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Behavioral Intervention

RT fMRI + Cognitive Training for Traumatic Brain Injury

N/A
Waitlist Available
Led By Robert Van Boven, M.D.
Research Sponsored by Van Boven, Robert W., M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-45 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 8 weeks
Awards & highlights

Study Summary

This trial will test the effects of two different types of training on cognitive abilities and symptoms in people with brain injuries. Brain function and structure will be measured before and after the training.

Who is the study for?
This trial is for individuals aged 18-45, right-handed, who have had a mild traumatic brain injury (TBI) within the past 4 to 36 months. They must be fluent in English and able to participate in fMRI scans and assessments. People with significant neurological or psychiatric disorders, drug abuse issues, MRI contraindications like metal implants or claustrophobia, or those on cognitive-enhancing drugs cannot join.Check my eligibility
What is being tested?
The study tests if real-time neurofeedback using functional MRI (RT fMRI) and/or an 8-week computer-based cognitive training program can help improve brain function after TBI. Participants are randomly assigned to receive either the active interventions or control tasks while their brain activity is monitored before and after treatment.See study design
What are the potential side effects?
Since this trial involves non-invasive techniques like RT fMRI and cognitive exercises rather than medication, traditional side effects are not expected. However, participants may experience discomfort from being in an MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neuropsychological assessments
Secondary outcome measures
Exercise Based Assessments
Functional Assessments
Participant-reported outcomes
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Exp RT fMRI/Exp Cognitive TrainingExperimental Treatment2 Interventions
Both experimental conditions.
Group II: Exp RT fMRI/Ctrl Cognitive trainingExperimental Treatment2 Interventions
Experimental real-time fMRI and control cognitive training.
Group III: Ctrl RT fMRI/Exp Cognitive TrainingExperimental Treatment2 Interventions
Control RT fMRI (real-time functional MRI) and experimental cognitive training.
Group IV: Ctr RT fMRI/Ctr Cognitive TrainingPlacebo Group2 Interventions
Control real-time fMRI and control cognitive training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Training
2008
Completed Phase 3
~4100

Find a Location

Who is running the clinical trial?

Van Boven, Robert W., M.D.Lead Sponsor
The Geneva FoundationOTHER
30 Previous Clinical Trials
12,244 Total Patients Enrolled
Massachusetts Institute of TechnologyOTHER
97 Previous Clinical Trials
12,729,837 Total Patients Enrolled

Media Library

Cognitive Training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT01908647 — N/A
Traumatic Brain Injury Research Study Groups: Exp RT fMRI/Exp Cognitive Training, Exp RT fMRI/Ctrl Cognitive training, Ctrl RT fMRI/Exp Cognitive Training, Ctr RT fMRI/Ctr Cognitive Training
Traumatic Brain Injury Clinical Trial 2023: Cognitive Training Highlights & Side Effects. Trial Name: NCT01908647 — N/A
Cognitive Training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01908647 — N/A

Frequently Asked Questions

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

Are researchers still looking to enlist participants in this research?

"According to clinicaltrial.gov, this research project is not currently recruiting patients and has not been since April 24th 2014; however, there are 707 other studies that have open enrollment at the moment."

Answered by AI

Is this experiment recruiting individuals who are beyond their fourth decade of life?

"The age range of participants accepted into this clinical trial is 18 to 45. Meanwhile, 105 trials are currently recruiting people younger than 18, and 542 studies seek seniors aged 65 or above."

Answered by AI

May I join the ranks of participants in this clinical trial?

"To partake in this trial, individuals must have suffered a traumatic brain injury (TBI) and be aged between 18 to 45. A total of 150 people are expected to take part."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Florida
California
Other
How old are they?
18 - 65
What site did they apply to?
Carl R Darnall Army Medical Center (CRDAMC)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
2014. "Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01908647.
All > Tb > Texas
~14 spots leftby Apr 2025
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