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Behavioral Intervention
Cognitive Rehabilitation for Traumatic Brain Injury (TBPM Trial)
N/A
Waitlist Available
Led By Erica Weber, PhD
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
Awards & highlights
TBPM Trial Summary
This trial will test a computer program designed to improve thinking skills in people with TBI.
Who is the study for?
This trial is for English-speaking individuals who have had a moderate-to-severe traumatic brain injury (TBI) at least one year ago and are struggling with strategic thinking skills. It's not suitable for those with other serious neurological conditions, major psychiatric disorders like bipolar or schizophrenia, a history of substance abuse, or current steroid/benzodiazepine use.Check my eligibility
What is being tested?
The study is examining the effectiveness of a computer-based cognitive rehabilitation program aimed at enhancing thinking abilities in people who have suffered from TBI. Participants will engage with this digital therapy to see if it can help improve their memory and cognitive functions.See study design
What are the potential side effects?
Since the intervention involves cognitive exercises on a computer, side effects may be minimal but could include eye strain, headache, or fatigue due to the mental effort required by these tasks.
TBPM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intervention Tolerability Assessment Scale
Recruitment rate percentage
Retention rate percentage
Secondary outcome measures
Changes in strategic cognitive functions (performance on NIH EXAMINER)
Changes in time monitoring & time-based prospective memory
TBPM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
The experimental group will receive treatment program designed to train strategic cognitive functions. Sessions will last 50 minutes and take place twice per week for 16 weeks.
Group II: Control groupActive Control1 Intervention
The control group will receive no active treatment and will be treated as a "no-contact control" group.
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Who is running the clinical trial?
Kessler FoundationLead Sponsor
173 Previous Clinical Trials
10,699 Total Patients Enrolled
Erica Weber, PhDPrincipal Investigator - Kessler Foundation
Kessler Foundation
1 Previous Clinical Trials
24 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a serious head injury at least a year ago.I am currently using steroids or benzodiazepines.You have a history of significant neurological issues, other than a traumatic brain injury.You have a history of serious drug or alcohol abuse.Show difficulties with thinking and problem-solving skills.You have a history of serious mental health conditions like bipolar disorder or schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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