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Memory Enhancement Technique for Traumatic Brain Injury (STEM Trial)

N/A

Recruiting

Led By Nancy Chiaravalloti, PhD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18-65

Be older than 18 years old

Must not have

History of prior stroke or neurological injury/disease other than TBI

History of significant psychiatric illness (e.g., bipolar disorder, schizophrenia, or psychosis) or current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a memory enhancement technique for people with TBI to see if it can help improve their memory and everyday functioning.

Who is the study for?

This trial is for English-speaking adults aged 18-65 who have had a traumatic brain injury (TBI) at least one year ago and are experiencing learning and memory difficulties. It's not suitable for those on certain medications, with significant psychiatric conditions like bipolar disorder or schizophrenia, a history of substance abuse treatment, or other neurological issues besides TBI.

What is being tested?

The STEM research study is testing the effectiveness of a memory enhancement technique called SME in individuals with moderate to severe TBI. The goal is to see if this strategy can improve their new learning and memory skills, potentially helping them function better daily.

What are the potential side effects?

Since the intervention involves cognitive techniques rather than medication, traditional side effects are not expected. However, participants may experience fatigue or frustration during cognitive tasks designed to enhance memory.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke or neurological condition, but not TBI.

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I have a history of serious mental health issues like bipolar disorder or schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self Report Deficits in Daily Life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STEMExperimental Treatment1 Intervention

The treatment group (TX) will complete 8 sessions of STEM (2 sessions per week for 4 weeks), Sessions are approximately 30-45 minutes long.

Group II: ControlledActive Control1 Intervention

During weeks 2-5, one group will undergo a memory enhancement protocol, used to improve memory functioning in individuals with neurological injuries. The other group will serve as a control group and complete memory exercises with the researcher.

0 / 3Eligibility criteria met