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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
Must not have
Use of medications to enhance cognitive function (e.g. Ritalin)
Initial Glascow Coma Score <13 or penetrating head injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 8 weeks

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.
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.
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
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication to improve my thinking abilities.
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I had a severe head injury or my initial consciousness level was low.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neuropsychological assessments
Secondary study objectives
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
37 Previous Clinical Trials
13,501 Total Patients Enrolled
Massachusetts Institute of TechnologyOTHER
101 Previous Clinical Trials
12,821,875 Total Patients Enrolled
Robert Van Boven, M.D.Principal InvestigatorThe Geneva Foundation

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
~13 spots leftby Jan 2026
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