SME for Traumatic Brain Injury

Kessler Foundation, East Hanover, NJ
Traumatic Brain Injury+1 More ConditionsSME - Behavioral
Eligibility
18 - 65
All Sexes

Study 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.

Eligible Conditions
  • Traumatic Brain Injury
  • Cognitive Impairment

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)

Month 7
Self Report Deficits in Daily Life

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Controlled
1 of 2
STEM
1 of 2

Active Control

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: SME · No Placebo Group · N/A

STEM
Behavioral
Experimental Group · 1 Intervention: SME · Intervention Types: Behavioral
ControlledNoIntervention Group · 1 Intervention: Controlled · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
58 Previous Clinical Trials
7,003 Total Patients Enrolled
Kessler FoundationLead Sponsor
160 Previous Clinical Trials
10,290 Total Patients Enrolled
Nancy Chiaravalloti, PhDPrincipal Investigator - Kessler Foundation
Kessler Foundation
3 Previous Clinical Trials
178 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You had a serious head injury at least one year ago.
You have problems with remembering and understanding things.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Kessler Foundation100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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](https://www.withpower.com/clinical-trials/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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.