
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056312 on ClinicalTrials.gov