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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
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

STEM Trial 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.Check my eligibility
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.See study design
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.

STEM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

STEM Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self Report Deficits in Daily Life

STEM 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.

Find a Location

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
69 Previous Clinical Trials
8,297 Total Patients Enrolled
Kessler FoundationLead Sponsor
172 Previous Clinical Trials
10,583 Total Patients Enrolled
Nancy Chiaravalloti, PhDPrincipal Investigator - Kessler Foundation
Kessler Foundation
3 Previous Clinical Trials
178 Total Patients Enrolled

Media Library

SME Clinical Trial Eligibility Overview. Trial Name: NCT04054596 — N/A
Traumatic Brain Injury Research Study Groups: Controlled, STEM
Traumatic Brain Injury Clinical Trial 2023: SME Highlights & Side Effects. Trial Name: NCT04054596 — N/A
SME 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054596 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts ongoing for this clinical experiment?

"Affirmative. Clinicaltrials.gov attests to this trial's active recruitment status, which began on December 1st 2017 and was most recently updated September 29th 2021. The study is seeking 80 patients from one medical site."

Answered by AI

How many individuals are being recruited for this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently inviting participants to participate in the study which was initially shared on December 1st 2017 and recently revised on September 29th 2021. 80 patients are needed from a single site for data collection purposes."

Answered by AI

Do elderly individuals older than seventy-five qualify for enrollment in this experiment?

"Within the given age range of 18 to 65, this clinical trial is open for recruitment."

Answered by AI

Does this clinical trial qualify me to participate?

"The research project is looking for 80 individuals aged between 18-65 with a past history of traumatic brain injury (TBI). To be eligible, applicants must meet these requirements: I am within the aforesaid age range., My TBI occured over 12 months ago., I have enduring problems with cognitive functions."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Kessler Foundation
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Mar 2024